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The purpose of this graduate student research study is to determine the effect of various linear and angular prosthetic alignments on K1-K3 unilateral or bilateral TT amputees, as well as test for proficiency, comfort, balance, heart rate and fit during sit to stands.
Initial Visit:
Second Visit: Fitting and adjusting accordingly.
Third, Fourth and Fifth Visit: Testing (5-10-minute rest period in between each test) *Testing will be video recorded for re-assessment of subjects*
Five times sit-to-stand test (5XSTS).
Activities-Specific Balance Confidence (ABC-16) scale
Balance Master:
Weight Bearing Squat (WBS) Unilateral Stance (US) Sensory Organization Test (SOT) modified Clinical Test of Sensory Interaction on Balance (mCTSIB) Limits of Stability (LOS)
A Polar H10 heart rate monitor will be worn while subjects perform each of the various tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neutral Alignment Group | Experimental | A straight pylon with the ankle at neutral. |
|
| Anterior Alignment Group | Experimental | An anteriorly displaced pylon with ankle dorsiflexion at 5 degrees. |
|
| Posterior Alignment Group | Experimental | A posteriorly displaced pylon with 5 degrees of plantarflexion at the ankle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neutral Alignment | Other | Alignment that is a neutral replicate of the participants prescribed prosthesis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5 Time Sit to Stand Test | The sit to stand test will be administered five times uninterrupted. The participants will sit in a chair and stand up preferably unassisted by researchers. They will be timed. | three weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Activities-Specific Balance Confidence Questionnaire | Measure of balance and confidence in performing various activities. | three weeks |
| Balance test | Smart Balance Master system will be used to measure balance and prosthetic alignment during balance test such as limits of stability and weight bearing squat. |
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Inclusion Criteria:
Male and Female below knee amputees (bi-lateral or unilateral)
18-70 years of age
K1-K3 (K-levels/activity levels)
Those who wear a prosthesis daily for the purpose of walking
Able to get in and out of a chair
Prosthetic foot that has the same functional components as the subject's current one
Exclusion Criteria:
Amputation at birth
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| Name | Affiliation | Role |
|---|---|---|
| Michael Davidson, MSE MPH | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States |
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A sock will be placed over the prosthesis in order for the participant to not know which alignment is used.
| Anterior Alignment | Other | Alignment that is anterior displaced pylon. |
|
| Posterior Alignment | Other | Alignment that is posteriorly displaced pylon. |
|
| three weeks |