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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202406712978844 Date of Registration: 04/06/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of adding feedback training to cognitive behavioral therapy on functional outcome in patients with multiple sclerosis
Official scientific title Effect of adding feedback training to cognitive behavioral therapy on functional outcome in patients with multiple sclerosis
Brief summary describing the background and objectives of the trial Background: Multiple Sclerosis (MS) is a central nervous system demyelinating disease which causes different neurological manifestations. Depression and impairment of functional outcomes are major clinical manifestations in MS patients. Objective: To assess the efficacy of adding neurofeedback training to cognitive behavioral therapy on functional outcomes in patients with multiple sclerosis.
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 15/11/2022
Actual trial start date 15/11/2022
Anticipated date of last follow up 20/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants)
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
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 Neurofeedback training added to cognitive behavioral therapy and conventional physical therapy Three times per week for one month 60 Min. to 90 Min. CBT is a talking therapy that can help you manage your problems by changing the way you think and behave. Feed back is adding the Mobile Phone during CBT: This phone was connected by Bluetooth to Virtual Reality glasses (it was used as a tool for feedback training) with selected videos on it to give a feedback about the behavior and thinking . Conventional therapy includes strengthening , stretching , and functional training according to each patient. 17
Control Group Cognitive behavior therapy and conventional therapy three times per week for one month 60 Min. to 90 Min. CBT is a talking therapy that can help you manage your problems by changing the way you think and behave. Conventional therapy includes strengthening , stretching , and functional training according to each patient. 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1)Thirty four patients from both sexes diagnosed with Multiple sclerosis according to revised McDonald criteria 2017. 2)The age ranged from 25 to 35 years old. 3)Clinical types of MS; remitting relapsing MS (RRMS) and secondary progressive MS (SPMS). 4)Patients with no relapses in the last three months prior to the study. 5)All Patients suffer from mild to moderate depression according to Beck depression inventory 6)Duration of illness ranged from five to 15 years and EDSS is less than 6.5 ( 7)Patients can walk alone or at least with assistive devices (cane). 8)Patients have normal vision and hearing. 1-Concomitant neurological or psychiatric disorders causing depression. 2-Orthopedic disorders overlapping neurological weakness and interfering with walking or upper limb functions. 3-History of previous brain surgery. 4-Immobility (wheel chair) or bed ridden. 5-Participants who take any medication that affect mood or cognition (major tranquilizers or mood stabilizers as antidepressants). Adult: 18 Year(s)-44 Year(s) 25 Year(s) 35 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 02/08/2022 Ethical Committee at Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
11 Ahmed El-Zayat Street Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression using beck depression inventory pre and post intervention
Secondary Outcome Functional outcomes using 25-feet walk test for lower limb. pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Labs of Faculty of Physical Therapy Cairo University 11 Ahmed El-Zayat street Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of physical therapy Cairo University 11 Ahmed El-Zayat Street Giza 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 Street Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mai Shehab mairabee050@gmail.com 00201155432017 11 Ahmed El-Zayat street
City Postal code Country Position/Affiliation
Giza Egypt Physical therapist in the ministry of health
Role Name Email Phone Street address
Public Enquiries Ebtesam Fahmy em_fahmy@kasralainy.edu.eg 00201002007077 5 handosa street , al manial , al kasr al ainy
City Postal code Country Position/Affiliation
Cairo Egypt Professor of neurology
Role Name Email Phone Street address
Scientific Enquiries Shaimaa Abdelmageed Shaimaa.Abdelmageed@pt.cu.edu.eg 00201028202856 11 Ahmed El-Zayat Street
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of faculty of physical therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Nagwa Ebrahim Nagwa1102010@yahoo.com 00201008124920 11 Ahmed El-Zauat Street
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries ABDELALEEM ATTIA Mostafa.alsaid2020@gmail.com 00201286273379 11 Ahmed El-Zayat Street
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy Cairo University
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