Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Traumatic Amputation of Arm
- Sponsor
- US Department of Veterans Affairs
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Degrees of Shoulder Abduction Within the Prosthetic Socket
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization. The investigators comparisons included assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel high-speed, high-resolution, bi-plane video radiography system.
Detailed Description
In the past decade, advances in upper limb socket design and technology have been proposed to increase comfort and decrease perceived weight of the prosthesis. There have been no scientific studies to date that have evaluated the benefits of these designs, and thus no evidence to support use of one type of prosthetic socket design over another. Thus, the overall purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.
Exclusion Criteria
- •Subjects with frozen shoulder of the residual side, and/or severely limited active range of motion of the shoulder joint of the residual limb
- •Inability to tolerate wearing of a prosthetic socket
- •Mental impairment that renders a subject unable to comply with the study
- •Skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevent prior prosthetic wear
- •Any electrically controlled medical device including pacemaker, implanted defibrillator or drug pumps
- •Neuropathy, uncontrolled diabetes, receiving dialysis
- •Any other significant comorbidity which would interfere with the study
- •Severe circulatory problems including peripheral vascular disease and pitting edema will be excluded
- •Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
- •Women who are pregnant or who plan to become pregnant in the near future
Outcomes
Primary Outcomes
Degrees of Shoulder Abduction Within the Prosthetic Socket
Time Frame: After 4 weeks of home use (2 weeks for each socket style)
Shoulder abduction was performed to the subject's maximum elevation. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)
Degrees of Shoulder Internal Rotation Within the Prosthetic Socket
Time Frame: After 4 weeks of home use (2 weeks for each socket style)
Isometric internal rotation was performed with the prosthetic elbow flexed to 90 degrees and shoulder in neutral position. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)
Degrees of Shoulder Displacement Within the Prosthetic Socket
Time Frame: After 4 weeks of home use (2 weeks for each socket style)
A shoulder shrug task was achieved by pulling up on a strap attached to the load cell, which was mounted on the vertical face of the concrete pedestal. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)
Secondary Outcomes
- Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale(after 2 weeks of home use of each socket type)
- Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale(After 4 weeks of home use (2 weeks for each socket style))
- Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)(After 4 weeks of home use (2 weeks for each socket style))