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Clinical Trials/NCT06700668
NCT06700668
Active, not recruiting
Not Applicable

Active Knee Prosthesis Study

Massachusetts Institute of Technology1 site in 1 country7 target enrollmentApril 17, 2008

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

Registry
clinicaltrials.gov
Start Date
April 17, 2008
End Date
July 17, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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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