Back to resultsEffects of Dual-Task Training in People With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dual-Task Training
Home Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Balance, Gait, Dual-Task, Cognitive Function, Functional Mobility, Activities of Daily Living
Eligibility Criteria
Inclusion Criteria:
- Having a definitive diagnosis of MS according to the revised McDonald criteria
- Having Expanded Disability Status Scale score between 0-5.5
- No relapse in the last 30 days
- Having a Mini Mental Test score of 24 and above
- Being fluent in Turkish language
- No condition that prevents exercising
Exclusion Criteria:
- Being pregnant
- Presence of a neuro-musculoskeletal disease other than Multiple Sclerosis
- Having received physiotherapy for balance and gait disorders in the last 3 months
Sites / Locations
- Ege University Faculty of Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dual-Task Group
Control Group
Arm Description
Participants will receive 8 weeks of dual-task training twice a week and home exercise program.Dual-task training will include motor-motor and motor-cognitive dual-task activities.Home exercise program will include core and lower extremity exercises.Home exercises will be performed three times a week.
Participants will receive 8 weeks of home exercise program.Home exercise program will include core and lower extremity exercises.Home exercises will be performed three times a week.
Outcomes
Primary Outcome Measures
Berg Balance Scale(BBS)
BBS, evaluates daily activities including static sitting and standing balance, as well as transfers, turning, and picking up objects from the ground, in 14 items.Scoring is given as 0-4. It scores from 4 (normal performance) to 0 (not able to do the movement) according to the person's ability to do what is asked of them safely and independently. The total score is 56 points. 0-20 indicates high risk, 21-40 indicates medium risk, and 41-64 indicates low risk.
Timed Up And Go Test (TUG)
It is a frequently used test that evaluates functional mobility and dynamic balance. At the beginning of the test, individuals sit in a chair. A distance of 3 m is set in front of the patient. With the start command, the patient gets up from his seat and walks 3 m, turns around and walks back and sits. With the start command, the time until the moment of sitting on the chair is recorded in seconds.Shorter duration indicates better functional mobility.
Tetrax((Sunlight Medical Ltd, Israel),Computerized Static Posturography Device
Tetrax (Sunlight Medical Ltd, Israel) computerized posturography device consists of a platform system where data is collected, a computer and software system where data is processed and integrated. Participants will stand on the platform system in 8 different condition. Tetrax will be used to measure static balance and fall risk.
Secondary Outcome Measures
MS Walking Scale-12(MSWS-12)
MSWS-12 is a 12-item scale evaluating the effect of MS on person's walking ability. MSWS-12 is scored between 12-54. Higher scores indicate more negatively affected walking ability.
Fatigue Severity Index(FSI)
The scale consists of 9 questions and each question is graded over 7 points.FSI is scored between 0-63. Higher scores indicate more fatigue.
Brief International Cognitive Assesment for MS(BICAMS)
BICAMS includes Symbol Digit Modalities Test (SDMT), California Verbal Learning Test II (CVLT-II) and Brief Visuospatial Memory Test-Revised (BVMT-R). The total score is determined by summing the scores of the 3 tests. Battery will be used to evaluate cognitive function. Higher scores indicate better cognitive function.
10 Meter Walking Test(10MWT)
This test calculates the unassisted walking speed of individuals at a distance of 10 meters. In this test, the person will be asked to walk at their normal pace in a pre-measured 10 meter area.
Dual-Task Performance
Dual-Task performance will be measured with TUG-cognitive and 10MWT-motor. In TUG-cognitive,patient will be counting down by three from a number between 100 and 200 while performing Timed-Up and Go test. In 10MWT-motor,patient will be carrying a tray with 3 water filled 200 ml plastic glasses while walking a 10 m distance.Time will be measured. Longer time to complete task indicates lower dual-task performance.
Dual-Task Questionnaire(DTQ)
The Dual Task Questionnaire assesses the frequency of difficulties experienced by individuals with neurological injury or disease during activities of daily living that involve dual tasks. DTQ is scored between 0-40. Higher scores indicate more frequent dual-task difficulties.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05526287
Brief Title
Effects of Dual-Task Training in People With Multiple Sclerosis
Official Title
Effects of Dual-Task Training on Balance, Gait, Dual-Task Performance, Cognitive Function, Fatigue in People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effects of dual task training on balance, gait, dual-task performance, cognitive function, fatigue and functional mobility in people with Multiple Sclerosis(MS).
Detailed Description
Eligible participants will be randomized to dual-task group or control group. Dual-task group will receive 8 weeks of dual-task training twice a week and home exercise program. Control group will receive only home exercise program for 8 weeks. Each participant will be assessed before and after the 8 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Balance, Gait, Dual-Task, Cognitive Function, Functional Mobility, Activities of Daily Living
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dual-Task Group
Arm Type
Experimental
Arm Description
Participants will receive 8 weeks of dual-task training twice a week and home exercise program.Dual-task training will include motor-motor and motor-cognitive dual-task activities.Home exercise program will include core and lower extremity exercises.Home exercises will be performed three times a week.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants will receive 8 weeks of home exercise program.Home exercise program will include core and lower extremity exercises.Home exercises will be performed three times a week.
Intervention Type
Other
Intervention Name(s)
Dual-Task Training
Intervention Description
Dual-task training sessions include; walking on treadmill for 10-30 minutes and half of this walking period participants will perform cognitive tasks, cognitive tasks will be repeated on tandem stance position and single leg stance position other half of the session consists of motor-motor dual task activities and gait training on firm and soft surfaces.
Home exercise program includes lower extremity, core stability and balance exercises and will be performed three times a week.
Intervention Type
Other
Intervention Name(s)
Home Exercise Program
Intervention Description
Home exercise program includes lower extremity, core stability and balance exercises and will be performed three times a week.
Primary Outcome Measure Information:
Title
Berg Balance Scale(BBS)
Description
BBS, evaluates daily activities including static sitting and standing balance, as well as transfers, turning, and picking up objects from the ground, in 14 items.Scoring is given as 0-4. It scores from 4 (normal performance) to 0 (not able to do the movement) according to the person's ability to do what is asked of them safely and independently. The total score is 56 points. 0-20 indicates high risk, 21-40 indicates medium risk, and 41-64 indicates low risk.
Time Frame
eight weeks
Title
Timed Up And Go Test (TUG)
Description
It is a frequently used test that evaluates functional mobility and dynamic balance. At the beginning of the test, individuals sit in a chair. A distance of 3 m is set in front of the patient. With the start command, the patient gets up from his seat and walks 3 m, turns around and walks back and sits. With the start command, the time until the moment of sitting on the chair is recorded in seconds.Shorter duration indicates better functional mobility.
Time Frame
eight weeks
Title
Tetrax((Sunlight Medical Ltd, Israel),Computerized Static Posturography Device
Description
Tetrax (Sunlight Medical Ltd, Israel) computerized posturography device consists of a platform system where data is collected, a computer and software system where data is processed and integrated. Participants will stand on the platform system in 8 different condition. Tetrax will be used to measure static balance and fall risk.
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
MS Walking Scale-12(MSWS-12)
Description
MSWS-12 is a 12-item scale evaluating the effect of MS on person's walking ability. MSWS-12 is scored between 12-54. Higher scores indicate more negatively affected walking ability.
Time Frame
eight weeks
Title
Fatigue Severity Index(FSI)
Description
The scale consists of 9 questions and each question is graded over 7 points.FSI is scored between 0-63. Higher scores indicate more fatigue.
Time Frame
eight weeks
Title
Brief International Cognitive Assesment for MS(BICAMS)
Description
BICAMS includes Symbol Digit Modalities Test (SDMT), California Verbal Learning Test II (CVLT-II) and Brief Visuospatial Memory Test-Revised (BVMT-R). The total score is determined by summing the scores of the 3 tests. Battery will be used to evaluate cognitive function. Higher scores indicate better cognitive function.
Time Frame
eight weeks
Title
10 Meter Walking Test(10MWT)
Description
This test calculates the unassisted walking speed of individuals at a distance of 10 meters. In this test, the person will be asked to walk at their normal pace in a pre-measured 10 meter area.
Time Frame
eight weeks
Title
Dual-Task Performance
Description
Dual-Task performance will be measured with TUG-cognitive and 10MWT-motor. In TUG-cognitive,patient will be counting down by three from a number between 100 and 200 while performing Timed-Up and Go test. In 10MWT-motor,patient will be carrying a tray with 3 water filled 200 ml plastic glasses while walking a 10 m distance.Time will be measured. Longer time to complete task indicates lower dual-task performance.
Time Frame
eight weeks
Title
Dual-Task Questionnaire(DTQ)
Description
The Dual Task Questionnaire assesses the frequency of difficulties experienced by individuals with neurological injury or disease during activities of daily living that involve dual tasks. DTQ is scored between 0-40. Higher scores indicate more frequent dual-task difficulties.
Time Frame
eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having a definitive diagnosis of MS according to the revised McDonald criteria
Having Expanded Disability Status Scale score between 0-5.5
No relapse in the last 30 days
Having a Mini Mental Test score of 24 and above
Being fluent in Turkish language
No condition that prevents exercising
Exclusion Criteria:
Being pregnant
Presence of a neuro-musculoskeletal disease other than Multiple Sclerosis
Having received physiotherapy for balance and gait disorders in the last 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet OZKESKIN, PhD
Phone
+905056631833
Email
mehmet.ozkeskin99@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ece EKICI, BSc
Phone
+905300733826
Email
ekiciece@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nur YUCEYAR, MD
Organizational Affiliation
Ege University
Official's Role
Study Chair
Facility Information:
Facility Name
Ege University Faculty of Health Sciences
City
İzmir
State/Province
Karsıyaka
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MEHMET OZKESKIN, PhD
Phone
+905056631833
Email
mehmet.ozkeskin99@gmail.com
First Name & Middle Initial & Last Name & Degree
ECE EKICI, BSc
Phone
+905300733826
Email
ekiciece@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Dual-Task Training in People With Multiple Sclerosis
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