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

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ClinicalTrials.gov Identifier: NCT03974945
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment
Amputation Device: Passive-elastic prosthetic foot Device: Powered ankle-foot prosthesis

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Can Sensory Feedback Training Improve the Biomechanical and MetabolicEffects of Using Passive or Powered Lower Limb Prostheses During Walking forVeterans With Transtibial Amputations?
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

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.
Device: 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.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Biospecimen Retention:   None Retained
none retained


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974945


Contacts
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Contact: Alena Grabowski, PhD BA (720) 435-4270 Alena.Grabowski@va.gov

Locations
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United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO Recruiting
Aurora, Colorado, United States, 80045
Contact: Alena Grabowski, PhD BA    720-435-4270    Alena.Grabowski@va.gov   
Principal Investigator: Alena Grabowski, PhD BA         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Alena Grabowski, PhD BA Rocky Mountain Regional VA Medical Center, Aurora, CO

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03974945     History of Changes
Other Study ID Numbers: A2943-R
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
Rehabilitation