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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05409599
Other study ID # HakanP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date February 1, 2023

Study information

Verified date January 2023
Source Sanko University
Contact Hakan Polat
Phone 05386487265
Email hakan.polat@sanko.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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,


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date February 1, 2023
Est. primary completion date January 25, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Exercises
Exercises

Locations

Country Name City State
Turkey Sanko University Gaziantep Sehitkamil

Sponsors (1)

Lead Sponsor Collaborator
Sanko University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Static Balance functional reach test 12 weeks
Primary Gait speed 25-step walking test 12 weeks
Primary Dizziness dizziness disability inventory 12 weeks
Primary Dinamic Balance tandem stance test 12 weeks
Primary Dinamic Balance 4 square step test 12 weeks
Primary Endurance 2-minute walk test 12 weeks
Primary Coordination timed sit and stand test 12 weeks
Primary Postural swing GYKO 12 weeks
Primary Walkiing difficulty Multiple Sclerosis Walking Scale-12 (MSYS-12) 12 Weeks
Secondary Fatigue fatigue impact scale 12 weeks
Secondary Depression beck depression inventory 12 weeks
Secondary MSQ54 Inventory quality of life 12 weeks
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