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

The effect of a novel energy storage and return foot prosthesis (Pro-flex foot) on biomechanics, function and lifestyle patterns, compared to the gold standard energy storage and return foot prosthesis (Vari-flex foot) and a conventional solid ankle cushioned foot (SACH) prosthesis in South African transtibial amputees

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202006792038036
Enrollment
21
Registered
2020-06-22
Start date
2017-07-10
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury, Occupational Diseases, Poisoning Musculoskeletal Diseases Orthopaedics

Interventions

Proflex
Variflex
SACH

Sponsors

Ossur South Africa
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Kinetics, kinematics and neuromuscular activation during walking, fast walking, stair walking, sit-to-stand-to-sit and single leg balance;Functional performance on a 6-minute walk test and obstacle course

Secondary

MeasureTime frame
Prosthesis satisfaction, daily fatigue, quality of life questionnaires;Physical activity patterns over 5 days recorded by wrist-worn activity monitor

Countries

South Africa

Contacts

Public ContactPhoebe Runciman

Lecturer. Sport Science Department

para@sun.ac.za+27218084599

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026