AmputationNCT03974945
Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?
An observational study of Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Previous studies suggest that Veterans with below the knee amputation using passive-elastic or powered prostheses have impaired physical function, which could increase the risk of osteoarthritis, leg/back pain, and diabetes/obesity. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Passive-elastic prosthetic foot and Powered ankle-foot prosthesis
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 14 May 2024
- Phase
- Observational
- 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 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will recruit 30 subjects with unilateral transtibial amputations from the VA Jewell Clinic, locally, and nationally.
Who may be able to join
- One amputation below the knee
- At least 1 year of experience using a prosthesis
- No current problems with the prosthesis or residual limb
- At or above a K3 Medicare Functional Classification Level
Who cannot join
- Poor general health
- Difficulty with mobility
- Problems with balance or dizziness
- Current serious musculoskeletal injury besides that associated with an amputation
- Cardiovascular, pulmonary, or neurological disease or disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
About this study
Official title: Can Sensory Feedback Training Improve the Biomechanical and Metabolic Effects of Using Passive or Powered Lower Limb Prostheses During Walking for Veterans With Transtibial Amputations?
Previous studies suggest that Veterans with below the knee amputation using passive-elastic or powered prostheses have impaired physical function, which could increase the risk of osteoarthritis, leg/back pain, and diabetes/obesity. Utilization of rehabilitation strategies/techniques such as real-time visual feedback training could restore physical function, increase physical activity, and reduce injury risk. The investigators will systematically determine the effects of using real-time visual feedback training of peak propulsive (push-off) force during walking while Veterans with below the knee amputations use a passive-elastic and battery-powered prosthesis. Similar to previous studies of non-amputee older (>65 years) and post-stroke adults, use of real-time visual feedback training of propulsive force will likely improve walking function in Veterans with amputations. Such training presents a promising rehabilitation strategy that could reduce comorbidities, while improving quality of life, comfort, and physical function, and advancing rehabilitation research and prosthetic development.
Read the detailed description
Due to the functional impairments caused by a lower limb amputation, it is essential to determine the benefits of rehabilitation strategies such as real-time visual feedback training. Such training could allow Veterans with transtibial amputations (TTAs) to better utilize their prostheses and regain the greatest possible level of function. It is not clear how much the prosthetic device (passive-elastic prosthetic foot versus battery-powered ankle-foot prosthesis) and/or the user's response to the prosthesis contribute to the biomechanical and metabolic effects of using these prostheses during walking. Better use of a prosthesis due to targeted real-time visual feedback training could enhance rehabilitation, improve function and reduce asymmetric biomechanics, which in turn could reduce common comorbidities such as osteoarthritis, leg and back pain, and indirectly, diabetes in Veterans with TTAs. The purpose of the proposed project is to systematically establish the metabolic and biomechanical effects of targeted real-time visual feedback training of peak propulsive ground reaction force (GRF) on the biomechanics, metabolic costs, and muscle activity of Veterans with TTAs using their own passive-elastic prosthetic foot and a battery-powered ankle-foot prosthesis. The results of the investigators' research could enhance the use of prosthetic technology to improve the rehabilitation and function of Veterans with lower limb amputations.
Previous studies suggest that use of passive-elastic and/or powered ankle-foot prostheses may not optimize the function of Veterans with TTAs during walking. Targeted, real-time visual feedback training of peak propulsive ground reaction forces increased propulsion and improved walking function in older (>65 years) and post-stroke adults, who typically have impaired ankle power. To the investigators' knowledge, no research has addressed how visual feedback of peak propulsive force affects the use of passive-elastic or powered ankle-foot prostheses by people with TTAs. In the proposed research, the investigators will determine the underlying metabolic costs, biomechanics, stability, and muscle activity resulting from targeted real-time visual feedback training of peak propulsive force to identify how Veterans with a TTA benefit from more effective use of a passive-elastic prosthesis and/or a battery-powered ankle-foot prosthesis and to determine if the addition of mechanical power provided by a battery-powered ankle-foot prosthesis can further enhance the function of Veterans with unilateral TTAs during walking. 30 Veterans with unilateral TTAs will use their own passive-elastic prosthesis both with and without visual feedback training during level-ground walking, while the investigators measure their metabolic costs and biomechanics. Then, they will use a powered ankle-foot prosthesis (emPOWER, BiONX, Ottobock) both with and without visual feedback training during level-ground walking, while the investigators measure their metabolic costs and biomechanics. With each prosthesis, subjects will walk at 1.25 m/s on a dual-belt force-measuring treadmill 1) with no visual feedback, and then with real-time visual feedback of: 2) peak propulsive force from the "no feedback" condition, 3) +20% greater peak propulsive force, and 4) +40% greater peak propulsive force. During these visual feedback trials, the investigators will ask subjects to match the peak propulsive force displayed on a computer screen with their affected leg. The investigators will also ask subjects to: 5) match symmetric visual feedback of the peak propulsive force from both legs. The investigators will determine if Veterans with TTAs utilizing real-time visual feedback training of peak propulsive force can improve metabolic costs, biomechanical symmetry, and dynamic stability/balance, while using their own passive-elastic prosthesis or a powered ankle-foot prosthesis. The investigators will also establish if Veterans with TTAs can retain the metabolic and biomechanical benefits elicited by real-time visual feedback training once that feedback is removed. Results from the proposed project will be used to inform rehabilitation strategies and prosthetic design, which could ultimately improve health, maximize function, and improve quality of life for Veterans with TTAs.
