Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Not Applicable

Completed

Conditions: Traumatic Amputation of Arm

Interventions: Other: Skeletal Stabilization

Registration Number: NCT01546675

Lead Sponsor: US Department of Veterans Affairs

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Traditional 1, Skeletal Stabilization 2	Skeletal Stabilization	Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design. The intervention is the socket designed to increase skeletal stabilization.
Skeletal Stabilization 1, Traditional 2	Skeletal Stabilization	Subjects using the socket hypothesized to increase skeletal stabilization and Traditional Socket and in a case cross-over design. The intervention is the socket designed to increase skeletal stabilization.

Primary Outcome Measures

Name	Time	Method
Degrees of Shoulder Abduction Within the Prosthetic Socket	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	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	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 Outcome Measures

Name	Time	Method
Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale	after 2 weeks of home use of each socket type	The 8-item utility subscale includes items related to prosthetic socket utility including: comfort, fit, ease of donning and doffing and feel on the residual limb. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.
Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale	After 4 weeks of home use (2 weeks for each socket style)	The 6-item residual limb health scale includes items about the bothersome of sweating, smell, swelling, ingrown hairs, rashes and blisters. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.
Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)	After 4 weeks of home use (2 weeks for each socket style)	This 10 item scale includes items related to satisfaction with aspects of the prosthesis. It includes questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated on a 5 point scale from very dissatisfied to very satisfied. Scores are summed and the average of the 10 items are calculated. Higher scores indicate greater satisfaction. Scores range from 1-5.

Trial Locations

Locations (2): Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
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New York, New York, United States
Providence VA Medical Center, Providence, RI
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Providence, Rhode Island, United States