Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202006792038036 Date of Approval: 22/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of a novel foot prosthesis on biomechanical characteristics, functional capacity and lifestyle patterns of unilateral transtibial amputees living in South Africa
Official scientific title 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
Brief summary describing the background and objectives of the trial Currently, most individuals with transtibial (TTA) living in South Africa use a conventional solid-ankle cushioned-heel foot prosthesis. This type of prosthesis is a rudimentary prosthesis: a key disadvantage is the deviation in gait pattern away from “normal gait”. In recent years, advanced energy storage and return (ESAR) prostheses have become more readily available to individuals with TTA, and have been designed specifically to provide a “more normal gait” in the TTA population, through various mechanisms. The present study is the first study to assess the differences in biomechanical characteristics, functional capacity, perceptions of quality of life and physical activity patterns in a novel ESAR foot (Pro-Flex foot, Ossur, Iceland), the current gold standard ESAR foot (Vari-Flex foot, Ossur, Iceland) and the conventional foot in a sample of South African individuals with unilateral TTA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 10/07/2017
Actual trial start date 10/07/2017
Anticipated date of last follow up 04/10/2018
Actual Last follow-up date 04/10/2018
Anticipated target sample size (number of participants) 21
Actual target sample size (number of participants) 20
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table from a statistics book Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Proflex Pro-flex foot prosthesis prescribed to be worn full time 2 weeks Adaptation to the prosthesis over a 2 week period 20
Experimental Group Variflex Vari-flex foot prosthesis prescribed to be worn full time 2 weeks Adaptation to the prosthesis over a 2 week period 20
Control Group SACH SACH foot prosthesis prescribed to be worn full time 2 weeks Adaptation to the prosthesis over a 2 week period 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• 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). • 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). Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 23 Year(s) 77 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/11/2016 Stellenbosch University Health Research Ethics Committee 2
Ethics Committee Address
Street address City Postal code Country
Research Development, 5th Floor, Teaching Building, Tygerberg Campus, Stellenbosch University, Francie van Zij Drive, Parow Cape Town 7600 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Kinetics, kinematics and neuromuscular activation during walking, fast walking, stair walking, sit-to-stand-to-sit and single leg balance Every 2 weeks after acclimatization on each foot
Primary Outcome Functional performance on a 6-minute walk test and obstacle course Every 2 weeks after acclimatization on each foot
Secondary Outcome Prosthesis satisfaction, daily fatigue, quality of life questionnaires Every 2 weeks after acclimatization on each foot
Secondary Outcome Physical activity patterns over 5 days recorded by wrist-worn activity monitor Every 2 weeks after acclimatization on each foot
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institute of Sport and Exercise Medicine Clinical Building, Faculty Medicine and Health Sciences, Francie van Zijl Drive, Tygerberg Cape Town 7500 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Ossur 5 Grjothals 110 Reykjavik Iceland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Ossur South Africa 55 London Circle, Brackenfell South Cape Town 7560 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wayne Derman ewderman@sun.ac.za +27219389801 ISEM, 4th Floor, Clinical Building, FMHS, Tygerberg Campus, Frnacie van Zijl Street, Parow
City Postal code Country Position/Affiliation
Cape Town 7600 South Africa Professor and Director of the Institute of Sport and Exercise Medicine
Role Name Email Phone Street address
Public Enquiries Phoebe Runciman para@sun.ac.za +27218084599 Room 402, Sport Science Building, Coetzenburg Street
City Postal code Country Position/Affiliation
Stellenbosch 7600 South Africa Lecturer. Sport Science Department
Role Name Email Phone Street address
Scientific Enquiries Phoebe Runciman para@sun.ac.za +27218084599 Room 402, Sport Science Building, Coetzenburg Street
City Postal code Country Position/Affiliation
Stellenbosch 7600 South Africa Lecturer. Sport Science Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participants data collected during the trial will be made available upon proposal request. Proposals can be sent to ewderman@iafrica.com. To gain access, requestors will need to sign a data access agreement. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available for 5 years after publication. Individual participant meta-analyses. To achieve aims in the approved data request proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
To be confirmed after first publication No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information