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

Completed · Not applicable

Conditions studied: Amputation Balance Prosthesis

In brief

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.

Key facts

Study ID

NCT04657614

Run by

Loma Linda University

People needed

7

Starts

2021-03-17

Expected to finish

2021-07-08

Last updated by the study team

2021-07-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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