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.: PACTR201802003054396 Date of Approval: 05/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of task training on people affected with stroke in South Africa
Official scientific title The effect of task training on people affected with stroke in South Afrcia
Brief summary describing the background and objectives of the trial The available resources for stroke care and rehabilitation are lacking in developing countries including Africa, particularly in rural areas. It has also been noted that 80% of the population live in areas where factors such as limited resources and cultural practices limit access to stroke services (Poungvarin 1998). Currently patients with stroke are discharged from hospitals in the public healthcare sector within six to 14 days of having a stroke, because of the pressure for beds (Mudzi, 2009; Reid et al., 2005; Hale, 2000). As a result patients are not benefitting from rehabilitation services and this leads to suboptimal recovery post stroke and to a large number of persons living with disabilities in under resourced communities. Because the patients with stroke are discharged so acutely after their stroke, carers become a necessity to cope with the burden of care. These conditions result in increased stroke survivor dependence in South Africa compared to the USA or New Zealand. With this in mind, the aim of this study was to determine if an out -patient based task oriented group training programme would promote improved walking competency more than the current progressive resistance strength group training programmes that are common practice in persons who have had an acute stroke in the public healthcare system in South Africa. The specific objectives of this study were to establish the effect of a low intensity, namely once a week (for six weeks), out- patient based task programme on: walking competency, walking endurance, gait speed and health status in terms of physical functioning in persons with sub-acute stroke.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/01/2009
Actual trial start date 05/01/2009
Anticipated date of last follow up 30/12/2011
Actual Last follow-up date 30/12/2011
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 144
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
Parallel: different groups receive different interventions at same time during study Randomised Computer generated random numbers A research assistant not involved in the trial did the concealed allocation of potential participants to the groups Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Task Six one hour sessions over a 12 week period One hour per session Exercises in standing and walking 51 Active-Treatment of Control Group
Experimental Group Strength Six one hour sessions over a 12 week period One hour per session Exercises in lying and sitting 45 Active-Treatment of Control Group
Control Group Control One educational and exercise session only One hour One educational and exercise session 48 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnosed with stroke-haemorrhagic or ischaemic Aged 20-79 Less than six months post stroke Medically stable Could walk 10 metres in less than 1.1m/s without assistance Could follow instructions Any medical,neurological or orthopaedic condition that interfered with walking 20 Year(s) 79 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 04/05/2007 Human Research Ethics Committee of the University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
7 York Road Parktown 2193 South Africa
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 04/05/2007 Human Research Ethics Committee of the University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
7 York Road Parktown 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Six minute walk test Baseline After 12 week intervention 12 weeks after conclusion of intervention
Secondary Outcome Ten metre gait speed test Baseline After 12 weeks intervention 12 weeks after conclusion of intervention
Secondary Outcome Berg Balance Scale Baseline After 12 week intervention 12 weeks after conclusion of intervention
Secondary Outcome Timed Up and Go Baseline After 12 week intervention 12 weeks after conclusion of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Helen Joseph Hospital 1 Perth Road Johannesburg 2092 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Council Francie van Zyl Drive Parowvallei 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof A Stewart 7 York Road Parktown 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof C Richards Laval University Quebec GIM2S8 Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Megan Knox megan@physicalrehab.co.za +27117173702 7 York Road
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Clinical Educator
Role Name Email Phone Street address
Public Enquiries Aimee Stewart aimee.stewart@wits.ac.za +27117173702 7 York Road
City Postal code Country Position/Affiliation
Parktown 2193 South Africa Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Aimee Stewart aimee.stewart@wits.ac.za +27117173702 Department of Physiotherapy Faculty Health Sciences 7 York Rd Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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