- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05409599
The Effects of Vestibular Exercise and Cervical Stabilization Exercise Training on Balance and Gait in MS Patients
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
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hakan Polat
- Phone Number: 05386487265
- Email: hakan.polat@sanko.edu.tr
Study Locations
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Turkey, 27500
- Recruiting
- SANKO University
-
Contact:
- Hakan Polat
- Phone Number: 05386487265
- Email: hakan.polat@sanko.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Study Director: hakan Polat, SANKO University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HakanP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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