The effect of a novel foot prosthesis on biomechanical characteristics, functional capacity and lifestyle patterns of unilateral transtibial amputees living in South Africa

Not Applicable

• Conditions: Injury, Occupational Diseases, Poisoning; Musculoskeletal Diseases; Orthopaedics

• Registration Number: PACTR202006792038036

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-29
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

•Both male and female participants will be recruited.
•Age between 18 and 80 years old.
•Previous traumatic transtibial amputation.
•Diabetes-related transtibial amputation. Only participants with controlled diabetes will be included in this study.
•Amputation that occurred at least one year prior to testing.
•Unilateral transtibial amputation.
•The participant must pass medical screening and gain clearance to participate in exercise testing by a suitably qualified medical practitioner.
•The participant must be free of significant stump-socket interface pathology (as indicated by the socket fit comfort score (SFCS) scale).

Exclusion Criteria

•Uncontrolled cardiovascular or metabolic disease (hypertension, type I and II diabetes, cardiac arrhythmias, etc.).
•Uncontrolled residual limb disturbances or problems (pressure sores, infection, etc.) as indicated by the SFCS score.
•Any musculoskeletal surgery in the past one year.
•Bilateral transtibial amputation.
•Any musculoskeletal injury on the involved or sound side of the body that would interfere with walking exercise (to be determined by either their own prosthetist, or suitably qualified medical practitioner).

Study & Design

• Study Type: Interventional
• Study Design: Not specified