Treadmill WalkingTOWNCT05541705
Treadmill Oscillation Walking to Improve Weight Transfer During Gait Following Stroke
A study testing Treadmill Oscillation Walking in people with Treadmill Walking, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study aims to determine the immediate and short-term effects of treadmill oscillation walking (TOW) exercise on hip and knee neuromechanics and gait characteristics in individuals post-stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treadmill Walking
- What is being tested?
- Treadmill Oscillation Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 31 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiparesis as a result of a stroke greater than 6 months previous to the study;
- A single cortical or subcortical stroke
- Able to walk 10 meters with or without a walking aid
- Able to stand unsupported for 5 minutes
- Sufficient cognitive function to follow instruction and communicate with the investigators.
- Reduced paretic limb loading more than 6% compared to the non-paretic limb during overground gait assessment
Who cannot join
- Medical condition precluding participant in regular exercise, such as acute cardiac or respiratory conditions limiting activity and other health conditions significantly impacting the ability to walk beyond the effects of the stroke, such as other neurological conditions or peripheral neuropathies;
- Bilateral stroke or a previous stroke in the contralateral hemisphere;
- Had a history of multiple strokes;
- Cerebellar stroke;
- Lower extremity joint replacement;
- Bone or joint problems that limited their ability to walk;
Show all 13Show fewer
- A resting heart rate outside of the range of 40 to 100 beats per minute;
- A resting blood pressure outside of the range of 90/60 to 170/90 mm Hg;
- Neglect;
- Hemianopia;
- Unexplained dizziness during the past 6 months;
- Chest pain or shortness of breath without exertion;
- Pregnancy by self-report.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular and Biomechanical Control of Weight Transfer During Gait in Individuals Post-stroke
This study aims to determine the immediate and short-term effects of treadmill oscillation walking (TOW) exercise on hip and knee neuromechanics and gait characteristics in individuals post-stroke. It was hypothesized that compared to baseline, individuals poststroke (N=15) will show increased hip abductor and knee extensor muscle activity and torque production, and increased limb loading and walking speeds during TOW and following a 6-week TOW intervention, reflecting that TOW can enhance gait function through improved hip and knee neuromechanical activation.
Read the detailed description
Fifteen participants with stroke will be enrolled to a longitudinal study that consists of a 6-week (18 sessions) TOW intervention, and gait evaluations at baseline and post-training and 1-month follow up. Kinematic, kinetic, and muscle activation pattern (electromyography, EMG) data will be recorded during pre- and post-training and 1 month follow-up evaluations.
Baseline evaluation:
- The participant will put on tight-fitting shorts and shirt. Hair ties will be donned to maintain clear lines of sight from cameras to markers.
- Overground gait assessment: Participants will walk at their self-selected and maximal walking speeds along an instrumented treadmill. Vertical ground reaction force will be recorded to characterize limb loading. Two familiarization trials will be provided and a safety belt will be worn by all participants. A study team member will walk alongside the participant to provide assistance if needed for safety.
- A study team member will place surface electrodes over the participants' gluteus medius (GM), tensor fasciae latae (TFL), and (Vastus lateralis) VL muscles using a wireless EMG system (Delsys Inc., Natick, MA).
- Participants will then perform the maximal voluntary isometric contraction (MVIC) test: During MVIC, a study team member will assess participants' maximal voluntary isometric knee extension and hip abduction torques with a dynamometer. Testing will begin with the less affected lower limb, followed immediately by the affected lower limb for participants with stroke. During knee extension MVIC, the participant will sit upright (85° from horizontal) with the lower leg strapped to the knee testing apparatus at a 60-degree knee flexion angle. The upper leg and torso will be stabilized with Velcro straps and a safety belt. Participants will be instructed to relax the opposite lower limb and rest their hands in their lap. During hip abduction MVIC, a marker will be placed to approximate the location of the hip center of rotation and the participant will be instructed to align the marker with the axis of motion of the dynamometer during standing. The test limb will be strapped to the Biodex input arm, with the lateral thigh pad just proximal to the knee. Hip abduction MVIC will be performed at a hip angle of 15° of abduction (Johnson et al. 2004). Each participant will be asked to push against the lateral thigh pad as hard and fast as they can. For both knee and Hip MVIC tests, 2 submaximal practice trials will be provided. A tester will stand beside the participant to encourage maximal efforts and to monitor alignment and correct movement execution. Two MVIC trials will be collected for each joint.
