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Clinical Trials/NCT05526287
NCT05526287CompletedNot Applicable

Effects of Dual-Task Training on Balance, Gait, Dual-Task Performance, Cognitive Function, Fatigue in People With Multiple Sclerosis

Ege University1 site in 1 country26 target enrollmentStarted: November 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Timed Up And Go Test (TUG)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Dual-Task Group

Experimental

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.

Intervention: Dual-Task Training (Other)

Control Group

Active Comparator

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: Home Exercise Program (Other)

Outcomes

Primary Outcomes

Timed Up And Go Test (TUG)

Time Frame: eight weeks

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

Time Frame: eight weeks

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.

Berg Balance Scale(BBS)

Time Frame: eight weeks

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.

Secondary Outcomes

  • Dual-Task Questionnaire(DTQ)(eight weeks)
  • MS Walking Scale-12(MSWS-12)(eight weeks)
  • 10 Meter Walking Test(10MWT)(eight weeks)
  • Fatigue Severity Index(FSI)(eight weeks)
  • Dual-Task Performance(eight weeks)
  • Brief International Cognitive Assesment for MS(BICAMS)(eight weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Ozkeskin

Assistant Professor

Ege University

Study Sites (1)

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