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Prosthesis

Powered Knee-Ankle Prosthesis and Microprocessor Knee Prosthesis for Transfemoral Amputee

N/A

Waitlist Available

Led By Arun Jayaraman, PT, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral transfemoral level limb loss or limb difference

K2/K3/K4 level ambulators

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1 (pre-assessment); week 2 (training assessment); week 3 (training assessment); week 6-7 (post-training assessments); weeks 21-22 (post-training assessment)

Awards & highlights

Study Summary

This trial will test how well new powered prosthetic devices work for people with transfemoral amputations. The goal is to see if they can significantly improve functionality and quality of life.

Who is the study for?

This trial is for individuals with one leg amputated above the knee who are currently using a microprocessor knee prosthesis and can walk at various speeds. They must be under 250 lbs, not pregnant, mentally fit to consent and follow instructions, and free of other serious health issues that could affect participation.Check my eligibility

What is being tested?

The study is testing the effectiveness of a new powered prosthetic leg called Vanderbilt Powered Knee-Ankle Prosthesis compared to standard microprocessor knees in improving mobility and social interaction for people with above-knee amputations.See study design

What are the potential side effects?

While not typical side effects as seen with medications, participants may experience discomfort or require time to adjust to the new prosthesis. There might also be risks associated with increased activity levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have lost one leg at or above the knee.

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I can walk with little to no assistance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 (pre-assessment); week 2 (training assessment); week 3 (training assessment); week 6-7 (post-training assessments); weeks 21-22 (post-training assessment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 (pre-assessment); week 2 (training assessment); week 3 (training assessment); week 6-7 (post-training assessments); weeks 21-22 (post-training assessment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 (pre-assessment); week 2 (training assessment); week 3 (training assessment); week 6-7 (post-training assessments); weeks 21-22 (post-training assessment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change between devices of the Modified Graded Treadmill Test

Change in Biomechanical Assessment [Gait Parameters and Surface Electromyography (EMG) Activation] Between Devices

Secondary outcome measures

4-Square Step Test

5 Times Sit to Stand Test (5XSST)

6 Minute Walk Test (6MWT) with COSMED K4B2 Metabolic unit

+11 more

Other outcome measures

Borg Rate of Perceived Exertion (Borg RPE)

Modified Falls Efficacy Scale (mFES)

Numerical Pain Rating Scale (NPRS)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vanderbilt Powered Knee-Ankle ProsthesisExperimental Treatment1 Intervention

Upon screening and enrollment participants return for up to 8 prosthetic fitting sessions and up to 12 physical therapy training sessions using the Vanderbilt Powered Knee-Ankle (PKA) Prosthesis. Once training is complete participants will return for up to 6 post-training assessment sessions using the Vanderbilt Powered Knee-Ankle (PKA) Prosthesis. The device participants begin with will be randomly selected but there will be an equal opportunity to train with both devices. In between training, there will be an 8 week "wash out period" to allow normalization to use of the device, reducing carryover effects. After wash-out period protocol will be repeated with second device.

Group II: Microprocessor (MP) Knee ProsthesisActive Control1 Intervention

Upon screening and enrollment participants return for up to 8 prosthetic fitting sessions and up to 12 physical therapy training sessions using their own Microprocessor (MP) Knee Prosthesis. Once training is complete participants will return for up to 6 post-training assessment sessions using the Microprocessor (MP) Knee Prosthesis. The device participants begin with will be randomly selected but there will be an equal opportunity to train with both devices. In between training, there will be an 8 week "wash out period" to allow normalization to use of the device, reducing carryover effects. After wash-out period protocol will be repeated with second device.

0 / 2Eligibility criteria met