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.: PACTR201803003148269 Date of Approval: 26/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of transcranial direct current stimulation combined with constraint-induced movement therapy on cortical reorganization and functional outcome
Official scientific title Effect of transcranial direct current stimulation combined with constraint-induced movement therapy on cortical reorganization and functional outcome in stroke patients
Brief summary describing the background and objectives of the trial Objective: -To investigate the effect of bihemispheric tDCS on cortical reorganization and functional recovery of the affected upper extremity in chronic stroke patients. -Assessement of the correlation between changes of ipsilesional cortical excitability as a measure of reorganization and functional improvements post intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/07/2015
Actual trial start date 01/10/2015
Anticipated date of last follow up 29/06/2017
Actual Last follow-up date 29/06/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Stopped early/ terminated
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group constraint induced movement therapy and active bilateral transcranial direct current stimulation 10 consecutive days 20 minutes for bilateral transcranial direct current stimulation and 6 hours per day for constraint induced movement therapy Direct current was transferred through pair of saline-soaked surface sponge electrodes. Simultaneous bilateral real stimulation consisted of 20 minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor area. 20 Placebo
Control Group constraint induced movement therapy and sham bihemispheric transcranial direct current stimulation 10 consecutive days 6 hour training for constraint induced movement therapy and 30 seconds forsham bihemispheric transcranial direct current stimulation Participants had to wear a hand mitt on the nonparetic hand which hindered hand and finger activity. The mitt should be worn for at least 90% of waking hours. During the treatment period, all patients received up to 6 hours training per day of the affected arm. Training tasks were designed according to a behavioral ¿shaping¿ technique 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-ischemic stroke in the territory of the middle cerebral artery at least 6 months prior to enrollment -age ranged from 45 to 60 years old -no previous or subsequent strokes -at least 10 degrees active wrist dorsiflexion and extension of the metacarpophalangeal and interphalangeal joints of the thumb and at least 2 additional digits 10 degrees at enrollment spasticity of grade 3 or more other neurologic or orthopedic disorders that could influence upper extremity function history of neurosurgery or epilepsy metallic implants within the brain cardiac pacemaker 45 Year(s) 60 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 05/07/2015 faculty of physical therapy, Cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Al-Zayat street, between the Sarayat, Dokki cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome functional abilities of affected upper extremity at the end of the intervention
Primary Outcome ipsilesional and contralesional cortical excitability using motor evoked potentials at the end of the intervention
Secondary Outcome correlation between functional improvement and changes in cortical excitability at the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of faculty of physical therapy 7 Ahmed Al-Zayat street, between the Sarayat.Dokki. cairo 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo university Cairo university street, in front of Orman park cairo 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university Cairo university street, in front of Orman park cairo 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abd Aleem Ateya 7 Ahmed Al-Zayat street, between the Sarayat, Dokki cairo 12613 Egypt
Abd Aleem Ateya 7 Ahmed Al-Zayat street, between the Sarayat, Dokki cairo 12613 Egypt
Waleed Talat 7 Ahmed Al-Zayat street, between the Sarayat, Dokki cairo 12613 Egypt
Amani Nawito 27 Nafezet sheem El shafaey st., KASR ALAINY cairo 11562 Egypt
Noura Elkafrawy 7 Ahmed Al-Zayat street, between the Sarayat, Dokki cairo 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator noura elkafrawy nouraelkafrawy@icloud.com 01066366879 7 Ahmed Al-Zayat street, between the sarayat ,Dokki
City Postal code Country Position/Affiliation
cairo 12613 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries Abd aleem Ateya aaatteya@gmail.com 01007098435 7 Ahmed Al-Zayat street, between the sarayat ,Dokki
City Postal code Country Position/Affiliation
cairo 12613 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries waleed talat waleed_talat73@yahoo.com 01005311168 7 Ahmed Al-Zayat street, between the sarayat ,Dokki
City Postal code Country Position/Affiliation
cairo 12613 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries amani nawito amani.nawito@kasralainy.edu.eg 01006077405 27 Nafezet sheem El shafaey st., KASR ALAINY
City Postal code Country Position/Affiliation
cairo 11562 Egypt professor
REPORTING
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