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.: PACTR202103587471967 Date of Approval: 03/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of dual task on balance of multiple sclerosis patients
Official scientific title Effect of dual task on balance of multiple sclerosis patients
Brief summary describing the background and objectives of the trial Multiple Sclerosis is associated with executive dysfunction and postural impairments and affects quality of life in 85% of patients. Balance dysfunction represents one of the earliest reported symptoms in MS patients, being announced even in the absence of clinical disability (Michelle et al., 2018). Doty and colleagues in 2018 mentioned that cerebellar and brainstem lesions were found to correlate with poor performance on static balance tests. In earlier work, volumes of demyelination within the brainstem, cerebellum and spinal cord were correlated with the length and velocity of static weight shifts on a balance platform. The negative physical and psychological impact of repeated and unexpected falls in patients with MS has led to falls risk detection and prevention becoming a rapidly developing research area in rehabilitation for MS patients. Moreover, recent evidence showed that balance in individuals with MS can be negatively affected by adding of a concurrent secondary task (i.e. dual task).Based on that, examining the performance of dual-task activity (i.e., performing two or more tasks concurrently) is considered one model for early assessing balance control in MS patients and the effects of increased demands on cognitive resources that is manifested as executive dysfunction in MS patients. (Fujita et al., 2016). Additional motor tasks can be considered as a means to increase task complexity without being challenged by literacy levels, language or speech problems that usually impact the use of cognitive tasks as an additional task .Only few randomized control trials have evaluated the effects of motor dual task on balance in ataxic MS patients (Mercan et al., 2016). So, the importance and strength of this study is to assess the effects of motor dual task on balance of ataxic MS patients which can interfere with many activities of daily living (ADLs) and as a consequence their rehabilitation program can be precisely and appropriately planned.
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 01/09/2020
Actual trial start date 01/09/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC/012/002860
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dual tasks 30 sec / 6 times coin transfer task: transfer coins from pocket to another holding tray task : holding a tray with empty plastic cups upon 30
Control Group single task 30 sec / 3 trials 3 trials static standing 30 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Definite diagnosis of relapsing-remitting multiple sclerosis of ataxic type, fulfilled the Revised McDonald's criteria for diagnosis of multiple sclerosis 2010 (Polman et al., 2011).  A score of 1.0 to 4.0 on the Expanded Disability Status Scale (EDSS).  A score of 30 to 26 in Montreal Cognitive Assessment (MoCA).  Age ranged from 30 – 40 years old.  All patients were in the remission period.  Last attack occurred at least in the past two months.  All Patients were ambulant.  Patients were medically stable.  Ability to understand and follow instructions.  Patients were free from any secondary complications such as contractures or deformities.  Patients signed informed consent. • Any other neurological deficits or orthopedics abnormalities preventing participation in the study. • Patients who have any other inflammatory or infectious diseases, e.g. arthritis. • Pregnant female patients. • Cardiovascular and Pulmonary diseases. • Patients with active or uncontrolled pathologies (i.e. cancer, hypertension). • Patients with severe cognitive deficits. • Patients with any psychiatric disease. • History of seizure. Adult: 19 Year-44 Year 30 Year(s) 40 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 09/09/2020 Research ethical committee faculty of physical therapy cairo University
Ethics Committee Address
Street address City Postal code Country
zayat st - dokki - egypt cairo 0020 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome balance indices from Biodex Balance System Antero posterior stability index , Mediolateral stability index , overall stability index
Secondary Outcome Timed up and Go test TUG Time needed to complete tests
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
multiple sclerosis unit at Kasr eleiny hospital Al sayda zeinab - kasr alainy hospital - cairo - egypt cairo 0020 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Basant hegazy cairo-egypt cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self dokki dokki Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abdelaziz Abdelaziz elsherif Dokki- cairo-egypt Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator USAMA RASHAD Physiotherapistbasant@gmail.com 00201010855200 DOKKI
City Postal code Country Position/Affiliation
CAIRO Egypt Professor of physio therapy
Role Name Email Phone Street address
Public Enquiries usama rashad physiotherapistbasant@gmail.com 00201010855200 dokki
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Scientific Enquiries usama rashad physiotherapistbasant@gmail.com 00201010855200 dokki
City Postal code Country Position/Affiliation
cairo Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual data will be available ,all data not available Informed Consent Form,Statistical Analysis Plan not applicable not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicable Yes 27/02/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/03/2021 Result - 02/03/2021 Result - 02/03/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information