Protocol summary

Study aim
Effect of cognitive-motor dual task training on somatosensory, balance, activity of daily living and community integration in patient with relapsing-remitting Multiple sclerosis
Design
A prospective study of a blind clinical trial with two parallel, randomized groups
Settings and conduct
The samples are selected from the clients of the Multiple Sclerosis Society of Isfahan and randomly divided into two groups. Before the randomization, patients are described, which will be divided into two groups with two different programs. After obtaining patient consent and collecting demographic data, EDSS will be used to diagnose patients' incapacity. Clients, the person who evaluates, and the person who performs the rehab program do not know the type of group (intervention, control).
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of multiple sclerosis, EDSS 2-5/5, Ability to stand without any support, Having a sensory problem on the soles of the foot ,Remitting during the last 30 days, Having the ability to read and write, The doctor confirmed to participate in research Exclusion criteria: People with diseases such as diabetes, epilepsy and with any problem in the musculo-skeletal system: History of surgery, History of fractures, and ... that disturbs the balance, Receive corticosteroid treatment one month before the study, MMSE-less than 24, Uncorrected visual disorders, Relapsing, Inability to walk a distance of 25 feet with or without assistive device
Intervention groups
Intervention group: cognitive-motor dual task training control group: balance training
Main outcome variables
Intervention(cognitive-motor dual task training): independent variable Somatosensory: dependent variable Balance: dependent Community integration: dependent Instrumental activity of daily living: dependent Activity of daily living: dependent

General information

Reason for update
Acronym
Dual Task Training DTT
IRCT registration information
IRCT registration number: IRCT20180523039792N1
Registration date: 2019-06-13, 1398/03/23
Registration timing: registered_while_recruiting

Last update: 2019-06-13, 1398/03/23
Update count: 0
Registration date
2019-06-13, 1398/03/23
Registrant information
Name
Shirin Saberimobarake
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5229
Email address
shirin.saberi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dual task training on somatosensory, balance, activity of daily living and Community participation in patient with relapsing-remitting Multiple sclerosis: Double Blind Clinical Trial
Public title
Effect of dual task training on somatosensory, balance, Community participation and activity of daily living in Multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Neurologist EDSS Score 2-5/5(To be able to complete walking tests) Ability to stand without any support Having a sensory problem on the soles of the foot relapsing During the last 30 days Having the ability to read and write The doctor confirmed to participate in research
Exclusion criteria:
Diseases such as diabetes, epilepsy and ... Any problem in the musculoskeletal system: history of surgery, history of fractures, etc., which disturbs the balance. Corticosteroid treatment one month before the study MMSE less than 24 Uncorrected visual disorders Exacerbation of symptoms Inability to walk 25 ft with or without assisstive device Major depression
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Method: Restricted Randomization by random allocation rule method: first, a sample size determine and then randomly assign a set of them to Group A and assign the remainder to Group B. Random unit: Individual Non-transparent envelopes are used to hide random assignments In this method, first, a random sequence is created using the above method. Then, based on the sample size of the research, a number of envelopes with an aluminum wrapper (in order to avoid the clarity of the contents of the envelopes) are prepared and each random sequence created on a card is recorded and the cards is placed inside the envelopes. At the time of the start of the registration of the participants, one of the envelopes shall be opened in accordance with the order of entry of the eligible participants, and the group allocated to that participant shall be revealed. Process execution:One person will create a random sequence, the other will examine the participants in terms of inclusion and exclusion criteria and enroll them in the study, and the third person will assign the participants to the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant will be notified in two groups whose programs are different. Practitioners who train the intervention program do not know about the intervention and control group program.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical sciences
Street address
Isfahan university of medical sciences, Hezarjrib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.314

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
Somatosensory
Timepoint
Before the intervention, immediately after the intervention, one week after the end of the intervention
Method of measurement
monofilament

2

Description
Balance
Timepoint
Before the intervention, immediately after the intervention, one week after the end of the intervention
Method of measurement
Berg balance scale

3

Description
Balance
Timepoint
Before the intervention, immediately after the intervention, one week after the end of the intervention
Method of measurement
Force plate

Secondary outcomes

1

Description
Activities of daily living (basic, instrumental)
Timepoint
Before the intervention, immediately after the intervention, one month after the end of the intervention
Method of measurement
Barthel index score Lawton instrumental activity of daily living

2

Description
Community integration
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
Community integration Questionnaire

Intervention groups

1

Description
Intervention group: Dual cognitive-motor exercises. At the beginning of the session, warm-up exercises are performed for 10 minutes, then balanced exercises begin. Each exercise consists of 2 courses, depending on the person's level of ability, each course performed one to two minutes and for repetitive exercises 10 to 15 repetitions. The rest time between each period is also 1 to 2 minutes. The intervention group performs the second cycle exercises with cognitive activity. At the end, the cooling exercises will take about 10 minutes.
Category
Rehabilitation

2

Description
Control group: Dual cognitive-motor exercises. At the beginning of the session, warm-up exercises are performed for 10 minutes, then balanced exercises begin. Each exercise consists of 2 courses, depending on the person's level of ability, each course performed one to two minutes and for repetitive exercises 10 to 15 repetitions. The rest time between each period is also 1 to 2 minutes. At the end, the cooling exercises will take about 10 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan MS Society
Full name of responsible person
Shirin Saberimobarake
Street address
No. 2, Behesht Building (Ground Floor)., Opposite the Al-Kareem Mosque., Bozorgmehr Street
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۵-۱۶۴
Phone
+98 31 3792 5229
Email
shirin.saberi69@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Yousef Gheysari
Street address
Faculty of Rehabilitation Sciences., Isfahan University of Medical Sciences., Hezarjrib Street
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5229
Email
shirin.saberi69@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Saberimobarake
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Musculoskeletal research center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jrib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5229
Fax
Email
shirin.saberi69@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Saberimobarake
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Musculoskeletal research center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jrib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5229
Fax
Email
shirin.saberi69@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Saberimobarake
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Musculoskeletal research center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jrib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5229
Fax
Email
shirin.saberi69@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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