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.: PACTR202208571972367 Date of Approval: 05/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Brunstrom Movement Therapy Telerehabilitation Programme with or without Transcranial Direct Current Stimulation (tDCS) for Improving Pain, Motor and Cognitive Function in Older Adults Patients with Mild Cognitively-Impaired-Stroke.
Official scientific title Telerehabilitation-Based Exercises with or without Transcranial Direct Current Stimulation (tDCS) for Improving Pain, Motor and Cognitive Function in Older Adults Patients with Cognitively-Impaired-Stroke: A Randomized Controlled Trial Study.
Brief summary describing the background and objectives of the trial This study will provide telerehabilitation-based exercises that match Brunnstrom recovery stages and test their efficacy with or without tDCS in managing pain, motor function, and cognitive function in older adults with cognitively impaired stroke. Specifically, the objectives of this study are: 1. To conduct a survey of older adult patients with stroke for pain, motor and cognitive impairment prevalence and associated comorbidities among older adult patients with stroke in UNIOSUN Teaching Hospital, Osogbo, Nigeria. 2. To perform a scoping review on current evidence on Brunnstrom Movement Therapy telerehabilitation-based exercises with or without tDCS for stroke rehabilitation in older adults. 3. To create telerehabilitation Brunnstrom Movement Therapy for cognitively impaired older adults with stroke in BRS 3. In stage 3 of the BRS, the spasticity is at its peak. The implication is that the affected individual will be able to initiate voluntary movement but will not be able to control the movement due to the spasticity. This stage is usually described as the semi-voluntary control of movement. 4. The pilot-feasibility study of telerehabilitation Brunnstrom Movement Therapy for BRS 3 among older adults with mild cognitively impaired stroke will be evaluated at UNIOSUN Teaching Hospital, Osogbo, Nigeria. 5. To investigate the effects of telerehabilitation Brunnstrom Movement Therapy for BRS 3 with tDCS on pain, motor function and cognitive function in older adults with cognitively impaired stroke at UNIOSUN Teaching Hospital, Osogbo, Nigeria. 6. To investigate the effects of telerehabilitation Brunnstrom Movement Therapy for BRS 3 without tDCS on pain, motor function and cognitive function in older adults with cognitively impaired at UNIOSUN Teaching Hospital, Osogbo, Nigeria. 7. To compare the effects of telerehabilitation Brunnstrom Movement Therapy exercises with and without tDCS on pain, motor function and cognitive function in older adults with cognitively
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 03/10/2022
Actual trial start date 03/10/2022
Anticipated date of last follow up 28/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 87
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
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Telerehabilitation and transcranial direct current stimulation tDCS The repetitions of the exercise will be encouraged for 10 repetitions and this exercise will be performed at the sub-maximal training zone of the patient, which will be 55 to 60% of maximal heart rate. This target heart rate zone derivation through Karvonen formula. The frequency of the exercise intervention will last three times per week (45 minutes per session) for eight weeks. For the tDCS, the intensity will be 2mA three times per week (45 minutes per session) for 8 weeks (45 minutes) 8weeks This group will receive Brunnstrom therapy telerehabilitation-based exercises plus tDCS. The Brunnstrom telerehabilitation-based exercises will be delivered in a hospital setting via a video clip on a computer. Similarly, at this time of intervention. The patient will be set for tDCS stimulation. 29
Experimental Group Telerehabilitation The frequency of the exercise intervention will last for three times per week (45 minutes per session). The total treatment session that each participant will undergo will be 25 sessions within the 8 weeks. 8 weeks Brunnstrom Movement therapy via telerehabilitation medium (video clip) 29
Control Group conventional physiotherapy intervention This conventional physiotherapy will last for an hour a session three times per week (45 minutes per session) for 8 weeks. For 8 weeks The conventional physiotherapy intervention will be the Brunnstrom Movement therapy de-signed for telerehabilitation, but this is therapist delivered, not telerehabilitation based. 29 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion and exclusion criteria are based on a recommendation from literature and the definition of subacute stroke by Aguital and associates (2016) as a period of 3 to 6 months post-stroke incidence (Aguiar et al., 2016). This definition will define subacute stroke in this current proposed study. The patients who meet the following criteria will be included in the study: 1. Older adult patients of 55 years and above with mild cognitively impaired stroke (MMSE of 18 to 24). 2. Older adults with mild cognitively impaired stroke with BRS 3. 3. Older adults with stroke having the first episode of unilateral stroke. 4. Participants to be included will be medically stable in vital signs to participate in a telerehabilitation stroke rehabilitation regime. 1. Patients with conditions that may limit their participation will be excluded, such as having uncontrolled high blood pressure, angina, severe visual or hearing limitations, history of epilepsy, acute eczema, migraine schizophrenia and mental disorders. 2. Patients with more than mild cognitive impairment on the MMSE scale will also be excluded from this study as this may affect their participation in telerehabilitation intervention. 3. Patients who refuse the tDCS or telerehabilitation exercises intervention or already having similar tDCS and telerehabilitation exercises intervention will be excluded from the study. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 55 Year(s) 80 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 25/07/2022 Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UKZN Research Ethics Office Westville Campus, Govan Mbeki Building Durban X54001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, Motor and cognition Baseline, 4 week and 8th week
Secondary Outcome Balance/TUG Baseline, 4 week and 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Uniosun Teaching Hospital Osogbo Osogbo Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Tolulope ADENIJI Physiotherapy Department, Redeemers University Ede Ede Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tolulope ADENIJI Redeemers University Ede Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Thayanathee Nadasan Discipline of Physiotherapy,University of Kwazulu-Natal Durban South Africa
Dr Dapo Olagbegi Discipline of Physiotherapy,University of Kwazulu-Natal Durban South Africa
Dr Olumide Dada Physiotherapy Department, University of Ibadan Ibadan Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tolulope ADENIJI tolulopeadeniji86@gmail.com +2347037978961 Physiotherapy Department, Redeemers University Ede
City Postal code Country Position/Affiliation
Ede Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Tolulope ADENIJI tolulopeadeniji86@gmail.com +2347037978961 Physiotherapy Department, Redeemers University Ede
City Postal code Country Position/Affiliation
Ede Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Tolulope ADENIJI tolulopeadeniji86@gmail.com +2347037978961 Physiotherapy Department, Redeemers University Ede
City Postal code Country Position/Affiliation
Ede Nigeria Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This study will make individual data to be available. The data will be shared after publication and de-identification of the participants. The study protocol will be available to anyone who wishes to access the data. The data will be analyzed for scientific and societal good purposes and the data will be made available on request for a period of five years after the study completion. Informed Consent Form,Statistical Analysis Plan,Study Protocol 11 months Any scientist and clinicians may request the data for scientific and clinical purpose
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