- Following the MVIC test, the participant will put on a safety harness with the assistance of the research team. Approximately 39 reflective markers will be attached to target locations on the participant's whole body (the head, arms, wrists, hands, trunk, pelvis, legs and feet) according to the Vicon Full-Body Plug-In Gait Model.
- Treadmill Gait Assessment: the participant will walk with their self-selected comfortable speed (SS) and maximal speed (MS) on a treadmill (Motek Inc., Columbus,OH) located in the Movement and Cognitive Rehabilitation Science core lab (BEL530). SS and MS will be determined by gradually increasing and decreasing the treadmill speed to ensure that each walking speed is identified by the participant. A 1-minute familiarization duration will be provided for each speed. Two 30-second baseline walking trials will be recorded for each walking speed. A handrail with a pressure sensing pad is located on the side of the treadmill. Participants will be instructed to only use the handrail if necessary for safety. Participants will wear a safety harness with no body weight support. Body segment position data will be recorded using a 10-camera motion capture system (Vicon-USA, Denver, CO). The motion capture cameras only record the marker trajectories and therefore this video recording contains no facial recognition information that can be used to identify the participant. Ground reaction forces will be captured by the instrumented split-belt treadmill (Motek Inc., Columbus, OH).
Testing will take approximately 3 hours.
Participants with stroke will then complete a 6-week gait training and a post-training and a 1-month follow up evaluation.
Participants will perform Treadmill and Overground Gait Assessments (described previously in Baseline Evaluation) after training and at 1-month follow-up. Post-training and follow-up testing sessions will be conducted a day and 1-month following the last training session, respectively.
- Conditions
- Treadmill Walking
- Being tested
- Treadmill Oscillation Walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill Oscillation WalkingBehavioural
Each participant with stroke will partake in 18 training sessions. Training sessions will be for one hour three times a week for 6 weeks. During training, participants will walk at their self-selected walking speed on the treadmill that moves side-to-side for 1 cm in a sinusoidal pattern. The sinusoidal oscillation frequency will match each participant's natural stride frequency calculated from baseline evaluation. Subjects will be instructed to respond naturally and maintain continuous walking. Participants will wear a safety harness with no body weight support. For each training session, six 6-minute bouts of treadmill oscillation trials will be performed (Hsiao et al. 2016) and rest period will be provided between bouts. Because lower extremity muscle activity increases with increasing oscillation frequency, the treadmill oscillation frequency will be increased by 5% each week to continue to drive progressive adaptive changes (25% over 6 weeks) (Pohl et al. 2002).
| Study group | Role | What they receive |
|---|---|---|
| TOW | Experimental | Treadmill Oscillation Walking training Receives: Behavioral: Treadmill Oscillation Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Vertical Ground Reaction Force in the Paretic Limb During Walking
changes in peak vertical ground reaction force from pre-training to post-training were calculated
Measured: pre-training, within one week after training completion (week 7)
Self Selected Walking Speed From Pre to Post Training During 10 Meter Walk Test
changes in self-selected walking speed from pre-training to post-training were calculated
Measured: pre-training, within one week after training completion (week 7)
Self-efficacy
changes in self-perceived balance and mobility ability from pre-training to post-training were calculated. It measures self-perceived balance, transfers, and walking abilities (e.g., standing unsupported, climbing stairs, walking fast).The range of the scale is 0 - 45, with higher values indicate higher self-perceived function.
Measured: pre-training, within one week after training completion (week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start15 Dec 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 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 (3)Papers the sponsor has linked to this study.
- Other trials for Treadmill WalkingStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore, Texas State University
- Responsible party
- Principal investigator, Hao-Yuan Hsiao, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541705
- Sponsor's protocol ID
- STUDY00002635
- Acronym
- TOW
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2022
- Last updated
- 26 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This proposed research will include data from approximately 15 subjects regarding their walking mechanics. Muscle activation patterns, body movement, and force production data will be recorded. Only de-identified data will be shared for research purposes.
Publications
Johnson ME, Mille ML, Martinez KM, Crombie G, Rogers MW. Age-related changes in hip abductor and adductor joint torques. Arch Phys Med Rehabil. 2004 Apr;85(4):593-7. doi: 10.1016/j.apmr.2003.07.022.
PubMed 15083435Hsiao H, Awad LN, Palmer JA, Higginson JS, Binder-Macleod SA. Contribution of Paretic and Nonparetic Limb Peak Propulsive Forces to Changes in Walking Speed in Individuals Poststroke. Neurorehabil Neural Repair. 2016 Sep;30(8):743-52. doi: 10.1177/1545968315624780. Epub 2015 Dec 31.
