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Clinical Trials/NCT04657614
NCT04657614
Completed
N/A

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

Loma Linda University1 site in 1 country7 target enrollmentMarch 17, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Amputation Balance Prosthesis
Sponsor
Loma Linda University
Enrollment
7
Locations
1
Primary Endpoint
5 Time Sit to Stand Test
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 17, 2021
End Date
July 8, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Davidson

Assistant Professor Orthotics and Prosthetics

Loma Linda University

Eligibility Criteria

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

Outcomes

Primary Outcomes

5 Time Sit to Stand Test

Time Frame: 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 Outcomes

  • Balance test(three weeks)
  • Activities-Specific Balance Confidence Questionnaire(three weeks)

Study Sites (1)

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