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Prosthesis

Powered Prosthetics for Knee Amputations

N/A
Recruiting
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-95
A unilateral transfemoral amputation
Must not have
Weight greater than 250 pounds
Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38
Awards & highlights

Summary

"This trial aims to study how providing power at the knee or ankle, or both, affects the walking ability of K2 level transfemoral amputees. They will be testing different prosthetic devices

Who is the study for?
This trial is for K2-level transfemoral amputees, meaning individuals who have had an above-knee amputation and can walk with a cane or crutches. The study aims to understand the impact of powered prosthetic knees and ankles on their walking ability.
What is being tested?
The study compares different combinations of prosthetic limbs: a passive microprocessor knee (Ottobock CLeg4) with either an Ottobock foot or polycentric ankle, and a powered knee (SRALAB Hybrid Knee) with either a passive or polycentric powered ankle.
What are the potential side effects?
Since this trial involves mechanical prosthetics rather than drugs, traditional side effects are not applicable. However, participants may experience discomfort or require time to adjust to the new prosthetics during ambulation tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 95 years old.
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I have had one leg amputated above the knee.
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I can walk 55 yards on my own with a prosthesis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I weigh more than 250 pounds.
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I understand and can follow the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38
This trial's timeline: 3 weeks for screening, Varies for treatment, and completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amputee Mobility Predictor with Prosthesis (AMPRO) score
Secondary outcome measures
6 Minute Walk Test (6MWT)
Four Square Step Test (FSST)
Metabolic Testing
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB footExperimental Treatment2 Interventions
During this arm, participants will receive intensive clinical training with the SRALAB Hybrid knee + Polycentric Ankle twice per week over 8 weeks, lasting 2-3 hours. Training will include patient-driven therapy to achieve participants' individual therapy goals, functional mobility and community skills. At the end of the 8-week training period, subjects will complete the same set of functional outcome measures, biomechanical and metabolic assessments in previous arms. To complete this arm, participants will again complete training and outcome measures with the Ottobock Cleg4/Ottobock or their clinically prescribed microprocessor knee unit/foot over 3 visits.
Group II: Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive AnkleExperimental Treatment2 Interventions
For this arm, transfemoral amputees will participate in an AB/BA randomized crossover study. Before each arm of the cross-over, baseline data will be taken with the Ottobock Cleg 4/Ottobock foot or their clinically prescribed microprocessor knee unit/foot. Condition A is CLeg + Polycentric Ankle Condition B is SRALab Hybrid knee + Passive Ankle Subjects will participate in 2 sessions over 2 weeks, each lasting 2-3 hours to have the device tuned for the specific condition (A or B). On the third week, they will participate in 2 visits to complete functional outcome measures, biomechanical and metabolic assessments. They will then switch conditions, and repeat the protocol for the second condition. There will not be a washout period between conditions, but subjects will complete outcome measures with the Ottobock Cleg 4/Ottobock foot or their clinically prescribed microprocessor knee unit/foot prior to each arm of the crossover to obtain baseline data.
Group III: Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric AnkleActive Control2 Interventions
Participant is fit with the commercially available device (Ottobock Cleg 4/Ottobock foot), they will receive standard of care clinical training for 3-4 sessions over 4 weeks, plus 1 session for outcome assessments. Participant is then fit with the SRALAB Hybrid knee and SRALAB Polycentric Ankle prosthesis, they again will receive clinical training for 3-4 sessions over 4 weeks, plus 1 session for outcome assessments.

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Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
204 Previous Clinical Trials
17,819 Total Patients Enrolled
~13 spots leftby Jun 2028
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