Community Mobility of Older AdultsNCT04934956
Increasing Gait Automaticity in Older Adults by Exploiting Locomotor Adaptation
A study testing Split-belt walking and Multiple transitions between split-belt and tied-belt walking in people with Community Mobility of Older Adults and Locomotor Adaptability, run by University of Pittsburgh at 1 site in United States.
Trial summary
The investigators will test the following: 1) the extent of locomotor adaptation improvement; 2) the association between initial walking automaticity (i.e. less PFC activity while walking with a cognitive load) and prefrontal-subcortical function (measured via neuropsychological testing); and 3) whether improvements… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community Mobility of Older Adults, Locomotor Adaptability, Gait Automaticity
- What is being tested?
- Split-belt walking and Multiple transitions between split-belt and tied-belt walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 10 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 years old or older.
- Body Mass Index of 35 or less. Muscle activities will be recorded for distinct muscles in the legs and fatty tissue could interfere with these measurements.
- Able to walk without a hand held device
- Able to walk for 5 minutes at their self-paced speed
Who cannot join
- Any past or present history of neurological disorders, heart or respiratory disease, brain injury, seizures, spinal cord surgery, or strokes.
- Pregnancy.
- Unable to follow two part commands;
- Uncorrected vision or severe visual impairment with visual acuity < 20/70 with best correction;
- Cognitive impairments defined as modified mini-mental score <84;
- orthopedic or pain conditions (lower extremity pain, back pain, calf pain);
Show all 15Show fewer
- refuse to walk on a treadmill;
- hospitalized 6 months prior to the study for acute illness or surgery, other than minor surgical procedures;
- lower extremity orthopedic surgery within 1 year;
- uncontrolled hypertension (> 190/110 mmHg);
- diagnosed dementia;
- dyspnea at rest or during daily leaving activities;
- use supplemental oxygen, resting heart rate> 100 or <40 beats per minute;
- fixed or fused hip, knee, or ankle joints;
- progressive movement disorder such as Multiple Sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), or Parkinson's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Sensorimotor Learning Laboratory, Schenley Place Suite 110
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Locomotor Adaptability for Community Mobility of Older Adults: The Role of Gait Automaticity
The investigators will test the following: 1) the extent of locomotor adaptation improvement; 2) the association between initial walking automaticity (i.e. less PFC activity while walking with a cognitive load) and prefrontal-subcortical function (measured via neuropsychological testing); and 3) whether improvements in locomotor adaptability result in improvements in the Functional Gait Assessment (FGA), a clinically relevant indicator of dynamic balance and mobility in older adults. To answer these questions, the investigators will combine innovative techniques from multiple laboratories at the University of Pittsburgh. Automatic motor control (Dr. Rosso's expertise) will be assessed by wireless functional near-infrared spectroscopy (fNIRS) of the PFC during challenged walking conditions (walking on an uneven surface and walking while reciting every other letter of the alphabet). fNIRS allows for real-time assessment of cortical activity while a participant is upright and moving by way of light-based measurements of changes in oxygenated and deoxygenated hemoglobin. Locomotor adaptation (Dr. Torres-Oviedo's expertise) will be evaluated with a split-belt walking protocol (i.e., legs moving at different speeds) that the investigators and others have used to robustly quantify motor adaptation capacity in older individuals and have shown to be reliant on cerebellar and basal ganglia function. The investigators will focus on two important aspects of locomotor adaptation that the investigators have quantified before: (Aim 1) rate at which individuals adapt to the new (split) walking environment and (Aim 2) capacity to transition between distinct walking patterns (i.e., the split-belt and the overground walking patterns), defined as motor switching. Adaptation rate and motor switching are quantified using step length asymmetry, which is the difference between a step length taken with one leg vs. the other. The investigators will focus on this gait parameter because it robustly characterizes gait adaptation evoked by split-belt walking protocols. Finally, the investigators will quantify participant's cognitive function (Dr. Weinstein's expertise) through neuropsychological battery sensitive to prefrontal-subcortical function. The investigators will mainly focus on evaluating 1) learning capacity reliant on cerebellar structures and 2) assessing executive function heavily reliant on PFC and, to a lesser extent, the basal ganglia.
Read the detailed description
Restrictions in community mobility, the ability to move outside of one's home, are common in older ages and contribute to disability, institutionalization, and poor quality of life. Successful community mobility requires rapid integration of information from both external (e.g. surface quality, distances) and internal (e.g. fatigue, pain) to the individual. Under normal conditions, integration of these inputs occurs in subcortical-frontal (e.g., basal ganglia and cerebellum to primary motor cortex) networks and favors automatic motor control with few demands on the attention- related networks that primarily reside in the prefrontal cortex (PFC). As gait automaticity diminishes in older adults6, activation of the PFC during walking tasks increases. Lack of gait automaticity can interfere with community mobility, as the PFC is no longer free to process other information for navigating community environments. Another potential contributor to reduced community mobility is diminished locomotor adaptation. Specifically, older adults are slower at adjusting their movements while interacting with a new environment and have more difficulty switching motor patterns when transitioning across distinct walking conditions. This difficulty in switching motor patterns is related to cognitive switching ability, which is reliant upon similar subcortical-frontal processes that underlie motor control. While locomotor adaptation is reduced in normal aging, data from our lab indicates that older adults maintain plasticity and can improve locomotor adaptation. Our central hypothesis is that the ability to improve locomotor adaptation is greater in those with higher gait automaticity and greater integrity of the prefrontal-subcortical connections.
The extent of gait automaticity can be tested by increasing the cognitive load during walking (e.g., completing a cognitive task while walking) and measuring the related PFC response. Small changes in PFC activity and motor performance in response to the imposed cognitive load indicate intact gait automaticity. Conversely, a large change in PFC activity to maintain motor performance with addition of a cognitive load indicates diminished gait automaticity. Locomotor adaptability can be measured by manipulating walking context on a split-belt treadmill where the legs are moving at different speeds. Adaptation rate to the split-belt environment can be measured as well as the ability to switch motor patterns from the split-belt to overground walking. Promising data from our labs (n=8) indicate that older participants improve locomotor adaptation after experiencing multiple transitions between the split condition (belts' speed ratio 2:1) and regular walking (belts' speed ratio 1:1). However, neither the underlying mechanisms nor the clinical relevance of such improvements are known.
The investigators will test the following: 1) the extent of locomotor adaptation improvement in individuals aged 65 years and older; 2) the association between initial walking automaticity (i.e. less PFC activity while walking with a cognitive load) and prefrontal-subcortical function (measured via neuropsychological testing); and 3) whether improvements in locomotor adaptability result in improvements in the Functional Gait Assessment (FGA), a clinically relevant indicator of dynamic balance and mobility in older adults. To answer these questions, the investigators will combine innovative techniques from multiple laboratories at the University of Pittsburgh. Automatic motor control (Dr. Rosso's expertise) will be assessed by wireless functional near-infrared spectroscopy (fNIRS) of the PFC during challenged walking conditions (walking on an uneven surface and walking while reciting every other letter of the alphabet). fNIRS allows for real-time assessment of cortical activity while a participant is upright and moving by way of light-based measurements of changes in oxygenated and deoxygenated hemoglobin. Locomotor adaptation (Dr. Torres-Oviedo's expertise) will be evaluated with a split-belt walking protocol (i.e., legs moving at different speeds) that the investigators and others have used to robustly quantify motor adaptation capacity in older individuals and have shown to be reliant on cerebellar and basal ganglia function. The investigators will focus on two important aspects of locomotor adaptation that the investigators have quantified before: (Aim 1) rate at which individuals adapt to the new (split) walking environment and (Aim 2) capacity to transition between distinct walking patterns (i.e., the split-belt and the overground walking patterns), defined as motor switching. Adaptation rate and motor switching are quantified using step length asymmetry, which is the difference between a step length taken with one leg vs. the other. The investigators will focus on this gait parameter because it robustly characterizes gait adaptation evoked by split-belt walking protocols. Finally, the investigators will quantify participant's cognitive function (Dr. Weinstein's expertise) through neuropsychological battery sensitive to prefrontal-subcortical function. The investigators will mainly focus on evaluating 1) learning capacity reliant on cerebellar structures and 2) assessing executive function heavily reliant on PFC and, to a lesser extent, the basal ganglia.
With this data, the investigators will be able to address the following Aims:
Aim 1. Determine the association between improved locomotor adaptation rate and 1) individuals' gait automaticity and 2) cognitive function. Hypothesis: changes in adaptation rate will be predicted by initial walking automaticity and cerebellar-mediated learning capacity. This is predicated on the evidence that motor adjustments during split-belt walking depend on basal ganglia and cerebellar function.
Aim 2. Determine the association between improved locomotor switching and individuals' gait automaticity and cognitive function. Hypothesis: initial walking automaticity and executive control will predict improvements in locomotor switching. This is predicated on the evidence that motor switching is directly associated with basal ganglia-dependent cognitive tasks such as set-shifting.
Aim 3. Determine the extent to which improved locomotor adaptability could improve mobility. Hypothesis: changes in locomotor adaptability will not be exclusive to the laboratory context but will generalize to other locomotor tasks that require adaptability, as measured in the Functional Gait Assessment.
These results will provide strong preliminary data for a future study to explore these associations in a larger sample with more comprehensive measures of mobility contributors, neuroimaging for integrity of key brain regions, and objective measures of community mobility. These results will identify novel contributors to loss of community mobility in older adults and could identify novel therapeutic targets for interventions that improve gait adaptation to prevent falls and enhance independence.
- Being tested
- Split-belt walking, Multiple transitions between split-belt and tied-belt walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-belt walkingOther
These will be used in all experiments and consists of a time period during which the legs move at different speeds (0.5 m/s vs. 1 m/s). The investigators select those speeds since the investigators have observed in our preliminary data and published study (Sombric et al. 2017) that older individuals adapted at these speeds exhibit large deficits at motor switching when transitioning to overground walking. This large reference signal will facilitate the detection of a change in motor switching (Aim 2) following the Intervention.
Multiple transitions between split-belt and tied-belt walkingOther
This intervention consists of multiple short adaptation blocks (i.e., 5 blocks of 200 strides each) interleaved with short de-adaptation blocks (i.e., 4 blocks of 50 strides of tied-belt walking each). It was designed based on several studies showing improvements in adaptation rate in young adults with a similar protocol (Malone et al. 2011; Day et al. 2018; Leech et al. 2018).
