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.: PACTR202403746569623 Date of Approval: 28/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Development and testing of Video-Based Telerehabilitation among stroke survivors in Abuja Nigeria.
Official scientific title Development and testing of Video-Based Telerehabilitation among stroke survivors in Abuja Nigeria.
Brief summary describing the background and objectives of the trial BACKGROUND: Rehabilitation therapy after stroke often falls short in providing optimal benefits to patients due to challenges related to restricted access, financial burden, and lack of adherence. A video-based intervention may help overcome the aforementioned barriers and promote adherence OBJECTIVES:To develop and test the feasibility of a video-based telerehabilitation for facilitating upper extremity home programs among stroke survivors
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Stroke cerebral vascular accident
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 09/05/2023
Actual trial start date 09/05/2023
Anticipated date of last follow up 08/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 29
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
FMCABJ HREC 2023 085 Health Research Ethics Committee Federal Medical Centre Jabi
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
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group participants Participants were asked to complete their home exercise programs three times a week for a period of four weeks. four weeks A five-minute video was produced which comprised of four to five exercises, such as shoulder flexion, elbow flexion and extension, forearm supination and pronation, hand slide movement and constrain induced movement therapy. The five minute video chosen for the stroke patient with upper extremity impairment were distributed to the stroke survivors. Patients were asked to watch the video. The video clip was repeated for few minutes depending on the understanding of the patients in which the patient performed the displayed movement with the affected hand. Participants were asked to complete their home exercise programs three times a week for a period of four weeks with no follow up nor access to physiotherapy clinic. After this time, follow-up outcome measures were collected by an assessor. 29
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Episode of a cerebrovascular accident leading to one-sided hemiplegia Modified ranking scale < 2. Adult stroke survivor. Stable cognitive functioning (Montreal Cognitive Assessment, MoCA ≥ 26). Have an available person during the TR session. A phone with internet access. Basic Functional literacy such as practical skill needed to read, write and do math for real life purpose and performing simple tasks to understand short test in stroke survivor with upper extremity impairment A major, active, coexistent neurological or psychiatric disease (including dementia). History of serious chronic obstructive pulmonary disease or oxygen dependence. Having previous upper limb injury or condition that limits upper limb range of motion. Significant visual impairment. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 65 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 09/05/2023 HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
JABI AIRPORT ROAD abuja 7011 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Wolf Motor Function Test. The wolf motor function test was measured at Baseline and after four weeks during the completion of the study
Secondary Outcome Client satisfaction questionnaire (CSQ 8) The client satisfaction questionnaire CSQ 8 was Measured at the completion of the study which is after four weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Jabi Abuja Nigeria Jabi Airport Road FCT Abuja 7011 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded jabi abuja 7011 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor HAFSAT MAINA ALI JABI ABUJA 7011 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
DR Surajo Kamilu Sulaiman Bayero University Kano kano Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator HAFSAT MAINA hafsymaina@gmail.com +2348065003066 jabi
City Postal code Country Position/Affiliation
abuja 7011 Nigeria physiotherapist
Role Name Email Phone Street address
Public Enquiries STEPHEN OGBUNAMMIRI stephenchinonso23@gmail.com +2347030774922 jabi
City Postal code Country Position/Affiliation
ABUJA 7011 Nigeria INTERN PHYSIOTHERAPIST
Role Name Email Phone Street address
Scientific Enquiries KHADIJA ALI khadijat.maina@gmail.com +2348061169001 JABI
City Postal code Country Position/Affiliation
ABUJA 7011 Nigeria PHYSIOTHERAPIST
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available (including data dictionaries). All of the individual participant data collected during the trial, after de-identification will be shared. The document that will be made available includes; Study protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report. Data will be available Immediately following publication, currently no end date. Data will be shared with anyone who wishes to access the data. The type of analyses is a Pre test post test feasibility study, to achieve aims in the approved proposal. The mechanism in which the date will be made available is not applicable Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 Years Open
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