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.: PACTR202301605291913 Date of Approval: 23/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EffIcacy of telerehabilitation in facilitating compliance to upper extremity home programs and associated functional regain among chronic post-stroke patients
Official scientific title Effect of Telerehabilitation in Facilitating Upper Extremity Home Programs among Stroke Patients
Brief summary describing the background and objectives of the trial Stroke is a leading cause of disability in adults, requiring regular patient-therapist contacts to achieve greater functional regain of the affected extremities. Events such as the recent Covid-19 pandemic coupled with a low therapist-to-patient ratio has further limited access to rehabilitation services. A proliferation of Telerehabilitation and Telemedicine to ameliorate these healthcare challenges have been palpable in the recent years across the globe. The objective of this study is to gather preliminary evidence on the feasibility and effect of telerehabilitation in Facilitating upper extremity home programs among stroke patients. To determine whether the use of telerehabilitation leads to improved ability to perform activities of daily living amongst stroke survivors when compared with usual care group. To determine whether use of telerehabilitation leads to greater independence in activities of daily living, upper limb function, and quality of life when compared with usual care. we aimed to report levels of user satisfaction associated with telerehabilitation interventions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 20/07/2021
Actual trial start date 15/08/2022
Anticipated date of last follow up 11/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 14
Actual target sample size (number of participants)
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TELEREHABILITATION Physiotherapist-patient contact via Telerehabilitation services will be limited to 3-5 times a week. 4 weeks Regular physiotherapy clinic visits (usual care) and telephone calls (telerehabilitation). The intervention group received physiotherapy concurrently with Telerehabilitation (as part of home program) for the period of 4 weeks. Telephone calls will be used to handle complaints and questions, but not to review and adjust the exercise prescription. Adjustment of exercises prescribed was done during the usual hospital visits. 7
Control Group USUAL CARE Participants in the control group will receive only the usual care, consisting of visits to physiotherapy outpatient clinics as needed and regular home program. twice a week. 4 WEEKS Participants in the control group will receive only the usual care, consisting of visits to physiotherapy outpatient clinics as needed and regular home program.Control group (Usual care only) will performed a task-oriented, individually tailored, intensive 4 weeks rehabilitation program. For each participant, a physiotherapist will prescribe an individualized exercise program with appropriate mode and intensity (number of repetitions) based on characteristics of the participant’s impairments observed at the baseline assessments. During the study, participants’ rehabilitation will progress through an exercise that encompasses essential components of reaching, grasping, holding and manipulation with increasing level of difficulty. The level of difficulty will be chosen to make the tasks challenging but not impossible. 7 Active-Treatment of Control Group
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 or hemiparesis Age between 40 to 65 years on the day of data collection Stroke of ≥ 6 months, Stable cognitive functioning (Montreal Cognitive Assessment (MoCA) ≥ 26 Stable clinical condition. Cognitive impairment such as apraxia neglect and language disturbances interfering with verbal comprehension Disturbed unaffected upper limb function Medical complications Other problems possibly contra-indicating autonomous exercise at home Middle Aged: 45 Year(s)-64 Year(s) 40 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 18/05/2021 MINISTRY OF HEALTH AND HUMAN SCIENCES
Ethics Committee Address
Street address City Postal code Country
NEAR YOBE STATE SPECIALIST HOSPITAL ALONG GUJBA ROAD BYE PASS damaturu 620101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fugl-Meyer upper extremity Motor Assessment (FMA-UE). Wolf Motor Function test Baseline and at 4 weeks
Secondary Outcome WHOQOL-Bref. Barthel Index Activities of Daily Living (ADL). baseline and at 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
yobe state university teaching hospital damaturu damaturu yobe 620101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Hafsat Maina Ali YOBE STATE UNIVERSITY TEACHING HOSPITAL DAMATURU 620101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UMAR BELLO Caledonia University. UNITED KINGDOM G4 OBA United Kingdom Individual
COLLABORATORS
Name Street address City Postal code Country
Abdullahi salisu muhammad yobe state university teaching hospital damaturu 620101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator HAFSAT ALI hafsymaina@gmail.com +2348065003066 i pent 7 estate gwarimpa estension
City Postal code Country Position/Affiliation
abuja 900108 Nigeria physiotherapist
Role Name Email Phone Street address
Public Enquiries ABDULLAHI MUHAMMAD abdullahisalisu73@gmail.com +2348031321849 3 BEDROOM ROAD MAIDUGURI ROAD
City Postal code Country Position/Affiliation
DAMATURU 620101 Nigeria PHYSIOTHERAPIST
Role Name Email Phone Street address
Scientific Enquiries UMAR BELLO UMAR.M.BELLO@CONNECT.POLYU.HK +2348060496060 Glasgow Caledonia University
City Postal code Country Position/Affiliation
GLASGOW G4 OBA United Kingdom 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 descriptive and inferential statistics, 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