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Completed

NCT Number: NCT04657614

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neutral Alignment

Other

Alignment that is a neutral replicate of the participants prescribed prosthesis.

Anterior Alignment

Other

Alignment that is anterior displaced pylon.

Posterior Alignment

Other

Alignment that is posteriorly displaced pylon.

Primary outcomes

  1. 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

  1. Activities-Specific Balance Confidence Questionnaire

    Time frame: three weeks

    Measure of balance and confidence in performing various activities.

  2. Balance test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2020
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.