PubMed 26721869Pohl M, Mehrholz J, Ritschel C, Ruckriem S. Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. Stroke. 2002 Feb;33(2):553-8. doi: 10.1161/hs0202.102365.
PubMed 11823669
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular and Biomechanical Control of Weight Transfer During Gait in Individuals Post-stroke
- ClinicalTrials.gov ID
- NCT05541705
- Acronym / sponsor ID
- TOW / STUDY00002635
- Conditions
- Treadmill Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore, Texas State University
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Posted 26 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the immediate and short-term effects of treadmill oscillation walking (TOW) exercise on hip and knee neuromechanics and gait characteristics in individuals post-stroke. It was hypothesized that compared to baseline, individuals poststroke (N=15) will show increased hip abductor and knee extensor muscle activity and torque production, and increased limb loading and walking speeds during TOW and following a 6-week TOW intervention, reflecting that TOW can enhance gait function through improved hip and knee neuromechanical activation.
Detailed description
Fifteen participants with stroke will be enrolled to a longitudinal study that consists of a 6-week (18 sessions) TOW intervention, and gait evaluations at baseline and post-training and 1-month follow up. Kinematic, kinetic, and muscle activation pattern (electromyography, EMG) data will be recorded during pre- and post-training and 1 month follow-up evaluations.
Baseline evaluation:
- The participant will put on tight-fitting shorts and shirt. Hair ties will be donned to maintain clear lines of sight from cameras to markers.
- Overground gait assessment: Participants will walk at their self-selected and maximal walking speeds along an instrumented treadmill. Vertical ground reaction force will be recorded to characterize limb loading. Two familiarization trials will be provided and a safety belt will be worn by all participants. A study team member will walk alongside the participant to provide assistance if needed for safety.
- A study team member will place surface electrodes over the participants' gluteus medius (GM), tensor fasciae latae (TFL), and (Vastus lateralis) VL muscles using a wireless EMG system (Delsys Inc., Natick, MA).
- Participants will then perform the maximal voluntary isometric contraction (MVIC) test: During MVIC, a study team member will assess participants' maximal voluntary isometric knee extension and hip abduction torques with a dynamometer. Testing will begin with the less affected lower limb, followed immediately by the affected lower limb for participants with stroke. During knee extension MVIC, the participant will sit upright (85° from horizontal) with the lower leg strapped to the knee testing apparatus at a 60-degree knee flexion angle. The upper leg and torso will be stabilized with Velcro straps and a safety belt. Participants will be instructed to relax the opposite lower limb and rest their hands in their lap. During hip abduction MVIC, a marker will be placed to approximate the location of the hip center of rotation and the participant will be instructed to align the marker with the axis of motion of the dynamometer during standing. The test limb will be strapped to the Biodex input arm, with the lateral thigh pad just proximal to the knee. Hip abduction MVIC will be performed at a hip angle of 15° of abduction (Johnson et al. 2004). Each participant will be asked to push against the lateral thigh pad as hard and fast as they can. For both knee and Hip MVIC tests, 2 submaximal practice trials will be provided. A tester will stand beside the participant to encourage maximal efforts and to monitor alignment and correct movement execution. Two MVIC trials will be collected for each joint.
- Following the MVIC test, the participant will put on a safety harness with the assistance of the research team. Approximately 39 reflective markers will be attached to target locations on the participant's whole body (the head, arms, wrists, hands, trunk, pelvis, legs and feet) according to the Vicon Full-Body Plug-In Gait Model.
- Treadmill Gait Assessment: the participant will walk with their self-selected comfortable speed (SS) and maximal speed (MS) on a treadmill (Motek Inc., Columbus,OH) located in the Movement and Cognitive Rehabilitation Science core lab (BEL530). SS and MS will be determined by gradually increasing and decreasing the treadmill speed to ensure that each walking speed is identified by the participant. A 1-minute familiarization duration will be provided for each speed. Two 30-second baseline walking trials will be recorded for each walking speed. A handrail with a pressure sensing pad is located on the side of the treadmill. Participants will be instructed to only use the handrail if necessary for safety. Participants will wear a safety harness with no body weight support. Body segment position data will be recorded using a 10-camera motion capture system (Vicon-USA, Denver, CO). The motion capture cameras only record the marker trajectories and therefore this video recording contains no facial recognition information that can be used to identify the participant. Ground reaction forces will be captured by the instrumented split-belt treadmill (Motek Inc., Columbus, OH).
