Recruiting

Observational Study

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT06433648

Conditions

Amputation

Amputation, Traumatic

Amputation of Knee

Amputation; Traumatic, Limb

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ottobock CLeg4 + Ottobock foot

SRALAB Hybrid Knee + Polycentric Ankle

SRALAB Hybrid Knee + Passive Ankle

Ottobock CLeg 4 + Polycentric Ankle

Study Details

Brief summary:

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.

Conditions

Amputation

Amputation, Traumatic

Amputation of Knee

Amputation; Traumatic, Limb

Study ID

NCT06433648

Start date

May 1, 2023

Status verified date

May, 2024

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 18-95
  • A unilateral transfemoral amputation
  • At least 6 months since definitive prosthesis fitting
  • Able to walk 50 meters (55 yards) with a prosthesis without the assistance of another person.
  • Medically cleared by physician to participate in study
  • English speaking

Exclusion Criteria:

  • Weight greater than 250 pounds
  • Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
  • Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
  • Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Ottobock CLeg4 + Ottobock foot

Commercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot.

SRALAB Hybrid Knee + Polycentric Ankle

Experimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle.

SRALAB Hybrid Knee + Passive Ankle

Experimental powered prosthesis: SRALAB Hybrid Knee and passive ankle.

Ottobock CLeg 4 + Polycentric Ankle

Commercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle.

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 and Locations

Central contacts

Suzanne Finucane, MS, PTA

312-238-0937sfinucane@sralab.org

Levi Hargrove, PhD

312-238-2080lhargrove@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Suzanne Finucane, MS, PTA

312-238-0937sfinucane@sralab.org

Levi Hargrove, PhD

312-238-2080lhargrove@sralab.org

Principal Investigator:

Levi Hargrove, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

May 30, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2024-05-30.