Accidental FallNCT04308239
Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls
A study testing Reactive balance training and Otago Balance Training in people with Accidental Fall, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
The goal of this study was to evaluate the effects of reactive balance training (RBT) targeting slipping and tripping on laboratory-induced slips and trips. In an effort to build upon prior work, the present study included: 1) a control group receiving an alternative balance training intervention; 2) separate training… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall
- What is being tested?
- Reactive balance training and Otago Balance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Jul 2019
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) pass a medical history and screening administered by a physician that excluded participants with osteoporosis of the lumbar spine or proximal femur as assessed by Dual Energy X-ray Absorptiometry (Lunar iDXA, GE Healthcare, Chicago, IL), or any unstable or progressive medical conditions that could contribute to imbalance or falls
Who cannot join
- smoked
- were in physical therapy
- had a self-reported fragility fracture within the last 10 years
- had an acute lower extremity injury within the last 3 months
- had lower extremity surgery within the last six months
- had an ankle arthroplasty
- had a knee or hip arthroplasty within the last 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Tech - Department of Industrial and Systems Engineering
Blacksburg, Virginia, 24061
About this study
Official title: Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls Among Older Adults: a Pilot Randomized Controlled Trial
The goal of this study was to evaluate the effects of reactive balance training (RBT) targeting slipping and tripping on laboratory-induced slips and trips. In an effort to build upon prior work, the present study included: 1) a control group receiving an alternative balance training intervention; 2) separate training and assessment sessions; 3) alternative RBT methods that may be more amenable to work outside the lab compared to prior methods, and 4) older adult participants receiving individualized training to reduce drop-out. The investigators hypothesized that slips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial slips before any intervention or after a control intervention. The investigators also hypothesized that trips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial trips before any intervention or after a control intervention. Results were intended to contribute to knowledge regarding the efficacy of alternative methods for RBT, and provide additional evidence regarding its efficacy.
- Conditions
- Accidental Fall
- Being tested
- Reactive balance training, Otago Balance Training
- Keywords
- balance training, step training, perturbation-based balance training, dynamic balance, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive balance trainingBehavioural
Participants were exposed to simulated trips and slips under safe, controlled conditions in order to practice their reactive response to these common balance perturbations.
Otago Balance TrainingBehavioural
Balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).
| Study group | Role | What they receive |
|---|---|---|
| Reactive balance training | Experimental | Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant.
Reactive balance training involved both slip and trip training.
Slip training involved repeatedly stepping onto a low-friction interface (nylon fabric placed over a 0.9 × 0.9 meter polycarbonate sheet) while practicing controlling/decelerating the slipping foot and properly positioning the non-slipping foot under the pelvis.
Trip training involved repeatedly practicing recovery from simulated trips on a modified treadmill. While standing on a modified treadmill, the treadmill belt was quickly accelerated posteriorly to elicit a forward loss of balance that mimicked a trip while walking. Participants attempted to step to avert a fall, and to establish a stable gait on the treadmill, after which the treadmill speed was slowed to zero to complete the trial. Receives: Behavioral: Reactive balance training |
| Control balance training | Active comparator | Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant.
