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

Primary Purpose

Multiple Sclerosis, Vestibular, Exercises

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercises
Sponsored by
Sanko University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, vestibular exercises, cervical stabilization, gait

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanko UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Vestibular Exercises

Cervical Stabilization Exercises

Balance Exercises

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fatigue
fatigue impact scale
Depression
beck depression inventory
MSQ54 İnventory
quality of life

Full Information

First Posted
April 8, 2022
Last Updated
January 18, 2023
Sponsor
Sanko University
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1. Study Identification

Unique Protocol Identification Number
NCT05409599
Brief Title
The Effects of Vestibular Exercise and Cervical Stabilization Exercise Training on Balance and Gait in MS Patients
Official Title
Comparison of the Effects of Vestibular Exercise and Cervical Stabilization Exercise Training on Balance and Gait in Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
January 25, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanko 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 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,
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Vestibular, Exercises
Keywords
Multiple Sclerosis, vestibular exercises, cervical stabilization, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Exercises
Arm Type
Active Comparator
Arm Description
Cawthorne-Cooksey Exercises applied to 1st group for 3 days/week for 12 weeks
Arm Title
Cervical Stabilization Exercises
Arm Type
Active Comparator
Arm Description
cervical stabilization Exercises applied to 1st group for 3 days/week for 12 weeks
Arm Title
Balance Exercises
Arm Type
Active Comparator
Arm Description
classical balance Exercises applied to 1st group for 3 days/week for 12 weeks
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
Exercises
Primary Outcome Measure Information:
Title
Static Balance
Description
functional reach test
Time Frame
12 weeks
Title
Gait speed
Description
25-step walking test
Time Frame
12 weeks
Title
Dizziness
Description
dizziness disability inventory
Time Frame
12 weeks
Title
Dinamic Balance
Description
tandem stance test
Time Frame
12 weeks
Title
Dinamic Balance
Description
4 square step test
Time Frame
12 weeks
Title
Endurance
Description
2-minute walk test
Time Frame
12 weeks
Title
Coordination
Description
timed sit and stand test
Time Frame
12 weeks
Title
Postural swing
Description
GYKO
Time Frame
12 weeks
Title
Walkiing difficulty
Description
Multiple Sclerosis Walking Scale-12 (MSYS-12)
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Fatigue
Description
fatigue impact scale
Time Frame
12 weeks
Title
Depression
Description
beck depression inventory
Time Frame
12 weeks
Title
MSQ54 İnventory
Description
quality of life
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Polat
Phone
05386487265
Email
hakan.polat@sanko.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hakan Polat
Organizational Affiliation
Sanko University
Official's Role
Study Director
Facility Information:
Facility Name
Sanko University
City
Gaziantep
State/Province
Şehitkamil
ZIP/Postal Code
27500
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hakan polat
Phone
05386487265
Email
hakan.polat@sanko.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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