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

NCT ID: NCT04657614

Last Updated: 2021-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2021-07-08

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.

Conditions

Amputation Balance Prosthesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Neutral Alignment Group

A straight pylon with the ankle at neutral.

Group Type: EXPERIMENTAL

Neutral Alignment

Intervention Type: OTHER

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

Anterior Alignment Group

An anteriorly displaced pylon with ankle dorsiflexion at 5 degrees.

Group Type: EXPERIMENTAL

Anterior Alignment

Intervention Type: OTHER

Alignment that is anterior displaced pylon.

Posterior Alignment Group

A posteriorly displaced pylon with 5 degrees of plantarflexion at the ankle.

Group Type: EXPERIMENTAL

Posterior Alignment

Intervention Type: OTHER

Alignment that is posteriorly displaced pylon.

Interventions

Neutral Alignment

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

Intervention Type: OTHER

Anterior Alignment

Alignment that is anterior displaced pylon.

Intervention Type: OTHER

Posterior Alignment

Alignment that is posteriorly displaced pylon.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Michael Davidson

Assistant Professor Orthotics and Prosthetics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Davidson, MSE MPH

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

Other Identifiers

5200455

Identifier Type: -

Identifier Source: org_study_id