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Split-belt walking; Multiple transitions between split-belt and tied-belt walking | Experimental | Split-belt walking will be used in all experiments and consists of a time period during which the legs move at different speeds (0.5 m/s vs. 1 m/s). The investigators select those speeds since the investigators have observed in our preliminary data and published study (Sombric et al. 2017) that older individuals adapted at these speeds exhibit large deficits at motor switching when transitioning to overground walking. This large reference signal will facilitate the detection of a change in motor switching (Aim 2) following the Intervention.
This second intervention consists of multiple short adaptation blocks (i.e., 5 blocks of 200 strides each) interleaved with short de-adaptation blocks (i.e., 4 blocks of 50 strides of tied-belt walking each). It was designed based on several studies showing improvements in adaptation rate in young adults with a similar protocol (Malone et al. 2011; Day et al. 2018; Leech et al. 2018). Receives: Other: Split-belt walking; Other: Multiple transitions between split-belt and tied-belt walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adaptation Rate
Adaptation is measured by the mean of the step length asymmetry during the first 30 strides of in adaptation. This metric approximates the rate of learning. Higher adaptation rate means better learning rate. Step length asymmetry is defined as the normalized difference in bilateral step lengths (distance between ankles at heel stride), calculated as (step length of the dominant leg - step length of the non-dominant leg) divided by the sum of step lengths of the two legs. Step length asymmetry is a robust and clinically relevant measure conventionally used to characterize gait changes in split-belt walking where a zero value indicates that both steps are the same length.
The adaptation rate will be measured during the visits pre-intervention, during intervention and post-intervention. The changes through the process, most importantly before and after intervention, will be calculated. Larger the change, better the learning capacity.
Measured: 1-2 days pre-Intervention, during Intervention and 1-2 days post-Intervention
Change in Aftereffect
Aftereffect is the difference in step length asymmetry between the last 40 strides of baseline walking and the first 5 strides of walking over ground after adaptation. Higher aftereffect value represents higher transfer of the learning. Step length asymmetry is defined as the normalized difference in bilateral step lengths (distance between ankles at heel stride), calculated as (step length of the dominant leg - step length of the non-dominant leg) divided by the sum of step lengths of the two legs. Step length asymmetry is a robust and clinically relevant measure conventionally used to characterize gait changes in split-belt walking where a zero value indicates that both steps are the same length.
The aftereffects will be measured during the visits 1 week pre-intervention, during intervention and 1 week post-intervention. The changes through the process, most importantly before and after intervention, will be calculated. Larger the change, better the motor switching capacity.
Measured: 1-2 days pre-Intervention, during Intervention and 1-2 days post-Intervention
Change in FGA
Change in Functional gait assessment (FGA) score post-Intervention relative to pre-Intervention. The FGA consists of 10 items: gait on level surface, change in gait speed, gait with horizontal and vertical head turns, gait with 180° pivot turn, stepping over obstacles, gait with narrow base of support, gait with eyes closed, backwards gait and stairs. Scoring of each of these activities is done on a 4-point ordinal scale ranging from 0-3, with 0 indicating severe impairment (cannot perform without assistance, severe gait deviations or imbalance, increased time to perform task), 1 indicating moderate impairment, 2 indicating mild impairment, and 3 indicating normal ambulation (no gait or balance impairment, completion of task in a timely manner). All items are summed to calculate a total score (max. 30).
Measured: 1-2 days pre-Intervention and 1-2 days post-Intervention
Executive Function
Subtests of Delis-Kaplan Executive Function System (D-KEFS) will be used: (1) Color-Word Interference Task that measures the ability to inhibit a dominant and automatic verbal response (inhibition) and the ability to switch between inhibiting and executing an automatic verbal response (inhibition/switching); (2) Trail Making Test that measures flexibility of thinking and set-shifting ability on a visual-motor sequencing task (Condition 4), and (3) Verbal Fluency (for letters and categories) that measures letter fluency, category fluency, and category switching. The performance of each of test is measured by seconds to completion, except for verbal fluency, which is determined by total number of correct responses and switches between categories. Raw scores are normed using the D-KEFS normative data structure (mean = 10, SD = 3). All tests are co-normed to allow averaging to create a single, composite executive function measure. Higher score means better executive function.
Measured: 3-4 days pre-Intervention
Subcortical/Basal Ganglia Function
The Action verbal fluency test will be used to measure subcortical/basal ganglia cognitive function. This task requires the participant to rapidly generate as many verbs (i.e., "things that people do") as possible within 1 min. The score is the number of correct words within 1 minute, excluding rule-breaks and intrusions (i.e., non-verbs), from 0 to the max number of correct words participant can generate. The number of words generated is then converted to a population normative score. Higher score means better basal ganglia cognitive function.
Measured: 3-4 days pre-Intervention
Secondary outcomes (4)
Change in Prefrontal Cortex Activity
Gait automaticity will be quantified by changes in prefrontal cortical oxygenated hemoglobin (HbO) from quiet standing while counting silently to dual-task walking (walking while reciting every other letter of the alphabet). HbO is measured by an 8-channel continuous-wave functional near-infrared spectroscopy (fNIRS). A general linear model with a design matrix convolved with task timing and a canonical hemodynamic response function will be fitted to the data, and a Student's t-test will be performed on the regression coefficients and averaged over trials. A higher t-value represents more neural activity in dual-task walking relative to quiet standing.
