NCT05526287

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

July 29, 2022

Last Update Submit

November 18, 2025

Conditions

Keywords

Multiple SclerosisBalanceGaitDual-TaskCognitive FunctionFunctional MobilityActivities of Daily Living

Outcome Measures

Primary Outcomes (3)

  • 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.

    eight weeks

  • 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.

    eight weeks

  • 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.

    eight weeks

Secondary Outcomes (6)

  • MS Walking Scale-12(MSWS-12)

    eight weeks

  • Fatigue Severity Index(FSI)

    eight weeks

  • Brief International Cognitive Assesment for MS(BICAMS)

    eight weeks

  • 10 Meter Walking Test(10MWT)

    eight weeks

  • Dual-Task Performance

    eight weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

Other: Dual-Task Training

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.

Other: Home Exercise Program

Interventions

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.

Dual-Task Group

Home exercise program includes lower extremity, core stability and balance exercises and will be performed three times a week.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Health Sciences

Izmir, Karsıyaka, 35575, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nur YUCEYAR, MD

    Ege University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 29, 2022

First Posted

September 2, 2022

Study Start

November 1, 2022

Primary Completion

April 1, 2023

Study Completion

August 15, 2023

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations