N/A
N=12
Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?
Amputation
Bottom Line
View on ClinicalTrials.gov: NCT03974945 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Affected Leg Peak Propulsive Horizontal Ground Reaction Force — 0.151; 0.145; 0.166; 0.150 proportion of body weight
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Passive-elastic prosthetic foot (Device); Powered ankle-foot prosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Affected Leg Peak Propulsive Horizontal Ground Reaction Force |
0.151; 0.145; 0.166; 0.150; 0.175; 0.147 | — |
| PRIMARY Net Metabolic Power |
2.967; 3.141; 3.020; 3.338; 3.124; 3.478 | — |
| PRIMARY Trailing Affected Leg Positive Work |
9.859; 10.321; 10.773; 10.212; 11.203; 10.319 | — |
| PRIMARY Leading Unaffected Leg Negative Work |
-15.373; -14.438; -15.981; -14.363; -17.781; -14.018 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03974945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.