Measured: 3-4 days pre-Intervention
Attention, Language, Immediate Memory, Delayed Memory, and Visuospatial Function Measures
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is an integrated, co-normed tool to measure cognitive performance across measures of attention, language, memory (immediate and delayed), and visuospatial ability. Each test is scored based on number correct in accordance with the test manual. Individual test scores are normed, then combined into predetermined index scores. Attention index is comprised of the digit span and coding subtests; language is comprised of the picture naming and semantic fluency subtests; immediate memory is comprised of the list and story learning subtests; delayed memory is comprised of the list recall, list recognition, story recall, and figure recall subtests; visuospatial construction is comprised of the figure copy and line orientation subtests. These individual index scores can be combined to generate an overall index standard. The score range is 40-154 (mean = 100 and SD = 15). Higher score means better cognitive performance.
Measured: 3-4 days pre-Intervention
Premorbid Estimated Verbal Ability
The Wechsler Test of Adult Reading (WTAR) estimates premorbid verbal ability/crystallized intellectual function. This is a measure that shows relative stability even in the face of cerebral trauma or insult, or neurodegenerative decline. As such, this provides an estimate of a participant's projected level of function for which to compare other measures of cognitive ability. Raw scores are converted to an estimated IQ/verbal ability score. The score ranges from 50 to 126 (mean = 100, SD = 15). Higher score means better verbal ability.
Measured: 3-4 days pre-Intervention
Switching Ability
The computer-based task inspired by Wisconsin Card Sorting Test will be used to quantify cognitive perseveration. There are four electronic cards displayed with a specific count of colored shapes on a monitor. Participants are showed a reference card and they must find the matching rule (count, shape, or color) by switching their matching strategy based on the feedback on each trial (e.g., if they match the card to the reference by color and they get "incorrect", in the next trial they can try to match by shape). Subjects perform a total a 128 matching trials, with 5 s to respond. Rule changes after 3-5 consecutive correct matches. The score is measured by perseveration error, computed as the total number of matches that were made based on a previous matching rule. The score range is 0-128. Higher score means poorer switching.
Measured: 3-4 days pre-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start8 Nov 2021
- Primary completion10 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Community Mobility of Older AdultsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), U.S. National Science Foundation, Central Research Development Fund, University of Pittsburgh Momentum Fund
- Responsible party
- Principal investigator, Gelsy Torres-Oviedo, University of Pittsburgh
- Investigators
- Gelsy Torres-Oviedo, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934956
- Sponsor's protocol ID
- STUDY19060017
- Other IDs
- K01NS092785-01A1, NSF 1535036, NSF 1847891, P30AG024827, CRDF 4.30204, 3455
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2021
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the publication (text, tables, figures, and appendices) will be shared on Open Science Framework for public access after de-identification.
Publications
Patla AE, Shumway-Cook A. Dimensions of mobility: Defining the complexity and difficulty associated with community mobility. J Aging Phys Activ. 1999;7(1):7-19.
Bentley JP, Brown CJ, McGwin G Jr, Sawyer P, Allman RM, Roth DL. Functional status, life-space mobility, and quality of life: a longitudinal mediation analysis. Qual Life Res. 2013 Sep;22(7):1621-32. doi: 10.1007/s11136-012-0315-3. Epub 2012 Nov 17.
PubMed 23161329Rantakokko M, Portegijs E, Viljanen A, Iwarsson S, Kauppinen M, Rantanen T. Changes in life-space mobility and quality of life among community-dwelling older people: a 2-year follow-up study. Qual Life Res. 2016 May;25(5):1189-97. doi: 10.1007/s11136-015-1137-x. Epub 2015 Sep 25.
PubMed 26407605Rosso AL, Taylor JA, Tabb LP, Michael YL. Mobility, disability, and social engagement in older adults. J Aging Health. 2013 Jun;25(4):617-37. doi: 10.1177/0898264313482489. Epub 2013 Apr 2.
PubMed 23548944Sheppard KD, Sawyer P, Ritchie CS, Allman RM, Brown CJ. Life-space mobility predicts nursing home admission over 6 years. J Aging Health. 2013 Sep;25(6):907-20. doi: 10.1177/0898264313497507. Epub 2013 Aug 21.
PubMed 23965310VanSwearingen JM, Studenski SA. Aging, motor skill, and the energy cost of walking: implications for the prevention and treatment of mobility decline in older persons. J Gerontol A Biol Sci Med Sci. 2014 Nov;69(11):1429-36. doi: 10.1093/gerona/glu153. Epub 2014 Sep 2.
PubMed 25182600Beurskens R, Helmich I, Rein R, Bock O. Age-related changes in prefrontal activity during walking in dual-task situations: a fNIRS study. Int J Psychophysiol. 2014 Jun;92(3):122-8. doi: 10.1016/j.ijpsycho.2014.03.005. Epub 2014 Mar 25.
PubMed 24681355Holtzer R, Mahoney JR, Izzetoglu M, Izzetoglu K, Onaral B, Verghese J. fNIRS study of walking and walking while talking in young and old individuals. J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):879-87. doi: 10.1093/gerona/glr068. Epub 2011 May 17.
