Clinical Trial: Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

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 Summary: 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.
Sponsor: VA Office of Research and Development

Current Primary Outcome:

• 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)

Original Primary Outcome: X-Ray Reconstruction of Moving Morphology (XROMM) [ Time Frame: After 4 weeks of home use ]

Current Secondary Outcome:

• Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) [ Time Frame: 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.
• Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome:

• Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) [ Time Frame: after 2 weeks of home use of each socket type ]
  This is a 10 item scale related to prosthetic satisfaction which 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.
• Prosthetic Evaluation Questionnaire (PEQ) [ Time Frame: after 2 weeks of home use of each socket type ]
  The study will utilize 5 pertinent items from the PEQ related to: 1) temperature and texture of socket, 2) sweat inside socket, 3) sweat inside socket, 4) fit of prosthesis, 5) impact of swelling of residual limb on fit of prosthesis.

Dates:
Date Received: February 27, 2012
Date Started: January 2012
Date Completion:
Last Updated: November 17, 2014
Last Verified: November 2014