Amputation Balance Prosthesis
Conditions
Brief summary
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
Initial Visit: 1. Informed consent 2. HIPAA 3. Foot Inspection 4. Review expectations 5. Take measurements 6. 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\* 1. Five times sit-to-stand test (5XSTS). 2. Activities-Specific Balance Confidence (ABC-16) scale 3. 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) 4. A Polar H10 heart rate monitor will be worn while subjects perform each of the various tests.
Interventions
OTHERNeutral Alignment
Alignment that is a neutral replicate of the participants prescribed prosthesis.
OTHERAnterior Alignment
Alignment that is anterior displaced pylon.
OTHERPosterior Alignment
Alignment that is posteriorly displaced pylon.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
A sock will be placed over the prosthesis in order for the participant to not know which alignment is used.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5 Time Sit to Stand Test | three weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activities-Specific Balance Confidence Questionnaire | three weeks | Measure of balance and confidence in performing various activities. |
| Balance test | three weeks | 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. |
Countries
United States
Outcome results
None listed