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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation

NCT03995238

Transtibial Amputation Peripheral Artery Disease Diabetes Mellitus

RECRUITING NA

Walking Exercise Sustainability Through Telehealth for Veterans With Lower-limb Amputation

NCT05412550

Lower-Limb Amputation

RECRUITING NA

Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Patients With Step Length Asymmetry After Stroke

NCT02207933

Stroke Hemiplegic Gait

COMPLETED NA

Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke

NCT04637737

Stroke

UNKNOWN NA

The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation

NCT01225432

Elevated Metabolic Cost

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Amputation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Passive-elastic prosthetic foot

Intervention Type 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.

Powered ankle-foot prosthesis

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Passive-elastic prosthetic foot

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.

Intervention Type DEVICE

Powered ankle-foot prosthesis

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes