Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Energy Storing and Returning Prosthetic Feet in Persons With Unilateral Transtibial Amputation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- Ability Prosthetics and Orthotics, Inc.
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Amputee Mobility Predictor with Prosthesis (AMPPRO)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.
Detailed Description
Recent advancements in microprocessor controlled prosthetic ankle-foot systems have allowed additional functionality for the lower limb amputee, but research into the effectiveness of microprocessor controlled ankle-foot systems has been limited. In this research study, differences in perceived mobility, functional capabilities and gait parameters between energy storing and returning and microprocessor controlled ankle-foot mechanisms will be identified where they exist. Also a comparison of the initial function with a new system compared to the function after a four week accommodation period will provide insight into the time it takes for the prosthesis user to experience a benefit from a microprocessor ankle-foot.
Investigators
Brian Kaluf BSE, CP
Clinical Outcome and Research Director
Ability Prosthetics and Orthotics, Inc.
Eligibility Criteria
Inclusion Criteria
- •Unilateral transtibial amputation
- •Age 18-99 years old
- •Body weight below 275 lbs
- •Non-pregnant
- •English speaking
- •Current user of prosthesis for at least one year
- •Wear time 8 hrs/day or more
- •MFCL ≥ K-3
- •Well-fitting and functioning prosthesis
- •No use of ambulatory aide
Exclusion Criteria
- •Amputation level other than unilateral transtibial
- •Age \<18 or \>99 years old
- •Body weight above 275 lbs
- •Non-English speaking
- •Not current user of prosthesis
- •Less than one year use of prosthesis
- •Wear time less than 8 hr/day
- •MFCL \<K3
- •Poor fitting and functioning prosthesis
- •Indicating that the socket fit is painful, or unacceptable
Outcomes
Primary Outcomes
Amputee Mobility Predictor with Prosthesis (AMPPRO)
Time Frame: Collection at baseline
The AMPPRO is a functional test consisting of 21 tasks that are similar to everyday function to test balance, strength and walking ability
L-Functional Test (L-Test) Baseline
Time Frame: Collection at baseline
The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.
6 minute Timed Walk Test (6m TWT) Baseline
Time Frame: Collection at baseline
The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.
Hill Assessment Index (HAI) Baseline
Time Frame: Collection at baseline
The HAI is a functional test that measures quality of walking up and down a sloped ramp.
5 times Sit-to-Stand (5 times STS) Baseline
Time Frame: Collection at baseline
The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.
Physiological Cost Index (PCI) Baseline
Time Frame: Collection at baseline
The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.
5 times Sit-to-Stand (5 times STS) after 4 weeks
Time Frame: Collection after 4 weeks
The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.
6 minute Timed Walk Test (6m TWT) after 4 weeks
Time Frame: Collection after 4 weeks
The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.
2 Dimensional Video Motion Analysis (2D Video Analysis) Baseline
Time Frame: Collection at baseline
2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.
2 Dimensional Video Motion Analysis (2D Video Analysis) after 4 weeks
Time Frame: Collection after 4 weeks
2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.
Hill Assessment Index (HAI) after 4 weeks
Time Frame: Collection after 4 weeks
The HAI is a functional test that measures quality of walking up and down a sloped ramp.
L-Functional Test (L-Test) after 4 weeks
Time Frame: Collection after 4 weeks
The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.
Physiological Cost Index (PCI) after 4 weeks
Time Frame: Collection after 4 weeks
The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.
Secondary Outcomes
- Activities-Specific Balance Confidence Scale (ABC)(Collection after 4 weeks)
- Orthotic Prosthetic User Survey (OPUS)(Collection after 4 weeks)
- Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS)(Collection after 4 weeks)
- Prosthesis Limb User Survey of Mobility (PLUS-M)(Collection after 4 weeks)
- Socket Comfort Score (SCS)(Collection at baseline and after 4 weeks)