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.: PACTR202310730287500 Date of Approval: 06/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The comparison of task-based mirror therapy versus constraint induced movement therapy on upper limb functioning in sub-acute stroke patients.
Official scientific title The comparison of task-based mirror therapy versus constraint induced movement therapy on upper limb functioning in sub-acute stroke patients.
Brief summary describing the background and objectives of the trial Background of the study: Stroke is the leading cause of disability globally, second leading cause of death worldwide and the leading cause of medical coma in Nigeria. Among the commonly occurring symptoms of stroke, upper limb motor impairment is one of the long-lasting impairments that eventually lead to disability. Task-based mirror and constraint-induced movement therapy are known neuro-rehabilitation techniques with added benefits of affordability acceptability, adaptability and require less technological advancement making them pragmatically useful in low- and middle-income countries like Nigeria. Aim(s): This study aimed to compare the effectiveness of TBMT to CIMT in upper limb function recovery in sub-acute stroke patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Efficacy
Disease(s) or condition(s) being studied Circulatory System,Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 23/06/2023
Actual trial start date 25/06/2023
Anticipated date of last follow up 04/08/2023
Actual Last follow-up date 07/08/2023
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Ethics committee ADM/E 22/A/VOL.VII/148301156
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CIMT and conventional care 1hour treatment session, three times a week six weeks Constraint induced movement therapy requires constraining the unaffected limb while the affected limb carry out specific tasks. 15
Experimental Group TBMT and conventional care 1hour treatment session, three times a week six weeks Task basked mirror therapy requires movement of the unaffected limb in carrying out specific tasks in front of a mirror 15
Control Group Conventional care 1hour treatment session, Three times a week Six weeks No new intervention added to the patient regular care 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who have been diagnosed of stroke Patients in out-patient ubth physiotherapy neuromedicine department Patients whose stroke incidence is less than 6months but more than two weeks Patients between the ages of 24 – 65years Patients with scores above 24 on the mini-mental status examination(MMSE) Patients with history of other neurological,orthopedic conditions stimulate that affects upper limb functioning Patients who have previously undergone MT and CIMT rehabilitation Patients with visual impairments Patients with short attention span Patients with recurrent stroke Adult: 19 Year-44 Year 20 Year(s) 64 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 15/08/2023 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Benin Teaching Hospital P.M.B. 1111, Benin city, Nigeria Benin city 300283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome upper limb gross motor skill At the beginning before intervention is administered and at the end of the six weeks duration after intervention
Primary Outcome fine motor skill. Baseline before treatment and after treatment six weeks later
Primary Outcome upper limb muscle strength. Baseline before treatment and after treatment six weeks later
Secondary Outcome Activities of daily living. Baseline before treatment and after treatment six weeks later
Primary Outcome Hand manipulation skill. Baseline before treatment and after treatment six weeks later
Secondary Outcome stroke severity. Baseline before treatment and after treatment six weeks later
Secondary Outcome Health related quality of life Baseline before treatment and after treatment six weeks later
Primary Outcome Range of motion Baseline before treatment and after treatment six weeks later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin teaching hospital PMB. 1154, Ugbowo, Benin City, Nigeria. Benin city 300213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Joy Mba 27, onipede street, lawanson Lagos 100254 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Joy Mba 27, onipede street, lawanson Lagos city 100254 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joy Mba mbajoy100@gmail.com +2348141683487 27, Onipede street, itire, Lawanson, Lagos state
City Postal code Country Position/Affiliation
Lagos 101283 Nigeria student
Role Name Email Phone Street address
Scientific Enquiries Nelson Ekechukwu subhypothesis@gmail.com +2348032298217 university of benin, ugbowo, benin city
City Postal code Country Position/Affiliation
Benin city 300283 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Aleter igheghede mbajoy100@gmail.com 07032293225 new road, aburime estate, isihor road, uselu, benin city
City Postal code Country Position/Affiliation
Benin city 300283 Nigeria universityof benin teaching hospital medical staff
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participants data shared would include participants’ ages; gender; marital status; religion; dominant limb; and laterality of affectation. The baseline data and post-intervention data of all participants for each tool used will also be shared Documents like the study protocol, the informed consent and data analysis of the participants information will also be made available. The above data will all be available following publication for any purposes Informed Consent Form,Statistical Analysis Plan,Study Protocol no end date Accessibility
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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