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.: PACTR202401884919252 Date of Approval: 25/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of cognitive behavioral training paradigm on cortical reorganization in patients with stroke
Official scientific title Impact of cognitive behavioral training paradigm on cortical reorganization in patients with stroke
Brief summary describing the background and objectives of the trial Stroke is the single most common cause of adult disability and the third most common cause of death disorders with common cognitive impairment including less attention and memory loss. Objective: To determine the effect of cognitive behavioral training paradigm on cognitive impairment in stroke patients.
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 01/10/2023
Actual trial start date 01/10/2023
Anticipated date of last follow up 24/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cognitive behavioral training paradigm in addition to Cycling exercises For 18 sessions every other day one and half month puzzle and problem solving, mathematics or memory training. 15
Control Group Cycling exercises 18 sessions , day after day One month and half Moderate intensity aerobic exercises with 50 to 60 % of Maximum Heart rate 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• hemi paretic patients with ischemic stroke. • Patient's age ranged from 40 to 60 years old from both genders. • Duration of illness not more than 24 months. • All patients had mild cognitive deficits in domains (memory, attention, orientation, perception and executive skills) according to montreal cognitive assessment. • Spasticity ranged from (one, one plus) according to the modified ashworth scale. • Degree of weakness in paretic limb muscles wasn’t less than (grade 2) according to group muscle test. • Medically and psychologically stable patients • Patient with recurrent stroke or hemi paretic due to other neurological causes rather than stroke. • Patients with non-removable metal in their heads. • Patients that use a cardiac pacemaker. • Medically unstable or uncooperative patients Middle Aged: 45 Year(s)-64 Year(s) 40 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 07/11/2023 Ethical committee at Faculty of physical therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
11 Ahmed El-Zayat st., Bein Alsarayat Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rehacom is a software package that helps to assess and train different cognitive deficits: RehaCom software (Hasomed, Magdeburg, Germany) is an intensive cognitive rehabilitation test that includes 32 assessment tasks for attention, memory and executive function. pre and post intervention 6 weeks
Primary Outcome EEG mapping: The EEG was recorded with a resolution of 12 bits, 0.5 and 35 Hz filters and 200 samples per second, using the Braintech 3.0 equipment (EMSA Equipamentos Médicos). Impedance was maintained below 10 K . The electrodes were placed according to the International 10–20 System, with the use of an additional two electrodes placed 1 cm below (left side) and above (right side) the external angle of the eyelid, with the objective of evaluating eye movements Pre and post intervention 6 weeks
Secondary Outcome Montreal cognitive assessment: Screening assessment used for cognitive assessment. It is widely used design for assessment of mild cognitive impairments. It takes approximately 10 min to complete.30-point cognitive screening instrument. It purports to assess different cognitive domains (short term memory, visuospatial ability, executive function, attention, concentration, working memory, language and orientation to time and place). pre and post intervention 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatients clinics at Faculty of physical therapy Cairo university 11 Ahmed El-Zayat St. Bein Al Sarayat, Dokki, Giza Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Physical Therapy Cairo University 11 Ahmed ElZayat St., Dokki Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical therapy Cairo University 11 Ahmed El Zayat St., Dokki Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Moursy Termazy2030@yahoo.com +201144396027 11 ahmed el zayat St
City Postal code Country Position/Affiliation
Giza Egypt Physical Therapist
Role Name Email Phone Street address
Public Enquiries Abdelalim Atia Abdelalim.atia@yahoo.com +201007098435 11 ahmed el-zayat st
City Postal code Country Position/Affiliation
Giza Egypt Retired Professor Faculty of physical therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Hoda Zakaria Dr_hodazakaria@yahoo.com +201013107750 11 ahmed el-zayat st
City Postal code Country Position/Affiliation
Giza Egypt Professor Faculty of physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Noura Elkafrawy noura.elkafrawy@pt.cu.edu.eg +201066366879 11 Ahmed El-Zayat St.
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy for Neurology
Role Name Email Phone Street address
Principal Investigator Mye Basheer Mye.basheer@kasralainy.edu.eg +201001777179 Kasr al aniny St.
City Postal code Country Position/Affiliation
Cairo Egypt Professor of neurology Department of Neurology Faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of Individual Participant Data (IPD) collected during the trial , After deidentification will be shared for research purposes only Informed Consent Form data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Only Researchers in the project can see the data
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