Active — Not RecruitingNot Applicable

Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social Interaction

United States15 participantsStarted 2016-12

Plain-language summary

The overall goal of this research is to determine the efficacy of new powered prosthetic devices for individuals with transfemoral amputations. The anticipation is that this will be a high-impact technological intervention with the potential to restore significant functionality to individuals with lower limb amputation and transform the field of lower limb prosthetics. The objective of the proposed clinical trial is to fully evaluate the biomechanical and energetic effects of using PKA prosthesis and quantify functional performance and quality of life changes.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Unilateral transfemoral level limb loss or limb difference * K2/K3/K4 level ambulators * Required to use a microprocessor knee on their prosthesis Exclusion Criteria: * Over 250 lbs body weight * Inactive, physically unfit * Cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments * Pregnant women * Co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)

What they're measuring

Change between devices of the Modified Graded Treadmill Test

Timeframe: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

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

Timeframe: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

Trial details

NCT IDNCT03204513

SponsorShirley Ryan AbilityLab

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Transfemoral Amputees trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change between devices of the Modified Graded Treadmill Test

Timeframe: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

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

Timeframe: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)