Testing will take approximately 3 hours.
Participants with stroke will then complete a 6-week gait training and a post-training and a 1-month follow up evaluation.
Participants will perform Treadmill and Overground Gait Assessments (described previously in Baseline Evaluation) after training and at 1-month follow-up. Post-training and follow-up testing sessions will be conducted a day and 1-month following the last training session, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOW | Experimental | Behavioral: Treadmill Oscillation WalkingTreadmill Oscillation Walking training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hemiparesis as a result of a stroke greater than 6 months previous to the study;
- A single cortical or subcortical stroke
- Able to walk 10 meters with or without a walking aid
- Able to stand unsupported for 5 minutes
- Sufficient cognitive function to follow instruction and communicate with the investigators.
Key exclusion criteria (13 listed)
- Medical condition precluding participant in regular exercise, such as acute cardiac or respiratory conditions limiting activity and other health conditions significantly impacting the ability to walk beyond the effects of the stroke, such as other neurological conditions or peripheral neuropathies;
- Bilateral stroke or a previous stroke in the contralateral hemisphere;
- Had a history of multiple strokes;
- Cerebellar stroke;
- Lower extremity joint replacement;
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 |
|---|---|---|
| Treadmill Oscillation WalkingEach participant with stroke will partake in 18 training sessions. Training sessions will be for one hour three times a week for 6 weeks. During training, participants will walk at their self-selected walking speed on the treadmill that moves side-to-side for 1 cm in a sinusoidal pattern. The sinusoidal oscillation frequency will match each participant's natural stride frequency calculated from baseline evaluation. Subjects will be instructed to respond naturally and maintain continuous walking. Participants will wear a safety harness with no body weight support. For each training session, six 6-minute bouts of treadmill oscillation trials will be performed (Hsiao et al. 2016) and rest period will be provided between bouts. Because lower extremity muscle activity increases with increasing oscillation frequency, the treadmill oscillation frequency will be increased by 5% each week to continue to drive progressive adaptive changes (25% over 6 weeks) (Pohl et al. 2002). | Behavioural | TOW |
Primary outcome
Peak Vertical Ground Reaction Force in the Paretic Limb During Walking
Time frame: pre-training, within one week after training completion (week 7)
changes in peak vertical ground reaction force from pre-training to post-training were calculated
Self Selected Walking Speed From Pre to Post Training During 10 Meter Walk Test
Time frame: pre-training, within one week after training completion (week 7)
changes in self-selected walking speed from pre-training to post-training were calculated
Self-efficacy
Time frame: pre-training, within one week after training completion (week 7)
changes in self-perceived balance and mobility ability from pre-training to post-training were calculated. It measures self-perceived balance, transfers, and walking abilities (e.g., standing unsupported, climbing stairs, walking fast).The range of the scale is 0 - 45, with higher values indicate higher self-perceived function.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15083435Johnson ME, Mille ML, Martinez KM, Crombie G, Rogers MW. Age-related changes in hip abductor and adductor joint torques. Arch Phys Med Rehabil. 2004 Apr;85(4):593-7. doi: 10.1016/j.apmr.2003.07.022.
- Background: PubMed 26721869Hsiao H, Awad LN, Palmer JA, Higginson JS, Binder-Macleod SA. Contribution of Paretic and Nonparetic Limb Peak Propulsive Forces to Changes in Walking Speed in Individuals Poststroke. Neurorehabil Neural Repair. 2016 Sep;30(8):743-52. doi: 10.1177/1545968315624780. Epub 2015 Dec 31.
- Background: PubMed 11823669Pohl M, Mehrholz J, Ritschel C, Ruckriem S. Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. Stroke. 2002 Feb;33(2):553-8. doi: 10.1161/hs0202.102365.
- Individual participant dataSharing planned: Yes. This proposed research will include data from approximately 15 subjects regarding their walking mechanics. Muscle activation patterns, body movement, and force production data will be recorded. Only de-identified data will be shared for research purposes.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Oscillation Walking in people with Treadmill Walking, run by University of Texas at Austin 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 6 inclusion and 13 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 26 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 26 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?
Peak Vertical Ground Reaction Force in the Paretic Limb During Walking (time frame: pre-training, within one week after training completion (week 7)). The study lists 3 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 NCT05541705, which also lists 3 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 26 Oct 2026.