Traumatic Amputation of Arm
Conditions
Keywords
Amputation, Prosthesis Design, Biomechanics
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.
Interventions
OTHERSkeletal Stabilization
Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization
Sponsors
Lifespan
Brown University
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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 | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Experimental: Skeletal Stabilization 1, Traditional 2 | Total | Active Comparator: Traditional 1, Skeletal Stabilization 2 |
|---|---|---|---|
| Age, Continuous | 29 years | 24.5 years | 20 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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)
Time frame: After 4 weeks of home use (2 weeks for each socket style)
Population: One male and one female with traumatic amputation at the transhumeral level.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Degrees of Shoulder Abduction Within the Prosthetic Socket | Traditional Socket | 42.5 degrees |
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Degrees of Shoulder Abduction Within the Prosthetic Socket | Skeletal Stabilization Socket | 27 degrees |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Degrees of Shoulder Abduction Within the Prosthetic Socket | Skeletal Stabilization Socket | 23.7 degrees |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Degrees of Shoulder Abduction Within the Prosthetic Socket | Traditional Socket | 20.3 degrees |
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)
Time frame: After 4 weeks of home use (2 weeks for each socket style)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Degrees of Shoulder Displacement Within the Prosthetic Socket | Skeletal Stabilization Socket | 4.4 degrees |
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Degrees of Shoulder Displacement Within the Prosthetic Socket | Traditional Socket | 3.1 degrees |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Degrees of Shoulder Displacement Within the Prosthetic Socket | Skeletal Stabilization Socket | 5.3 degrees |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Degrees of Shoulder Displacement Within the Prosthetic Socket | Traditional Socket | 37.0 degrees |
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)
Time frame: After 4 weeks of home use (2 weeks for each socket style)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Degrees of Shoulder Internal Rotation Within the Prosthetic Socket | Skeletal Stabilization | 17.1 degrees |
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Degrees of Shoulder Internal Rotation Within the Prosthetic Socket | Traditional Socket | 14.1 degrees |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Degrees of Shoulder Internal Rotation Within the Prosthetic Socket | Skeletal Stabilization | 5.9 degrees |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Degrees of Shoulder Internal Rotation Within the Prosthetic Socket | Traditional Socket | 21.6 degrees |
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.
Time frame: After 4 weeks of home use (2 weeks for each socket style)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale | Skeletal Stabilization Socket | 4.7 units on a scale |
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale | Traditional Socket | 6.2 units on a scale |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale | Skeletal Stabilization Socket | 5.5 units on a scale |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale | Traditional Socket | 4.7 units on a scale |
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.
Time frame: after 2 weeks of home use of each socket type
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale | Skeletal Stabilization Socket | 3.4 units on a scale |
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale | Traditional Socket | 5.4 units on a scale |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale | Skeletal Stabilization Socket | 4.3 units on a scale |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale | Traditional Socket | 6.6 units on a scale |
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.
Time frame: After 4 weeks of home use (2 weeks for each socket style)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) | Traditional Socket | 3.4 units on a scale |
| Active Comparator: Traditional 1, Skeletal Stabilization 2 | Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) | Skeletal Stabilization Socket | 2.7 units on a scale |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) | Skeletal Stabilization Socket | 3.2 units on a scale |
| Experimental: Skeletal Stabilization 1, Traditional 2 | Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) | Traditional Socket | 5 units on a scale |