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The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.
The purpose of the project is to determine the effects of using different prosthetic socket designs with the same suspension and components on the biomechanical asymmetry, residual limb movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10 females per group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veterans with a transtibial amputation | 20 Veterans with a transtibial amputation, 10 females and 10 males |
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| Veterans with a transfemoral amputation | 20 Veterans with a transfemoral amputation, 10 females and 10 males |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional prosthetic socket | Device | Participants will use their own conventional rigid socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomechanical Asymmetry | The assessments of ground reaction forces, and joint motion, torque, power, and work will be aggregated into a measure of asymmetry that compares the percentage difference between the affected and unaffected legs of each participant. The investigators will compare asymmetry between groups and sockets. | through study completion, an average of 4 years |
| Prosthetic Evaluation Questionnaire | The prosthetic evaluation questionnaire assesses comfort and satisfaction. This questionnaire asks participants to rate their comfort and satisfaction based on a 10-point scale and contains 54 questions organized into 9 domain scales, where each scale can be used to independently measure a domain. The investigators will compare overall and domain-specific scores between groups and sockets. | through study completion, an average of 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Socket pistoning | Movement of the residual limb within the socket. The investigators will compared socket pistoning between groups and sockets. | through study completion, an average of 4 years |
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Inclusion Criteria:
The investigators will enroll up to 40 Veterans
All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation
Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator
Exclusion Criteria:
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20 Veterans with unilateral transtibial amputation and 20 Veterans with unilateral transfemoral amputation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alena Grabowski, PhD BA | Contact | (720) 435-4270 | Alena.Grabowski@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Alena Grabowski, PhD BA | Rocky Mountain Regional VA Medical Center, Aurora, CO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Recruiting | Aurora | Colorado | 80045-7211 | United States |
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| Adjustable Quatro socket | Device | Participants will use an adjustable Quatro socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire. |
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