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.

Study Overview

• Status: Completed
• Conditions: Amputation Balance Prosthesis
• Intervention / Treatment: Other: Neutral Alignment; Other: Anterior Alignment; Other: Posterior Alignment

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Michael Davidson, MSE MPH, Loma Linda University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2021
• Primary Completion (ACTUAL): July 8, 2021
• Study Completion (ACTUAL): July 8, 2021

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 5200455

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No