Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

• Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) [ Time Frame: after 2 weeks of home use of each socket type ] [ Designated as safety issue: No ]
  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< ] [ Designated as safety issue: No ]
  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.

• Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) [ Time Frame: after 2 weeks of home use of each socket type ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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.

The purpose of this pilot study is 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 will include assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using a novel high-speed, high-resolution, bi-plane video radiography system.

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 is 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.

Male and female transhumeral amputees who are 18 years or older and who are current prosthetic users will be enrolled in this study.

• Group 1
  Subjects will be fit with the Traditional Socket first, and then will be fit with socket design hypothesized to provide greater skeletal stabilization.
  Intervention: Other: Socket
• Group 2
  Subjects will be fit with socket hypothesized to increase skeletal stabilization socket first, and then will be fit with the Traditional Socket.
  Intervention: Other: Socket

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

• Lifespan
• Brown University