Transfemoral Amputation
Conditions
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
Interventions
DEVICEMIT Powered Knee
MIT powered knee prosthesis developed by the MIT Biomechatronics Group.
Sponsors
U.S. Army Medical Research and Development Command
Massachusetts Institute of Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed