The Effects of Vestibular Exercise and Cervical Stabilization Exercise Training on Balance and Gait in MS Patients

January 18, 2023 updated by: Hakan Polat, Sanko University

Comparison of the Effects of Vestibular Exercise and Cervical Stabilization Exercise Training on Balance and Gait in Multiple Sclerosis Patients

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,

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Group 1: Vestibular exercise training will be given in addition to conventional treatment (including TENS, electrical stimulation and normal joint range of motion exercises) for 12 weeks. Cawthorne-Cooksey Exercises will be given as a treatment protocol for vestibular exercise training.

Group 2 :Cervical stabilization exercise training will be given in addition to conventional treatment (including Tens, electrical stimulation and normal range of motion exercises) for 12 weeks. Cervical stabilization training improves the sense of cervical proprioception as well as strength and endurance, thereby reducing joint position sense error. Cervical stabilization exercises and training, consisting of 3 stages with increasing difficulty level, will be applied.

Group3: Classical balance exercise training will be given to the control group in addition to conventional treatment (including Tens, electrical stimulation and normal range of motion exercises) for 12 weeks. These exercises were selected among the exercises routinely used in balance rehabilitation in the literature and clinic.

Balance exercise program: walking on tiptoe and heel, walking straight and diagonally on the line, standing on a balance board, supine/prone rolling on the rehabilitation ball, pelvis control in the sagittal and frontal planes on the rehabilitation ball, prone balance on the rehabilitation ball, walking on mats of different softness , was created from side walking exercises.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Şehitkamil
      • Gaziantep, Şehitkamil, Turkey, 27500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vestibular Exercises
Cawthorne-Cooksey Exercises applied to 1st group for 3 days/week for 12 weeks
Exercises
Active Comparator: Cervical Stabilization Exercises
cervical stabilization Exercises applied to 1st group for 3 days/week for 12 weeks
Exercises
Active Comparator: Balance Exercises
classical balance Exercises applied to 1st group for 3 days/week for 12 weeks
Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static Balance
Time Frame: 12 weeks
functional reach test
12 weeks
Gait speed
Time Frame: 12 weeks
25-step walking test
12 weeks
Dizziness
Time Frame: 12 weeks
dizziness disability inventory
12 weeks
Dinamic Balance
Time Frame: 12 weeks
tandem stance test
12 weeks
Dinamic Balance
Time Frame: 12 weeks
4 square step test
12 weeks
Endurance
Time Frame: 12 weeks
2-minute walk test
12 weeks
Coordination
Time Frame: 12 weeks
timed sit and stand test
12 weeks
Postural swing
Time Frame: 12 weeks
GYKO
12 weeks
Walkiing difficulty
Time Frame: 12 Weeks
Multiple Sclerosis Walking Scale-12 (MSYS-12)
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: 12 weeks
fatigue impact scale
12 weeks
Depression
Time Frame: 12 weeks
beck depression inventory
12 weeks
MSQ54 İnventory
Time Frame: 12 weeks
quality of life
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: hakan Polat, SANKO University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

January 25, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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