NCT04657614

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Amputation Balance Prosthesis

Interventions

Type	Name	Description
OTHER	Neutral Alignment	Alignment that is a neutral replicate of the participants prescribed prosthesis.
OTHER	Anterior Alignment	Alignment that is anterior displaced pylon.
OTHER	Posterior Alignment	Alignment that is posteriorly displaced pylon.

Timeline

• Start date: 2021-03-17
• Primary completion: 2021-07-08
• Completion: 2021-07-08
• First posted: 2020-12-08
• Last updated: 2021-07-12

Locations

1 site across 1 country: United States