NCT05409599

Brief Summary

The population of this research consists of individuals between the ages of 18-65 with MS disease. MS patients to be included in the study will be directed by the Neurology outpatient clinic of Sanko University Hospital. All volunteers who agreed to participate in this randomized controlled pretest-posttest design study and met the sample criteria will be included in the study.Individuals who agree to participate will be divided into three groups by simple random method and closed envelope method. Vestibular exercise training group will be formed as Group 1 and Cervical stabilization exercise training group as Group 2, control group, and Group 3 as control group.Functional reach test, tandem stand test, 25 step walking test scale form, Multiple Sclerosis Quality of Life Scale form ( MSQOL-54),Fatigue Impact Scale,Beck depression inventory, MS walking scale (msys-12), dizziness disability inventory, four step square test, timed sit and stand test , 2 minutes walking test be performed before and after treatment,

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

April 8, 2022

Last Update Submit

January 18, 2023

Conditions

Multiple SclerosisVestibularExercises

Keywords

Multiple Sclerosisvestibular exercisescervical stabilizationgait

Outcome Measures

Primary Outcomes (9)

  • Static Balance

    functional reach test

    12 weeks

  • Gait speed

    25-step walking test

    12 weeks

  • Dizziness

    dizziness disability inventory

    12 weeks

  • Dinamic Balance

    tandem stance test

    12 weeks

  • Dinamic Balance

    4 square step test

    12 weeks

  • Endurance

    2-minute walk test

    12 weeks

  • Coordination

    timed sit and stand test

    12 weeks

  • Postural swing

    GYKO

    12 weeks

  • Walkiing difficulty

    Multiple Sclerosis Walking Scale-12 (MSYS-12)

    12 Weeks

Secondary Outcomes (3)

  • Fatigue

    12 weeks

  • Depression

    12 weeks

  • MSQ54 İnventory

    12 weeks

Study Arms (3)

Vestibular Exercises

ACTIVE COMPARATOR

Cawthorne-Cooksey Exercises applied to 1st group for 3 days/week for 12 weeks

Other: Exercises

Cervical Stabilization Exercises

ACTIVE COMPARATOR

cervical stabilization Exercises applied to 1st group for 3 days/week for 12 weeks

Other: Exercises

Balance Exercises

ACTIVE COMPARATOR

classical balance Exercises applied to 1st group for 3 days/week for 12 weeks

Other: Exercises

Interventions

ExercisesOTHER

Exercises

Balance ExercisesCervical Stabilization ExercisesVestibular Exercises

Eligibility Criteria

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

You may qualify if:

  • be diagnosed with MS
  • Not having received physiotherapy-oriented treatment in the last 1 year
  • not have had an attack in the last 1 month and not be in the attack period

You may not qualify if:

  • having systemic diseases such as hypertension, heart disease, diabetes mellitus, hyperlipidemia, malignancy
  • individuals whose ambulation is not independent
  • Those who have undergone any surgery in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko University

Gaziantep, Şehitkamil, 27500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • hakan Polat

    Sanko University

    STUDY DIRECTOR

Central Study Contacts

Hakan Polat

CONTACT

05386487265hakan.polat@sanko.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 8, 2022

First Posted

June 8, 2022

Study Start

October 1, 2021

Primary Completion

January 25, 2023

Study Completion

February 1, 2023

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)