- Conditions
- Amputation
- Being tested
- Passive-elastic prosthetic foot, Powered ankle-foot prosthesis
- Keywords
- Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive-elastic prosthetic footDevice
The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects walk using their own passive-elastic prosthesis with and without visual feedback of peak propulsive force targets.
Powered ankle-foot prosthesisDevice
The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects walk using a battery-powered ankle-foot prosthesis with and without visual feedback of peak propulsive force targets.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Transtibial Amputation | The investigators will recruit participants with unilateral transtibial amputations who are at or above a K3 Medicare functional classification level (MFCL), and 18-60 years old. A K3 MFCL means that a person has the ability or potential for ambulation with variable cadence. A person at K3 MFCL is a typical community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic or exercise activity that demands prosthetic use beyond simple locomotion. Receives: Device: Passive-elastic prosthetic foot; Device: Powered ankle-foot prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affected Leg Peak Propulsive Horizontal Ground Reaction Force
The investigators measured peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline hGRFpeak and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak. Thus, participants performed 9 trials per prosthesis.
Measured: 18 trials that are 5 minutes in length
Net Metabolic Power
The investigators measured net metabolic power while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak. Thus, participants performed 9 trials per prosthesis.
Measured: 18 trials that are 5 minutes in length
Trailing Affected Leg Positive Work
The investigators measured ground reaction forces and calculated individual leg work during step to step transitions while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak.
Measured: 18 trials that are 5 minutes in length
Leading Unaffected Leg Negative Work
The investigators measured ground reaction forces and calculated individual leg work during step to step transitions while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak.
Measured: 18 trials that are 5 minutes in length
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Aug 2019
- Primary completion14 May 2024
- Study completion14 May 2024
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.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alena Grabowski, PhD BA, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974945
- Sponsor's protocol ID
- A2943-R
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2019
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Sensory Feedback Training Improve the Biomechanical and Metabolic Effects of Using Passive or Powered Lower Limb Prostheses During Walking for Veterans With Transtibial Amputations?
- ClinicalTrials.gov ID
- NCT03974945
- Acronym / sponsor ID
- A2943-R
- Conditions
- Amputation
- Keywords
- Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies suggest that Veterans with below the knee amputation using passive-elastic or powered prostheses have impaired physical function, which could increase the risk of osteoarthritis, leg/back pain, and diabetes/obesity. Utilization of rehabilitation strategies/techniques such as real-time visual feedback training could restore physical function, increase physical activity, and reduce injury risk. The investigators will systematically determine the effects of using real-time visual feedback training of peak propulsive (push-off) force during walking while Veterans with below the knee amputations use a passive-elastic and battery-powered prosthesis. Similar to previous studies of non-amputee older (>65 years) and post-stroke adults, use of real-time visual feedback training of propulsive force will likely improve walking function in Veterans with amputations. Such training presents a promising rehabilitation strategy that could reduce comorbidities, while improving quality of life, comfort, and physical function, and advancing rehabilitation research and prosthetic development.
Detailed description
Due to the functional impairments caused by a lower limb amputation, it is essential to determine the benefits of rehabilitation strategies such as real-time visual feedback training. Such training could allow Veterans with transtibial amputations (TTAs) to better utilize their prostheses and regain the greatest possible level of function. It is not clear how much the prosthetic device (passive-elastic prosthetic foot versus battery-powered ankle-foot prosthesis) and/or the user's response to the prosthesis contribute to the biomechanical and metabolic effects of using these prostheses during walking. Better use of a prosthesis due to targeted real-time visual feedback training could enhance rehabilitation, improve function and reduce asymmetric biomechanics, which in turn could reduce common comorbidities such as osteoarthritis, leg and back pain, and indirectly, diabetes in Veterans with TTAs. The purpose of the proposed project is to systematically establish the metabolic and biomechanical effects of targeted real-time visual feedback training of peak propulsive ground reaction force (GRF) on the biomechanics, metabolic costs, and muscle activity of Veterans with TTAs using their own passive-elastic prosthetic foot and a battery-powered ankle-foot prosthesis. The results of the investigators' research could enhance the use of prosthetic technology to improve the rehabilitation and function of Veterans with lower limb amputations.
