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.: PACTR201712002689193 Date of Approval: 13/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of 6 weeks task-oriented circuit training on balance and quality of life of stroke
Official scientific title Effect of 6 weeks task-oriented circuit training on balance and quality of life of stroke survivors
Brief summary describing the background and objectives of the trial The objective of the study is to determine the effect of 6 weeks task-oriented circuit training on balance and quality of life of stroke survivors
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 Physical activity and nutrition
Anticipated trial start date 15/01/2018
Actual trial start date
Anticipated date of last follow up 02/03/2018
Actual Last follow-up date 30/03/2018
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomization using a randomization table created by a computer software This was done by a research assistant who is not aware which group is for the experimental or control Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised This was done by a research assistant who is not aware which group is for the experimental or control Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Task-oriented circuit training 3 times per week 6 weeks balance training with gym ball, double leg standing, tadem walking, standing and walking, walking exercise and squatting exercise 15
Control Group Conventional Physiotherapy 3 times per week 6 weeks Bringing exercise, segmental rotation and walking reduction 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Out patient stroke survivors that have ability to walk 10 meters without with or without walking aid stroke survivors with post stroke duration of 1-6 months Stroke survivors with uncontrolled hypertension Stroke survivors with an form of balance impairment other than stroke stroke survivors with history of fracture or surgical procedure in the lower limb stroke survivors with any musculoskeletal disorder such as osteoarthritis 18 Year(s) 60 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
No 30/10/2017 Ethical and Review Committee of the University of Maiduguri Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Bama Road Maiduguri 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Berg Balance Scale 20mins
Secondary Outcome Stroke Specific Quality of Life Scale 15mins
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
State Specialist Hospital Maiduguri Shehu Laming Way Maiduguri 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Damboa Road Maiduguri 234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self Damboa Road Maiduguri 234 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. Grace Vincent-Onabajo Bama Road Maiduguri 234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wasinda Malgwi sinda4life@gmail.com +234 Damboa Road
City Postal code Country Position/Affiliation
Maiduguri 234 Nigeria
Role Name Email Phone Street address
Public Enquiries Wasinda Malgwi sinda4life@gmail.com +234 Damboa Road
City Postal code Country Position/Affiliation
Maiduguri 234 Nigeria
Role Name Email Phone Street address
Scientific Enquiries Wasinda Malgwi sinda4life@gmail.com +234 Damboa Road
City Postal code Country Position/Affiliation
Maiduguri 234 Nigeria
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