Active Knee Prosthesis Study

Not Applicable

Active, not recruiting

• Conditions: Transfemoral Amputation

• Registration Number: NCT06700668
• Lead Sponsor: Massachusetts Institute of Technology

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-17
• Status Verified: 2024-11
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-07-17
• Study Completion: 2025-07-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Male or Female age 22-65.
• 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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Metabolic cost	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 Outcome Measures

Name	Time	Method
Gait kinematics	An average of 2 sessions in the span of 1 week	Motion capture data will be collected using a validated system (e.g., Vicon, or similar motion capture software). Reflective markers will be placed on anatomical landmarks following a standard gait model. Kinematic measures, including joint angles (hip, knee, and ankle), step length, stride length, cadence, and walking speed, will be derived.
Ground reaction force	An average of 2 sessions in the span of 1 week	Ground reaction forces will be measured via force plates on the ground.

Trial Locations

Locations (1)

MIT Media Lab; 🇺🇸 Cambridge, Massachusetts, United States