PubMed 21593013Clark DJ, Rose DK, Ring SA, Porges EC. Utilization of central nervous system resources for preparation and performance of complex walking tasks in older adults. Front Aging Neurosci. 2014 Aug 25;6:217. doi: 10.3389/fnagi.2014.00217. eCollection 2014.
PubMed 25202270Fraser SA, Dupuy O, Pouliot P, Lesage F, Bherer L. Comparable Cerebral Oxygenation Patterns in Younger and Older Adults during Dual-Task Walking with Increasing Load. Front Aging Neurosci. 2016 Oct 20;8:240. doi: 10.3389/fnagi.2016.00240. eCollection 2016.
PubMed 27812334Holtzer R, Mahoney JR, Izzetoglu M, Wang C, England S, Verghese J. Online fronto-cortical control of simple and attention-demanding locomotion in humans. Neuroimage. 2015 May 15;112:152-159. doi: 10.1016/j.neuroimage.2015.03.002. Epub 2015 Mar 10.
PubMed 25765257Maidan I, Nieuwhof F, Bernad-Elazari H, Reelick MF, Bloem BR, Giladi N, Deutsch JE, Hausdorff JM, Claassen JA, Mirelman A. The Role of the Frontal Lobe in Complex Walking Among Patients With Parkinson's Disease and Healthy Older Adults: An fNIRS Study. Neurorehabil Neural Repair. 2016 Nov;30(10):963-971. doi: 10.1177/1545968316650426. Epub 2016 May 23.
PubMed 27221042Bohm S, Mademli L, Mersmann F, Arampatzis A. Predictive and Reactive Locomotor Adaptability in Healthy Elderly: A Systematic Review and Meta-Analysis. Sports Med. 2015 Dec;45(12):1759-77. doi: 10.1007/s40279-015-0413-9.
PubMed 26487633Herold F, Wiegel P, Scholkmann F, Thiers A, Hamacher D, Schega L. Functional near-infrared spectroscopy in movement science: a systematic review on cortical activity in postural and walking tasks. Neurophotonics. 2017 Oct;4(4):041403. doi: 10.1117/1.NPh.4.4.041403. Epub 2017 Aug 1.
PubMed 28924563Clark DJ. Automaticity of walking: functional significance, mechanisms, measurement and rehabilitation strategies. Front Hum Neurosci. 2015 May 5;9:246. doi: 10.3389/fnhum.2015.00246. eCollection 2015.
PubMed 25999838
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locomotor Adaptability for Community Mobility of Older Adults: The Role of Gait Automaticity
- ClinicalTrials.gov ID
- NCT04934956
- Acronym / sponsor ID
- STUDY19060017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), U.S. National Science Foundation, Central Research Development Fund, University of Pittsburgh Momentum Fund
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will test the following: 1) the extent of locomotor adaptation improvement; 2) the association between initial walking automaticity (i.e. less PFC activity while walking with a cognitive load) and prefrontal-subcortical function (measured via neuropsychological testing); and 3) whether improvements in locomotor adaptability result in improvements in the Functional Gait Assessment (FGA), a clinically relevant indicator of dynamic balance and mobility in older adults. To answer these questions, the investigators will combine innovative techniques from multiple laboratories at the University of Pittsburgh. Automatic motor control (Dr. Rosso's expertise) will be assessed by wireless functional near-infrared spectroscopy (fNIRS) of the PFC during challenged walking conditions (walking on an uneven surface and walking while reciting every other letter of the alphabet). fNIRS allows for real-time assessment of cortical activity while a participant is upright and moving by way of light-based measurements of changes in oxygenated and deoxygenated hemoglobin. Locomotor adaptation (Dr. Torres-Oviedo's expertise) will be evaluated with a split-belt walking protocol (i.e., legs moving at different speeds) that the investigators and others have used to robustly quantify motor adaptation capacity in older individuals and have shown to be reliant on cerebellar and basal ganglia function. The investigators will focus on two important aspects of locomotor adaptation that the investigators have quantified before: (Aim 1) rate at which individuals adapt to the new (split) walking environment and (Aim 2) capacity to transition between distinct walking patterns (i.e., the split-belt and the overground walking patterns), defined as motor switching. Adaptation rate and motor switching are quantified using step length asymmetry, which is the difference between a step length taken with one leg vs. the other. The investigators will focus on this gait parameter because it robustly characterizes gait adaptation evoked by split-belt walking protocols. Finally, the investigators will quantify participant's cognitive function (Dr. Weinstein's expertise) through neuropsychological battery sensitive to prefrontal-subcortical function. The investigators will mainly focus on evaluating 1) learning capacity reliant on cerebellar structures and 2) assessing executive function heavily reliant on PFC and, to a lesser extent, the basal ganglia.
