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

July 5, 2023 updated by: VA Office of Research and Development

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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contact:
        • Principal Investigator:
          • Alena Grabowski, PhD BA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motion will be measured using 3D motion capture
Time Frame: Through study completion, an average of 1 year
The investigators will measure motion (rad) while participants walk using a passive elastic and battery-powered ankle-foot prosthesis and are given different visual feedback targets of peak propulsive force.
Through study completion, an average of 1 year
Forces will be measured using a force-measuring treadmill
Time Frame: Through study completion, an average of 1 year
The investigators will measure forces (N) while participants walk using a passive elastic and battery-powered ankle-foot prosthesis and are given different visual feedback targets of peak propulsive force.
Through study completion, an average of 1 year
Rates of oxygen consumption and carbon dioxide production will be measured using indirect calorimetry to calculate metabolic power
Time Frame: Through study completion, an average of 1 year
The investigators will measure metabolic rates and calculate metabolic power (W/kg) while participants walk using a passive elastic and battery-powered ankle-foot prosthesis and are given different visual feedback targets of peak propulsive force.
Through study completion, an average of 1 year
Muscle activity will be measured using wireless surface electromyography (sEMG)
Time Frame: Through study completion, an average of 1 year
The investigators will measure muscle activity (V) while participants walk using a passive elastic and battery-powered ankle-foot prosthesis and are given different visual feedback targets of peak propulsive force.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alena Grabowski, PhD BA, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Estimated)

May 14, 2024

Study Completion (Estimated)

May 14, 2024

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A2943-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amputation

Clinical Trials on Passive-elastic prosthetic foot

3
Subscribe