The control intervention involved general balance exercises adapted from the Otago Exercise program. Briefly, all four sessions involved balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support). Receives: Behavioral: Otago Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Slip Speed
highest instantaneous speed of slipping foot during actual slip
Measured: during week 1, before the intervention that spanned weeks 2 and 3
Peak Slip Speed
highest instantaneous speed of slipping foot during actual slip
Measured: during week 4, after the intervention that spanned weeks 2 and 3
Trunk Angle at Touchdown After Tripping
anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle
Measured: during week 1, before the intervention that spanned weeks 2 and 3
Trunk Angle at Touchdown After Tripping
anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle
Measured: during week 4, after the intervention that spanned weeks 2 and 3
Secondary outcomes (8)
Slip Distance
distance moved by slipping foot during actual slip
Measured: during week 1, before the intervention that spanned weeks 2 and 3
Slip Distance
distance moved by slipping foot during actual slip
Measured: during week 4, after the intervention that spanned weeks 2 and 3
Fall Incidence After a Laboratory-induced Slip
the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted
Measured: during week 1, before the intervention that spanned weeks 2 and 3
Fall Incidence After a Laboratory-induced Slip
the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted
Measured: during week 4, after the intervention that spanned weeks 2 and 3
Recovery Step Length After Tripping
anterior-posterior step distance of first step over tripping obstacle
Measured: during week 1, before the intervention that spanned weeks 2 and 3
Recovery Step Length After Tripping
anterior-posterior step distance of first step over tripping obstacle
Measured: during week 4, after the intervention that spanned weeks 2 and 3
Fall Incidence After a Laboratory-induced Trip
the outcome of each trip was categorized as a: fall, recovery, or harness-assisted
Measured: during week 1, before the intervention that spanned weeks 2 and 3
Fall Incidence After a Laboratory-induced Trip
the outcome of each trip was categorized as a: fall, recovery, or harness-assisted
Measured: during week 4, after the intervention that spanned weeks 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Jun 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
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 (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A two-group, pretest-posttest parallel design was employed. Participants were first assigned to either the reactive balance training or control intervention using minimization. During the first week, participants completed a pre-intervention assessment involving exposure to a single laboratory-induced slip or trip based upon random assignment. During the second and third weeks, participants completed a total of four sessions of their assigned intervention (two sessions per week for two weeks). During the fourth week, participants completed a post-intervention assessment involving exposure to the other perturbation (slip or trip) that they did not experience during the pre-intervention assessment. This design was selected to evaluate gait and reactive balance prior to any training intervention, and to avoid any unintended training effects induced by exposing participants to the same perturbation more than once.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Madigan, Virginia Polytechnic Institute and State University
- Investigators
- Michael L Madigan, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308239
- Sponsor's protocol ID
- 18-486
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 18 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allin LJ, Brolinson PG, Beach BM, Kim S, Nussbaum MA, Roberto KA, Madigan ML. Perturbation-based balance training targeting both slip- and trip-induced falls among older adults: a randomized controlled trial. BMC Geriatr. 2020 Jun 12;20(1):205. doi: 10.1186/s12877-020-01605-9.
PubMed 32532221
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls Among Older Adults: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04308239
- Acronym / sponsor ID
- 18-486
- Conditions
- Accidental Fall
- Keywords
- balance training, step training, perturbation-based balance training, dynamic balance, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Posted 18 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study was to evaluate the effects of reactive balance training (RBT) targeting slipping and tripping on laboratory-induced slips and trips. In an effort to build upon prior work, the present study included: 1) a control group receiving an alternative balance training intervention; 2) separate training and assessment sessions; 3) alternative RBT methods that may be more amenable to work outside the lab compared to prior methods, and 4) older adult participants receiving individualized training to reduce drop-out. The investigators hypothesized that slips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial slips before any intervention or after a control intervention. The investigators also hypothesized that trips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial trips before any intervention or after a control intervention. Results were intended to contribute to knowledge regarding the efficacy of alternative methods for RBT, and provide additional evidence regarding its efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-group, pretest-posttest parallel design was employed. Participants were first assigned to either the reactive balance training or control intervention using minimization. During the first week, participants completed a pre-intervention assessment involving exposure to a single laboratory-induced slip or trip based upon random assignment. During the second and third weeks, participants completed a total of four sessions of their assigned intervention (two sessions per week for two weeks). During the fourth week, participants completed a post-intervention assessment involving exposure to the other perturbation (slip or trip) that they did not experience during the pre-intervention assessment. This design was selected to evaluate gait and reactive balance prior to any training intervention, and to avoid any unintended training effects induced by exposing participants to the same perturbation more than once.