Previous studies suggest that use of passive-elastic and/or powered ankle-foot prostheses may not optimize the function of Veterans with TTAs during walking. Targeted, real-time visual feedback training of peak propulsive ground reaction forces increased propulsion and improved walking function in older (>65 years) and post-stroke adults, who typically have impaired ankle power. To the investigators' knowledge, no research has addressed how visual feedback of peak propulsive force affects the use of passive-elastic or powered ankle-foot prostheses by people with TTAs. In the proposed research, the investigators will determine the underlying metabolic costs, biomechanics, stability, and muscle activity resulting from targeted real-time visual feedback training of peak propulsive force to identify how Veterans with a TTA benefit from more effective use of a passive-elastic prosthesis and/or a battery-powered ankle-foot prosthesis and to determine if the addition of mechanical power provided by a battery-powered ankle-foot prosthesis can further enhance the function of Veterans with unilateral TTAs during walking. 30 Veterans with unilateral TTAs will use their own passive-elastic prosthesis both with and without visual feedback training during level-ground walking, while the investigators measure their metabolic costs and biomechanics. Then, they will use a powered ankle-foot prosthesis (emPOWER, BiONX, Ottobock) both with and without visual feedback training during level-ground walking, while the investigators measure their metabolic costs and biomechanics. With each prosthesis, subjects will walk at 1.25 m/s on a dual-belt force-measuring treadmill 1) with no visual feedback, and then with real-time visual feedback of: 2) peak propulsive force from the "no feedback" condition, 3) +20% greater peak propulsive force, and 4) +40% greater peak propulsive force. During these visual feedback trials, the investigators will ask subjects to match the peak propulsive force displayed on a computer screen with their affected leg. The investigators will also ask subjects to: 5) match symmetric visual feedback of the peak propulsive force from both legs. The investigators will determine if Veterans with TTAs utilizing real-time visual feedback training of peak propulsive force can improve metabolic costs, biomechanical symmetry, and dynamic stability/balance, while using their own passive-elastic prosthesis or a powered ankle-foot prosthesis. The investigators will also establish if Veterans with TTAs can retain the metabolic and biomechanical benefits elicited by real-time visual feedback training once that feedback is removed. Results from the proposed project will be used to inform rehabilitation strategies and prosthetic design, which could ultimately improve health, maximize function, and improve quality of life for Veterans with TTAs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Transtibial Amputation | – | Device: Passive-elastic prosthetic foot, Device: Powered ankle-foot prosthesisThe investigators will recruit participants with unilateral transtibial amputations who are at or above a K3 Medicare functional classification level (MFCL), and 18-60 years old. A K3 MFCL means that a person has the ability or potential for ambulation with variable cadence. A person at K3 MFCL is a typical community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic or exercise activity that demands prosthetic use beyond simple locomotion. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will recruit 30 subjects with unilateral transtibial amputations from the VA Jewell Clinic, locally, and nationally.
Key inclusion criteria (4 listed)
- One amputation below the knee
- At least 1 year of experience using a prosthesis
- No current problems with the prosthesis or residual limb
- At or above a K3 Medicare Functional Classification Level
Key exclusion criteria (5 listed)
- Poor general health
- Difficulty with mobility
- Problems with balance or dizziness
- Current serious musculoskeletal injury besides that associated with an amputation
- Cardiovascular, pulmonary, or neurological disease or disorder
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 |
|---|---|---|
| Passive-elastic prosthetic footThe investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects walk using their own passive-elastic prosthesis with and without visual feedback of peak propulsive force targets. | Device | Participants with Transtibial Amputation |
| Powered ankle-foot prosthesisThe investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects walk using a battery-powered ankle-foot prosthesis with and without visual feedback of peak propulsive force targets. | Device | Participants with Transtibial Amputation |
Primary outcome
Affected Leg Peak Propulsive Horizontal Ground Reaction Force
Time frame: 18 trials that are 5 minutes in length
The investigators measured peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline hGRFpeak and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak. Thus, participants performed 9 trials per prosthesis.
Net Metabolic Power
Time frame: 18 trials that are 5 minutes in length
The investigators measured net metabolic power while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak. Thus, participants performed 9 trials per prosthesis.
Trailing Affected Leg Positive Work
Time frame: 18 trials that are 5 minutes in length
The investigators measured ground reaction forces and calculated individual leg work during step to step transitions while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak.
Leading Unaffected Leg Negative Work
Time frame: 18 trials that are 5 minutes in length
The investigators measured ground reaction forces and calculated individual leg work during step to step transitions while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alena Grabowski, PhD BA principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by VA Office of Research and Development 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 5 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 15 Jul 2025. 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 15 Jul 2025). 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?
Affected Leg Peak Propulsive Horizontal Ground Reaction Force (time frame: 18 trials that are 5 minutes in length). 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?
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 15 Jul 2025; AzTrials last refreshed its copy on 27 Oct 2026.