Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Conditions
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Traumatic Amputation of Arm

Intervention / Treatment
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* Other: Skeletal Stabilization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional 1, Skeletal Stabilization 2<br>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. | Other: Skeletal Stabilization<br>* Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization<br>* Other names: Skeletal Stabilization Socket;|
| Experimental: Skeletal Stabilization 1, Traditional 2<br>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. | Other: Skeletal Stabilization<br>* Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization<br>* Other names: Skeletal Stabilization Socket;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degrees of Shoulder Abduction Within the Prosthetic Socket | 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) | After 4 weeks of home use (2 weeks for each socket style) | 
| Degrees of Shoulder Internal Rotation Within the Prosthetic Socket | 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) | After 4 weeks of home use (2 weeks for each socket style) | 
| Degrees of Shoulder Displacement Within the Prosthetic Socket | 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) | After 4 weeks of home use (2 weeks for each socket style) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) | 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. | After 4 weeks of home use (2 weeks for each socket style) | 
| Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale | 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. | after 2 weeks of home use of each socket type | 
| Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale | 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. | After 4 weeks of home use (2 weeks for each socket style) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation, Prosthesis Design, Biomechanics