Detailed description
Restrictions in community mobility, the ability to move outside of one's home, are common in older ages and contribute to disability, institutionalization, and poor quality of life. Successful community mobility requires rapid integration of information from both external (e.g. surface quality, distances) and internal (e.g. fatigue, pain) to the individual. Under normal conditions, integration of these inputs occurs in subcortical-frontal (e.g., basal ganglia and cerebellum to primary motor cortex) networks and favors automatic motor control with few demands on the attention- related networks that primarily reside in the prefrontal cortex (PFC). As gait automaticity diminishes in older adults6, activation of the PFC during walking tasks increases. Lack of gait automaticity can interfere with community mobility, as the PFC is no longer free to process other information for navigating community environments. Another potential contributor to reduced community mobility is diminished locomotor adaptation. Specifically, older adults are slower at adjusting their movements while interacting with a new environment and have more difficulty switching motor patterns when transitioning across distinct walking conditions. This difficulty in switching motor patterns is related to cognitive switching ability, which is reliant upon similar subcortical-frontal processes that underlie motor control. While locomotor adaptation is reduced in normal aging, data from our lab indicates that older adults maintain plasticity and can improve locomotor adaptation. Our central hypothesis is that the ability to improve locomotor adaptation is greater in those with higher gait automaticity and greater integrity of the prefrontal-subcortical connections.
The extent of gait automaticity can be tested by increasing the cognitive load during walking (e.g., completing a cognitive task while walking) and measuring the related PFC response. Small changes in PFC activity and motor performance in response to the imposed cognitive load indicate intact gait automaticity. Conversely, a large change in PFC activity to maintain motor performance with addition of a cognitive load indicates diminished gait automaticity. Locomotor adaptability can be measured by manipulating walking context on a split-belt treadmill where the legs are moving at different speeds. Adaptation rate to the split-belt environment can be measured as well as the ability to switch motor patterns from the split-belt to overground walking. Promising data from our labs (n=8) indicate that older participants improve locomotor adaptation after experiencing multiple transitions between the split condition (belts' speed ratio 2:1) and regular walking (belts' speed ratio 1:1). However, neither the underlying mechanisms nor the clinical relevance of such improvements are known.
The investigators will test the following: 1) the extent of locomotor adaptation improvement in individuals aged 65 years and older; 2) the association between initial walking automaticity (i.e. less PFC activity while walking with a cognitive load) and prefrontal-subcortical function (measured via neuropsychological testing); and 3) whether improvements in locomotor adaptability result in improvements in the Functional Gait Assessment (FGA), a clinically relevant indicator of dynamic balance and mobility in older adults. To answer these questions, the investigators will combine innovative techniques from multiple laboratories at the University of Pittsburgh. Automatic motor control (Dr. Rosso's expertise) will be assessed by wireless functional near-infrared spectroscopy (fNIRS) of the PFC during challenged walking conditions (walking on an uneven surface and walking while reciting every other letter of the alphabet). fNIRS allows for real-time assessment of cortical activity while a participant is upright and moving by way of light-based measurements of changes in oxygenated and deoxygenated hemoglobin. Locomotor adaptation (Dr. Torres-Oviedo's expertise) will be evaluated with a split-belt walking protocol (i.e., legs moving at different speeds) that the investigators and others have used to robustly quantify motor adaptation capacity in older individuals and have shown to be reliant on cerebellar and basal ganglia function. The investigators will focus on two important aspects of locomotor adaptation that the investigators have quantified before: (Aim 1) rate at which individuals adapt to the new (split) walking environment and (Aim 2) capacity to transition between distinct walking patterns (i.e., the split-belt and the overground walking patterns), defined as motor switching. Adaptation rate and motor switching are quantified using step length asymmetry, which is the difference between a step length taken with one leg vs. the other. The investigators will focus on this gait parameter because it robustly characterizes gait adaptation evoked by split-belt walking protocols. Finally, the investigators will quantify participant's cognitive function (Dr. Weinstein's expertise) through neuropsychological battery sensitive to prefrontal-subcortical function. The investigators will mainly focus on evaluating 1) learning capacity reliant on cerebellar structures and 2) assessing executive function heavily reliant on PFC and, to a lesser extent, the basal ganglia.
With this data, the investigators will be able to address the following Aims:
Aim 1. Determine the association between improved locomotor adaptation rate and 1) individuals' gait automaticity and 2) cognitive function. Hypothesis: changes in adaptation rate will be predicted by initial walking automaticity and cerebellar-mediated learning capacity. This is predicated on the evidence that motor adjustments during split-belt walking depend on basal ganglia and cerebellar function.
Aim 2. Determine the association between improved locomotor switching and individuals' gait automaticity and cognitive function. Hypothesis: initial walking automaticity and executive control will predict improvements in locomotor switching. This is predicated on the evidence that motor switching is directly associated with basal ganglia-dependent cognitive tasks such as set-shifting.
Aim 3. Determine the extent to which improved locomotor adaptability could improve mobility. Hypothesis: changes in locomotor adaptability will not be exclusive to the laboratory context but will generalize to other locomotor tasks that require adaptability, as measured in the Functional Gait Assessment.
These results will provide strong preliminary data for a future study to explore these associations in a larger sample with more comprehensive measures of mobility contributors, neuroimaging for integrity of key brain regions, and objective measures of community mobility. These results will identify novel contributors to loss of community mobility in older adults and could identify novel therapeutic targets for interventions that improve gait adaptation to prevent falls and enhance independence.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Split-belt walking; Multiple transitions between split-belt and tied-belt walking | Experimental | Other: Split-belt walking, Other: Multiple transitions between split-belt and tied-belt walkingSplit-belt walking will be used in all experiments and consists of a time period during which the legs move at different speeds (0.5 m/s vs. 1 m/s). The investigators select those speeds since the investigators have observed in our preliminary data and published study (Sombric et al. 2017) that older individuals adapted at these speeds exhibit large deficits at motor switching when transitioning to overground walking. This large reference signal will facilitate the detection of a change in motor switching (Aim 2) following the Intervention. This second intervention consists of multiple short adaptation blocks (i.e., 5 blocks of 200 strides each) interleaved with short de-adaptation blocks (i.e., 4 blocks of 50 strides of tied-belt walking each). It was designed based on several studies showing improvements in adaptation rate in young adults with a similar protocol (Malone et al. 2011; Day et al. 2018; Leech et al. 2018). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19 years old or older.
- Body Mass Index of 35 or less. Muscle activities will be recorded for distinct muscles in the legs and fatty tissue could interfere with these measurements.
- Able to walk without a hand held device
- Able to walk for 5 minutes at their self-paced speed
Key exclusion criteria (15 listed)
- Any past or present history of neurological disorders, heart or respiratory disease, brain injury, seizures, spinal cord surgery, or strokes.
- Pregnancy.
- Unable to follow two part commands;
- Uncorrected vision or severe visual impairment with visual acuity < 20/70 with best correction;
- Cognitive impairments defined as modified mini-mental score <84;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Split-belt walkingThese will be used in all experiments and consists of a time period during which the legs move at different speeds (0.5 m/s vs. 1 m/s). The investigators select those speeds since the investigators have observed in our preliminary data and published study (Sombric et al. 2017) that older individuals adapted at these speeds exhibit large deficits at motor switching when transitioning to overground walking. This large reference signal will facilitate the detection of a change in motor switching (Aim 2) following the Intervention. | Other | Intervention: Split-belt walking; Multiple transitions between split-belt and tied-belt walking |
| Multiple transitions between split-belt and tied-belt walkingThis intervention consists of multiple short adaptation blocks (i.e., 5 blocks of 200 strides each) interleaved with short de-adaptation blocks (i.e., 4 blocks of 50 strides of tied-belt walking each). It was designed based on several studies showing improvements in adaptation rate in young adults with a similar protocol (Malone et al. 2011; Day et al. 2018; Leech et al. 2018). | Other | Intervention: Split-belt walking; Multiple transitions between split-belt and tied-belt walking |
Primary outcome
Change in Adaptation Rate
Time frame: 1-2 days pre-Intervention, during Intervention and 1-2 days post-Intervention
Adaptation is measured by the mean of the step length asymmetry during the first 30 strides of in adaptation. This metric approximates the rate of learning. Higher adaptation rate means better learning rate. Step length asymmetry is defined as the normalized difference in bilateral step lengths (distance between ankles at heel stride), calculated as (step length of the dominant leg - step length of the non-dominant leg) divided by the sum of step lengths of the two legs. Step length asymmetry is a robust and clinically relevant measure conventionally used to characterize gait changes in split-belt walking where a zero value indicates that both steps are the same length. The adaptation rate will be measured during the visits pre-intervention, during intervention and post-intervention. The changes through the process, most importantly before and after intervention, will be calculated. Larger the change, better the learning capacity.
Change in Aftereffect
Time frame: 1-2 days pre-Intervention, during Intervention and 1-2 days post-Intervention
Aftereffect is the difference in step length asymmetry between the last 40 strides of baseline walking and the first 5 strides of walking over ground after adaptation. Higher aftereffect value represents higher transfer of the learning. Step length asymmetry is defined as the normalized difference in bilateral step lengths (distance between ankles at heel stride), calculated as (step length of the dominant leg - step length of the non-dominant leg) divided by the sum of step lengths of the two legs. Step length asymmetry is a robust and clinically relevant measure conventionally used to characterize gait changes in split-belt walking where a zero value indicates that both steps are the same length. The aftereffects will be measured during the visits 1 week pre-intervention, during intervention and 1 week post-intervention. The changes through the process, most importantly before and after intervention, will be calculated. Larger the change, better the motor switching capacity.
Change in FGA
Time frame: 1-2 days pre-Intervention and 1-2 days post-Intervention
Change in Functional gait assessment (FGA) score post-Intervention relative to pre-Intervention. The FGA consists of 10 items: gait on level surface, change in gait speed, gait with horizontal and vertical head turns, gait with 180° pivot turn, stepping over obstacles, gait with narrow base of support, gait with eyes closed, backwards gait and stairs. Scoring of each of these activities is done on a 4-point ordinal scale ranging from 0-3, with 0 indicating severe impairment (cannot perform without assistance, severe gait deviations or imbalance, increased time to perform task), 1 indicating moderate impairment, 2 indicating mild impairment, and 3 indicating normal ambulation (no gait or balance impairment, completion of task in a timely manner). All items are summed to calculate a total score (max. 30).
Executive Function
Time frame: 3-4 days pre-Intervention
Subtests of Delis-Kaplan Executive Function System (D-KEFS) will be used: (1) Color-Word Interference Task that measures the ability to inhibit a dominant and automatic verbal response (inhibition) and the ability to switch between inhibiting and executing an automatic verbal response (inhibition/switching); (2) Trail Making Test that measures flexibility of thinking and set-shifting ability on a visual-motor sequencing task (Condition 4), and (3) Verbal Fluency (for letters and categories) that measures letter fluency, category fluency, and category switching. The performance of each of test is measured by seconds to completion, except for verbal fluency, which is determined by total number of correct responses and switches between categories. Raw scores are normed using the D-KEFS normative data structure (mean = 10, SD = 3). All tests are co-normed to allow averaging to create a single, composite executive function measure. Higher score means better executive function.
