Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT06433648
Status
Recruiting
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Conditions

  • Amputation
  • Amputation of Knee
  • Amputation, Traumatic
  • Amputation; Traumatic, Limb

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Ottobock CLeg4 + Ottobock foot — DEVICE
    Commercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot.
  • SRALAB Hybrid Knee + Polycentric Ankle — DEVICE
    Experimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle.
  • SRALAB Hybrid Knee + Passive Ankle — DEVICE
    Experimental powered prosthesis: SRALAB Hybrid Knee and passive ankle.
  • Ottobock CLeg 4 + Polycentric Ankle — DEVICE
    Commercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle.

Study Details

The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees. Aim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle. Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only. Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle). Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.

Key Dates

Start date
May 1, 2023
Status verified
May 2024
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle
    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.
  • Experimental: Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle
    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.
  • Experimental: Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot
    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.

Primary Outcome Measure

Amputee Mobility Predictor with Prosthesis (AMPRO) score [ Time Frame: Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611
Suzanne Finucane, MS, PTA
[email protected]
312-238-0937
Levi Hargrove, PhD
[email protected]
312-238-2080
Levi Hargrove, PhD (PRINCIPAL_INVESTIGATOR)

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