Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?

NCT03974945 | Completed Results

• 1 other identifier: A2943-R
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  18 trials that are 5 minutes in length

Study Arms (1)

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.

Device: Passive-elastic prosthetic foot; Device: Powered ankle-foot prosthesis

Interventions

Passive-elastic prosthetic foot DEVICE

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.

Participants with Transtibial Amputation

Powered ankle-foot prosthesis DEVICE

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.

Participants with Transtibial Amputation

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit 30 subjects with unilateral transtibial amputations from the VA Jewell Clinic, locally, and nationally.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: NONE RETAINED

none retained

Results Point of Contact

• Title: Dr. Alena Grabowski
• Organization: Rocky Mountain Regional Department of Veterans Affairs

alena.grabowski@va.gov

303-492-5208

Study Officials

• Alena Grabowski, PhD BA

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: August 1, 2019
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: July 15, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)