| Arm | Type | Receives |
|---|---|---|
| Reactive balance training | Experimental | Behavioral: Reactive balance trainingFour training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant. Reactive balance training involved both slip and trip training. Slip training involved repeatedly stepping onto a low-friction interface (nylon fabric placed over a 0.9 × 0.9 meter polycarbonate sheet) while practicing controlling/decelerating the slipping foot and properly positioning the non-slipping foot under the pelvis. Trip training involved repeatedly practicing recovery from simulated trips on a modified treadmill. While standing on a modified treadmill, the treadmill belt was quickly accelerated posteriorly to elicit a forward loss of balance that mimicked a trip while walking. Participants attempted to step to avert a fall, and to establish a stable gait on the treadmill, after which the treadmill speed was slowed to zero to complete the trial. |
| Control balance training | Active comparator | Behavioral: Otago Balance TrainingFour training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant. The control intervention involved general balance exercises adapted from the Otago Exercise program. Briefly, all four sessions involved balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support). |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) pass a medical history and screening administered by a physician that excluded participants with osteoporosis of the lumbar spine or proximal femur as assessed by Dual Energy X-ray Absorptiometry (Lunar iDXA, GE Healthcare, Chicago, IL), or any unstable or progressive medical conditions that could contribute to imbalance or falls
Key exclusion criteria (7 listed)
- smoked
- were in physical therapy
- had a self-reported fragility fracture within the last 10 years
- had an acute lower extremity injury within the last 3 months
- had lower extremity surgery within the last six months
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 |
|---|---|---|
| Reactive balance trainingParticipants were exposed to simulated trips and slips under safe, controlled conditions in order to practice their reactive response to these common balance perturbations. | Behavioural | Reactive balance training |
| Otago Balance TrainingBalance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support). | Behavioural | Control balance training |
Primary outcome
Peak Slip Speed
Time frame: during week 1, before the intervention that spanned weeks 2 and 3
highest instantaneous speed of slipping foot during actual slip
Peak Slip Speed
Time frame: during week 4, after the intervention that spanned weeks 2 and 3
highest instantaneous speed of slipping foot during actual slip
Trunk Angle at Touchdown After Tripping
Time frame: during week 1, before the intervention that spanned weeks 2 and 3
anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle
Trunk Angle at Touchdown After Tripping
Time frame: during week 4, after the intervention that spanned weeks 2 and 3
anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle
8 secondary outcomes
Slip Distance
Time frame: during week 1, before the intervention that spanned weeks 2 and 3
Slip Distance
Time frame: during week 4, after the intervention that spanned weeks 2 and 3
Fall Incidence After a Laboratory-induced Slip
Time frame: during week 1, before the intervention that spanned weeks 2 and 3
Fall Incidence After a Laboratory-induced Slip
Time frame: during week 4, after the intervention that spanned weeks 2 and 3
Recovery Step Length After Tripping
Time frame: during week 1, before the intervention that spanned weeks 2 and 3
Recovery Step Length After Tripping
Time frame: during week 4, after the intervention that spanned weeks 2 and 3
Fall Incidence After a Laboratory-induced Trip
Time frame: during week 1, before the intervention that spanned weeks 2 and 3
Fall Incidence After a Laboratory-induced Trip
Time frame: during week 4, after the intervention that spanned weeks 2 and 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32532221Allin LJ, Brolinson PG, Beach BM, Kim S, Nussbaum MA, Roberto KA, Madigan ML. Perturbation-based balance training targeting both slip- and trip-induced falls among older adults: a randomized controlled trial. BMC Geriatr. 2020 Jun 12;20(1):205. doi: 10.1186/s12877-020-01605-9.
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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.
Michael L Madigan, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reactive balance training and Otago Balance Training in people with Accidental Fall, run by Virginia Polytechnic Institute and State University 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 1 inclusion and 7 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 18 May 2020. 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 18 May 2020). 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?
Peak Slip Speed (time frame: during week 1, before the intervention that spanned weeks 2 and 3). The study lists 4 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 NCT04308239, which also lists 1 linked publication.
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 18 May 2020.