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.: PACTR201809766183160 Date of Approval: 12/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Transcranial Direct Current Stimulation and Repetitive Functional Task-Oriented Programme on Physical Functioning and Quality of Life of Stroke Survivors
Official scientific title Efficacy of Transcranial Direct Current Stimulation and Repetitive Functional Task-Oriented Programme on Physical Functioning and Quality of Life of Stroke Survivors
Brief summary describing the background and objectives of the trial Progress in stroke prevention and advances in treatment of acute-phase of stroke have significantly increased the survival rates of stroke individuals, but long-term impairments limit physical functioning and quality of life (QoL). Without stroke rehabilitation, physical functional limitations and decrease QoL can persist or worsen over time, leading to increased dependence and caregivers’ burden. Therefore rehabilitation approach and therapy that increase neuroplasticity stroke will be of immense importance to the body of research, academic and clinical practice. This study is therefore designed to determine the therapeutic efficacy of transcranial direct current stimulation and repetitive functional task-oriented programme on physical functioning and quality of life of stroke survivors.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) tDCS
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 01/08/2017
Actual trial start date 01/05/2018
Anticipated date of last follow up 30/04/2019
Actual Last follow-up date 31/05/2019
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 78
Recruitment status Completed
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Anodal group 1.6 mA tDCS for 20 minute + Repetitive Functional Task Oriented Programme 12 sessions. twice in a week for six weeks The Anodal transcranial direct current stimulation (tDCS) device provided tDCS delivered at 1.6mA using rectangular in shape conductive rubber electrodes that was padded by saline-soaked electrode sponge. The stimulation time was 20 minutes per session. The Repetitive Functional Task Oriented Programme consisted of a structured series of 60-minute sessions. The content will focus on the repetition and relearning of functional task and activities that will be performed with the affected hemispace at a level that is challenging but within each survivor’s potential. The anode electrode was placed on the projection of the hand knob area of the primary motor cortex of the affected hemisphere (the M1 (C3 or C4 according to the EEG 10/20 system) hand area of the ipsilesional hemisphere). The reference electrode was positioned on the skin overlying the contralateral supraorbital region 26
Control Group Control group 60-minute sessions 12 sessions. twice in a week for 6 weeks The RFTOP will consist of a structured series of 60-minute sessions. The content will focus on the repetition and relearning of functional task and activities that will be performed with the affected hemispace at a level that is challenging but within each survivor’s potential. 25 Active-Treatment of Control Group
Experimental Group Cathodal group 1.6 mA tDCS for 20 minute + Repetitive Functional Task Oriented Programme 12 sessions. twice in a week for 6 weeks The cathodal transcranial direct current stimulation (tDCS) device provided tDCS delivered at 1.6mA using rectangular in shape conductive rubber electrodes that was padded by saline-soaked electrode sponge. The stimulation time was 20 minutes per session. The Repetitive Functional Task Oriented Programme consisted of a structured series of 60-minute sessions. The content will focus on the repetition and relearning of functional task and activities that will be performed with the affected hemispace at a level that is challenging but within each survivor’s potential The cathode electrode was placed on the projection of the hand knob area of the primary motor cortex of the unaffected hemisphere (the M1 hand area of the contralesional hemisphere). The reference electrode was positioned on the skin overlying the contralateral supraorbital region. 27
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. First-ever stroke survivors older than eighteen (18) years with diagnosis of stroke confirmed by Computerised Tomography and/or Magnetic Resonance Imaging. ii. Stroke survivors with not less than 3 months of stroke onset. iii. Stroke survivors who are literate (English and/or Yoruba languages). iv. Stroke survivors with more than a score of 4 on Box and Block Test. v. Stroke survivors with less than a grade of 3 on Modified Ashworth Scale vi. Stroke survivors with a score more than 23 points on Mini-Mental State Examination (MMSE) and are able to understand verbal, graphic, pictorial and written instructions. i. Stroke survivors with pre-existing neurological or psychiatric conditions such as dementia, schizophrenia, seizure, epilepsy. ii. Stroke survivors with intracranial metallic implants or pacemaker iii. Stroke survivors with significant impairment in visual acuity caused by cataracts, diabetic retinopathy, glaucoma or hemianopia. iv. Stroke survivors with concomitant medical conditions like anthropathy, osteopathy, myopathy, severe diseases of the lung, heart, liver or kidney. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 120 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 31/07/2017 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room 107, 1st Floor, LUTH Administrative Block, Lagos Lagos 100254 Nigeria
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 29/09/2017 Directorate of Clinical Services and Training and Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi Road, Ikeja Ikeja 112106 Nigeria
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 24/07/2018 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room 107, 1st Floor, LUTH Administrative Block Lagos 100254 Nigeria
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 08/08/2018 Lagos State Government Health Service Commission
Ethics Committee Address
Street address City Postal code Country
Ganiu Smith Street, Lagos Island Lagos 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fugl-Meyer Assessment of Motor Recovery after Stroke Baseline and Post-Intervention
Primary Outcome Stroke-Specific Quality of Life scale. Baseline and Post-Intervention
Primary Outcome 10 Meter Walk Test Baseline and Post-Intervention
Primary Outcome Box and Block Test Baseline and Post-Intervention
Secondary Outcome Mini Mental State Examination Baseline
Primary Outcome Frenchay Activities Index Baseline and Post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Idi-Araba, Lagos Lagos 100254 Nigeria
Lagos University Teaching Hospital Ikeja Ikeja Lagos 112106 Nigeria
General Hospital Marina Odan Lagos 23401 Nigeria
General Hospital Gbagada Gbagada Lagos 23401 Nigeria
General Hospital Isolo Isolo Lagos 23401 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adeagbo Caleb Adewumi Department of Physiotherapy, College of Medicine of the University of Lagos Lagos 100254 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Caleb Adeagbo cadeagbo@unilag.edu.ng +2348029308831 Department of Physiotherapy, College of Medicine of the University of Lagos
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Caleb Adeagbo cadeagbo@unilag.edu.ng +2348029308831 Department of Physiotherapy, College of Medicine of the University of Lagos
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Assistant Lecturer
Role Name Email Phone Street address
Scientific Enquiries Caleb Adeagbo cadeagbo@unilag.edu.ng +2348029308831 Department of Physiotherapy, College of Medicine of the University of Lagos
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Assistant Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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