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| Name | Class |
|---|---|
| Lifespan | OTHER |
| Brown University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional 1, Skeletal Stabilization 2 | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skeletal Stabilization | Other | Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization |
|
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda J Resnik, PhD MS | Providence VA Medical Center, Providence, RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25425411 | Derived | Resnik L, Patel T, Cooney SG, Crisco JJ, Fantini C. Comparison of transhumeral socket designs utilizing patient assessment and in vivo skeletal and socket motion tracking: a case study. Disabil Rehabil Assist Technol. 2016;11(5):423-32. doi: 10.3109/17483107.2014.981876. Epub 2014 Nov 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design. |
| FG001 | Experimental: Skeletal Stabilization 1, Traditional 2 | Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Cross-over design. Each subject participated under each condition. Total of 2 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design. |
| BG001 | Experimental: Skeletal Stabilization 1, Traditional 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | One male and one female with traumatic amputation at the transhumeral level. | Posted | Number | degrees | After 4 weeks of home use (2 weeks for each socket style) |
|
Adverse Event Data were collected during each participants study duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cases | Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design. |
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These results cannot be generalized outside of this small sample and may have been different if the intervention socket had been optimized. Additional research is needed to expand our understanding of the impact of prosthetic socket designs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Resnik, PT, PhD | Department of Veterans Affairs | 401-273-7100 | 2368 | linda.resnik@va.gov |
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| 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) |
| Providence VA Medical Center, Providence, RI |
| Providence |
| Rhode Island |
| 02908 |
| United States |
Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design. |
|
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| Secondary | 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. | Posted | Number | units on a scale | After 4 weeks of home use (2 weeks for each socket style) |
|
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| Secondary | 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. | Posted | Number | units on a scale | after 2 weeks of home use of each socket type |
|
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|
| Primary | 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) | Posted | Number | degrees | After 4 weeks of home use (2 weeks for each socket style) |
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| Primary | 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) | Posted | Number | degrees | After 4 weeks of home use (2 weeks for each socket style) |
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| Secondary | 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. | Posted | Number | units on a scale | After 4 weeks of home use (2 weeks for each socket style) |
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| 0 |
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| 2 |
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