Protocol summary

Summary
The purpose of this double-blinded, randomized controlled trial study is to compare the effect of single task versus dual task balance training in patients with multiple sclerosis. Fifty patients with MS will be included in this study, if they have following criteria: relapsing-remitting type of MS, ability to stand and walk without assistive devices, maximum score of 53 on Berg Balance Scale, Expanded Disability Status Scale between 2 and 4/5 and Mini-Mental State Examination more than 24. Persons are ineligible for the study if they have an exacerbation of symptoms due to relapse within 2 months of the baseline measurement, steroid treatment within 3 months of the baseline measurement, any musculoskeletal or neurological conditions except MS limiting balance or gait and vertigo. Patients randomly assign in dual task balance training or single task balance training(control) group. Participants receive 45 minutes training session, 3 times a week for 4 weeks. The participants in the single-task training group receive balance activities under single-task conditions while participants in dual-task training group practice balance activities and performing cognitive tasks simultaneously. Outcome measures for assessing Various aspects of balance are force plate, Functional reach test, Timed Up and Go, 10 meter Walk gait speed, 2 Minute Walk, Berg Balance Scale, Activities Specific Balance Confidence and Functional Gait Assessment. All measures will be collected at baseline and at the end of training.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051917752N1
Registration date: 2014-06-16, 1393/03/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-16, 1393/03/26
Registrant information
Name
Saeideh Monjezi
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3101
Email address
negahban-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz,Jundishapur University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of single balance task versus dual balance-cognitive task training on balance performance in patients with multiple sclerosis
Public title
Effect of two types of exercises on balance performance in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: A definite diagnosis of MS, relapsing-remitting type, as diagnosed by a neurologist; Ability to stand without assistive devices; Ability to walking without assistive devices; Maximum score of 53 on the Berg Balance Scale; EDSS between 2 and 4/5; MMSE more than 24. Exclusion criteria: Experiencing an exacerbation of symptoms due to relapse within 2 months of the baseline measurement; Steroid treatment within 3 months of the baseline measurement; Any musculoskeletal or neurological conditions except MS limiting balance or gait; Uncorrected Auditory or visual impairment; Vertigo; Pregnancy; Involving in the other planned treatment; Using drugs which affecting balance or gait.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Science
Street address
Ground floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Postal code
6135715794
Approval date
2014-02-08, 1392/11/19
Ethics committee reference number
ajums.REC.1392.302

Health conditions studied

1

Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Static Balance
Timepoint
Baseline - After intervention (4th week)
Method of measurement
Force plate - Functional Reach test

2

Description
Dynamic Balance
Timepoint
Baseline - After intervention (4th week)
Method of measurement
Functional Gait Assessment- Timed Up and Go test (with and without Cognitive task) - 10 meter walk self selected gait speed (with and without Cognitive task) - 2 minute walk (with and without Cognitive task)

3

Description
Balance Confidence
Timepoint
Baseline - After intervention (4th week)
Method of measurement
Activities Specific Balance Confidence

4

Description
Functional Balance
Timepoint
Baseline - After intervention (4th week)
Method of measurement
Berg Balance Scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Perform Balance exercises (Single task training); Participants received 45-minute individualized (1 trainer to 1 participant) training sessions, 3 times a week for 4 weeks.
Category
Rehabilitation

2

Description
Intervention group: Perform Balance exercises and cognitive task simultaneously( Dual task training); Participants received 45-minute individualized (1 trainer to 1 participant) training sessions, 3 times a week for 4 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Zahra Najarzade
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Nader Saki
Street address
Ground floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ah
Full name of responsible person
Saeideh Monjezi
Position
MSc Student of Physical Therapy
Other areas of specialty/work
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1374 3101
Fax
Email
saeideh.monjezi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ah
Full name of responsible person
Saeideh Monjezi
Position
MSc Student of Physical Therapy
Other areas of specialty/work
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1374 3101
Fax
Email
saeideh.monjezi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ah
Full name of responsible person
Saeideh Monjezi
Position
MSc Student of Physical Therapy
Other areas of specialty/work
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1374 3101
Fax
Email
saeideh.monjezi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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