The Effect of Alternative Prosthetic Alignments on Sit-to-Stand Proficiency in Transtibial Amputees

Study Overview
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Brief Summary
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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.

Detailed Description
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Initial Visit: Informed consent HIPAA Foot Inspection Review expectations Take measurements Casting Second Visit: Fitting and adjusting accordingly. One person will conduct all the measurements, casting, check sockets, etc. to evade inconsistencies in data collection. Begin conducting practice runs on Balance Master at LLU-East Campus. 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.

Official Title
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The Effect of Alternative Prosthetic Alignments on Sit-to-Stand Proficiency in Transtibial Amputees

Conditions
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Amputation Balance Prosthesis

Intervention / Treatment
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* Other: Neutral Alignment
* Other: Anterior Alignment
* Other: Posterior Alignment


Participation Criteria
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Eligibility Criteria
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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) K1=patient has the ability or potential to use a prosthesis for transfers or walking on level surfaces at a fixed speed (typical limited or unlimited household ambulator). K2=patient has the ability or potential for walking with the ability to traverse most low-level environmental barriers such as curbs, stairs, or uneven surfaces (typical community ambulator). K3=patient has the ability or potential for walking with variable speed. Has the ability to traverse most environmental barriers and may have vocational, exercise, or recreational activities that demand prosthetic use beyond simple locomotion. 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 Foot amputation at ankle Uncontrolled edema in leg compartments Compromised skin of the residual limb Patients that are 3 months or less post-amputation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neutral Alignment Group<br>A straight pylon with the ankle at neutral. | Other: Neutral Alignment<br>* Alignment that is a neutral replicate of the participants prescribed prosthesis.<br>|
| Experimental: Anterior Alignment Group<br>An anteriorly displaced pylon with ankle dorsiflexion at 5 degrees. | Other: Anterior Alignment<br>* Alignment that is anterior displaced pylon.<br>|
| Experimental: Posterior Alignment Group<br>A posteriorly displaced pylon with 5 degrees of plantarflexion at the ankle. | Other: Posterior Alignment<br>* Alignment that is posteriorly displaced pylon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | three weeks |