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.: PACTR202311670782148 Date of Approval: 21/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Vestibular training on cognitive functions in multiple sclerosis patients.
Official scientific title Effect of vestibular training on cognitive functions and central fatigue in multiple sclerosis patients.
Brief summary describing the background and objectives of the trial Background: The vestibular system has traditionally been thought of as a balance apparatus. A growing body of literature suggests an association between vestibular function and cognitive functions in health and disease. Central vestibular functions are associated with multiple domains of cognition in people with MS even when controlling for disability status. These correlations suggest that both central vestibular dysfunction and cognitive dysfunction in people with MS are driven by pathology of shared neurological pathways. To our knowledge, the effectiveness of vestibular rehabilitation on improving the cognition and central fatigue in MS patients has never been explored. Therefore, we will postulate that vestibular rehabilitation would be an effective approach to the improvement of both cognition and central fatigue in patients with MS. objectives: - To investigate the influence of vestibular rehabilitation on cognitive functions and central fatigue in multiple sclerosis patients. - To determine the relationship between central vestibular integration, cognition, and primary fatigue in multiple sclerosis 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 05/02/2023
Actual trial start date 01/04/2023
Anticipated date of last follow up 15/10/2023
Actual Last follow-up date 02/11/2023
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Ethical Committee of Faculty of Physical Therapy, Cairo University
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 Permuted block randomization Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Designed vestibular rehabilitation therapy in addition to aerobic endurance exercises. Three times per week regularly. Four successive weeks. A standardized vestibular rehabilitation program in addition to 15-minute session of aerobic exercises in form of endurance exercise by a stationary bicycling. Vestibular rehabilitation therapy (VRT) consisted of eye movement and upright postural control exercises. Eye movement exercises included visual fixation through training of vestibulo-ocular reflex, saccadic eye movements and visual tracking of a moving object in a horizontal, vertical and diagonal directions. Upright postural control exercises included balance training from standing with different sensory input, changing body positions and from walking. Each item was performed for 1 to 2 minutes with a total 40 minutes for the whole VRT with time for rest in between each exercise. 20
Control Group Aerobic exercises in form of endurance exercise by a stationary bicycling Three times per week regularly. Four successive weeks The treatment session included 5-minute warm up, two 15-minute sessions and 5-minute cool-down. The training intensity during the 15-minute sessions was 65% to 75% of maximal heart rate. The level of intensity and duration of cycling are based on the typical capacity of individuals with MS 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Remitting relapsing multiple sclerosis (RRMS) patients who have no relapses over the past three months.  Duration of illness had started not more than ten years.  Age ranged from 20 to 45 years old.  Body mass index (BMI) ranged from 18.5 to 24.9 kg/m2.  Mini Mental State Examination (MMSE) score ≥ 26.  All the patients were ambulant with mild to moderate disability according to expanded disability status scale (EDSS) ≤ 5.  Primary fatigued MS patients complained from fatigue for more than two months with total score of Fatigue severity scale (FSS) ≥ 36.  All the patients educated with at least primary level of education.  Hamilton depression rating scale score (HDRS 17) ≤ 7.  Sleep disturbances with Epworth sleepiness scale (ESS) ≥ 12.  Severe visual or auditory impairment.  Diseases that may affect cognitive functions such as hypertension, diabetes mellitus, connective tissue disorders, thyroid disorders, renal or hepatic impairment.  Peripheral vestibulopathy.  Patients on medications as glucocorticoids, amantadine, betaferon, hypnotics and modafinil.  Previous history of any orthopedic problem. Adult: 19 Year-44 Year 20 Year(s) 45 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 of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
Ahmed Elzayat street, Bien Elsaryat Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Brain-derived neurotrophic factor (BDNF): As a family of proteins, neurotrophic factors, or “growth factors”, are directly involved in neuronal and synaptic growth. The BDNF protein is vital for cognitive performance in the short-term and for adaptations in brain morphology (e.g., plasticity) in the long-term. Indeed, the importance of BDNF for cognitive performance is a line of research that has been given a great amount of attention. Blood samples were taken from patients and controls to measure the serum level of brain-derived neurotrophic factor (BDNF). Pre-treatment and post-treatmment
Secondary Outcome - Pro-inflammatory cytokine tumor necrosis factor-α (TNF-α): Central fatigue is related to an increased level of pro-inflammatory cytokines, especially TNF-α. Pre-treatment and post- treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elkasr ElAini Multiple sclerosis unit Faculty of Medicine Cairo University Al-Saray Street, El Manial Cairo 11956 Egypt
Outpatient clinic of Physical therapy for Neurology Faculty of Physical Therapy Cairo University Ahmed Elzzyat street, Bien Elsseryat Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No Fund No Fund No Fund Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University Ahmed Elzayat Street, Bien Elsaryat Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Moshera H. Darwesh Ahmed Elzyat Street, Bien Elsaryat Giza 12612 Egypt
Prof. Dr. Mohamed S. ElTamawy Al-Saray Street, El Manial Cairo 11956 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Manar Elsayed Ismail elmanar.ismail@gmail.com +236717691 Ahmed Elzayat street, Bien Elsaryat
City Postal code Country Position/Affiliation
Giza 12612 Egypt Associate Lecturer of Physical Therapy For Neurology Cairo University
Role Name Email Phone Street address
Public Enquiries Manar Elsayed Ismail elmanar.ismail@gmail.com +236717691 Ahmed Elzayat street, Bien elsaryat
City Postal code Country Position/Affiliation
Giza 12612 Egypt Associate Lecturer of Physical Therapy For Neurology Cairo University
Role Name Email Phone Street address
Scientific Enquiries Manar Elsayed Ismail elmanar.ismail@gmail.com +236717691 Ahmed Elzayat street, Bien Elsaryat
City Postal code Country Position/Affiliation
Giza 12612 Egypt Associate Lecturer of Physical Therapy For Neurology Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in neurological rehabilitation. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Summary results or a link to summary results within the trial registration record will be done within 12 months of the study completion date. Informed Consent Form 12 months controlled, Quality of request
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