Recruiting

Hybrid Prosthetic Leg

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT04038151

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hybrid Leg

Prescribed Passive Prosthesis

Study Details

Brief summary:

The objective of this research is to determine the clinical benefits of an innovative and lightweight powered leg controlled using our intent recognition framework in laboratory and community environments.

Conditions

Amputation

Study ID

NCT04038151

Start date

Dec 1, 2018

Status verified date

May, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A unilateral or bilateral lower limb amputation
  • K2/K3/K4 ambulator with a prosthesis
  • English speaking

Exclusion Criteria:

  • 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

experimental: Condition A: Hybrid Leg

Subject will be trained on use of the experimental device, the Hybrid Leg.

other: Condition B: Passive Leg

Subject will use their currently prescribed home passive prosthesis

Interventions

Hybrid Leg

The Hybrid Knee uses an actively variable transmission in combination of a passive spring/damper system. This allows the motor torque output to be adapted to the requirements of active dynamic tasks - changing the effective transmission ration from zero (fully passive) for level ground walking to a maximum value (fully active) for sit-to-stand transfers. This provides physiological knee torque and speed with a small motor and primary transmission system while also maximizing electrical efficiency, which minimized battery weight. The knee prototype weights 1.7kg. The Semi-active ankle can actively reposition during non-weight bearing phases of gait and uses a non back driveable transmission to maintain its set point during weight bearing activities.

Prescribed Passive Prosthesis

Participants will participate in training sessions of community skills and advanced ambulation training for their home, prescribed passive prosthesis.

Primary outcome measure

  • Average daily number of steps [ Time Frame: 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial ]
  • Average daily number of times subject switches between activities [ Time Frame: 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial ]

Central Contacts and Locations

Central contacts

Suzanne Finucane

312-238-0937sfinucane@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Suzanne Finucane

312-238-0937sfinucane@sralab.org

Principal Investigator:

Levi Hargrove, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

May 17, 2024

Last verified

May, 2024

Keywords

  • Transfemoral Amputation

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 2024-05-17.