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

Amputation Balance Prosthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657614
• Other study ID #: 5200455
• Status: Completed
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: July 8, 2021

Study information

• Verified date: July 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation Balance Prosthesis

Intervention

Other:
• Neutral Alignment
Alignment that is a neutral replicate of the participants prescribed prosthesis.
• Anterior Alignment
Alignment that is anterior displaced pylon.
• Posterior Alignment
Alignment that is posteriorly displaced pylon.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Activities-Specific Balance Confidence Questionnaire	Measure of balance and confidence in performing various activities.	three weeks
Secondary	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