NCT06700668
Active, not recruiting
Not Applicable
Active Knee Prosthesis Study
ConditionsTransfemoral Amputation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transfemoral Amputation
- Sponsor
- Massachusetts Institute of Technology
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Metabolic cost
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
The purpose of the study is to investigate the clinical and functional outcomes of a powered knee prosthesis for people with a transfemoral amputation in the domain of gait, free space control, and embodiment
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female age 22-
- •The patient must have a unilateral transfemoral amputation .
- •The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
- •The patient must have adequate socket to support the device.
Exclusion Criteria
- •Women who are pregnant.
- •Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI \>40, etc.).
Outcomes
Primary Outcomes
Metabolic cost
Time Frame: An average of 2 sessions in the span of 1 week
Effort of participants' walking measured via metabolic cost, which is measured using an mask that measures the Oxygen and Carbon dioxide levels.
Secondary Outcomes
- Ground reaction force(An average of 2 sessions in the span of 1 week)
- Gait kinematics(An average of 2 sessions in the span of 1 week)
Study Sites (1)
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