Subcortical/Basal Ganglia Function
Time frame: 3-4 days pre-Intervention
The Action verbal fluency test will be used to measure subcortical/basal ganglia cognitive function. This task requires the participant to rapidly generate as many verbs (i.e., "things that people do") as possible within 1 min. The score is the number of correct words within 1 minute, excluding rule-breaks and intrusions (i.e., non-verbs), from 0 to the max number of correct words participant can generate. The number of words generated is then converted to a population normative score. Higher score means better basal ganglia cognitive function.
4 secondary outcomes
Change in Prefrontal Cortex Activity
Time frame: 3-4 days pre-Intervention
Attention, Language, Immediate Memory, Delayed Memory, and Visuospatial Function Measures
Time frame: 3-4 days pre-Intervention
Premorbid Estimated Verbal Ability
Time frame: 3-4 days pre-Intervention
Switching Ability
Time frame: 3-4 days pre-Intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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- Background: PubMed 23161329Bentley JP, Brown CJ, McGwin G Jr, Sawyer P, Allman RM, Roth DL. Functional status, life-space mobility, and quality of life: a longitudinal mediation analysis. Qual Life Res. 2013 Sep;22(7):1621-32. doi: 10.1007/s11136-012-0315-3. Epub 2012 Nov 17.
- Background: PubMed 26407605Rantakokko M, Portegijs E, Viljanen A, Iwarsson S, Kauppinen M, Rantanen T. Changes in life-space mobility and quality of life among community-dwelling older people: a 2-year follow-up study. Qual Life Res. 2016 May;25(5):1189-97. doi: 10.1007/s11136-015-1137-x. Epub 2015 Sep 25.
- Background: PubMed 23548944Rosso AL, Taylor JA, Tabb LP, Michael YL. Mobility, disability, and social engagement in older adults. J Aging Health. 2013 Jun;25(4):617-37. doi: 10.1177/0898264313482489. Epub 2013 Apr 2.
- Background: PubMed 23965310Sheppard KD, Sawyer P, Ritchie CS, Allman RM, Brown CJ. Life-space mobility predicts nursing home admission over 6 years. J Aging Health. 2013 Sep;25(6):907-20. doi: 10.1177/0898264313497507. Epub 2013 Aug 21.
- Background: PubMed 25182600VanSwearingen JM, Studenski SA. Aging, motor skill, and the energy cost of walking: implications for the prevention and treatment of mobility decline in older persons. J Gerontol A Biol Sci Med Sci. 2014 Nov;69(11):1429-36. doi: 10.1093/gerona/glu153. Epub 2014 Sep 2.
- Background: PubMed 24681355Beurskens R, Helmich I, Rein R, Bock O. Age-related changes in prefrontal activity during walking in dual-task situations: a fNIRS study. Int J Psychophysiol. 2014 Jun;92(3):122-8. doi: 10.1016/j.ijpsycho.2014.03.005. Epub 2014 Mar 25.
- Background: PubMed 21593013Holtzer R, Mahoney JR, Izzetoglu M, Izzetoglu K, Onaral B, Verghese J. fNIRS study of walking and walking while talking in young and old individuals. J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):879-87. doi: 10.1093/gerona/glr068. Epub 2011 May 17.
- Background: PubMed 25202270Clark DJ, Rose DK, Ring SA, Porges EC. Utilization of central nervous system resources for preparation and performance of complex walking tasks in older adults. Front Aging Neurosci. 2014 Aug 25;6:217. doi: 10.3389/fnagi.2014.00217. eCollection 2014.
- Background: PubMed 27812334Fraser SA, Dupuy O, Pouliot P, Lesage F, Bherer L. Comparable Cerebral Oxygenation Patterns in Younger and Older Adults during Dual-Task Walking with Increasing Load. Front Aging Neurosci. 2016 Oct 20;8:240. doi: 10.3389/fnagi.2016.00240. eCollection 2016.
- Background: PubMed 25765257Holtzer R, Mahoney JR, Izzetoglu M, Wang C, England S, Verghese J. Online fronto-cortical control of simple and attention-demanding locomotion in humans. Neuroimage. 2015 May 15;112:152-159. doi: 10.1016/j.neuroimage.2015.03.002. Epub 2015 Mar 10.
- Background: PubMed 27221042Maidan I, Nieuwhof F, Bernad-Elazari H, Reelick MF, Bloem BR, Giladi N, Deutsch JE, Hausdorff JM, Claassen JA, Mirelman A. The Role of the Frontal Lobe in Complex Walking Among Patients With Parkinson's Disease and Healthy Older Adults: An fNIRS Study. Neurorehabil Neural Repair. 2016 Nov;30(10):963-971. doi: 10.1177/1545968316650426. Epub 2016 May 23.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the publication (text, tables, figures, and appendices) will be shared on Open Science Framework for public access after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gelsy Torres-Oviedo, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-belt walking and Multiple transitions between split-belt and tied-belt walking in people with Community Mobility of Older Adults and Locomotor Adaptability, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adaptation Rate (time frame: 1-2 days pre-Intervention, during Intervention and 1-2 days post-Intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04934956, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.