- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03670459
Forty Five Patients With Multiple Sclerosis Recieved Vestibular Rehabilitation and Balance Training
Cawthorne Cooksey Versus Vestibular Habituation Exercises on Trunk Kinetics and Velocity of Gait in Patients With Multiple Sclerosis
Patients with multiple sclerosis (MS) might develop dizziness or vertigo as a first manifestation or during the course of the illness. Many patients with MS experience chronic or intermittent dizziness. Acute symptoms of dizziness or vertigo in MS fall into two categories; acute vestibular syndrome (AVS) and positional vertigo.
Vestibular disorder due to MS decreases whole body dynamic postural control and causes many functional limitations as limitations in ambulation, dynamic balance and trunk control and that decreases the quality of life.
Vestibular dysfunction has long been recognized as causing some of the most common symptoms in MS, true vertigo is found at presentation in up to 17% of patients, several recent reports have suggested that vestibular symptoms develop early in the disease process. Vestibular Rehabilitation has been shown to be effective in reducing symptoms and improving function for patients with vestibular disorders. The goal of vestibular rehabilitation is to promote the central nervous system compensation through exercise-based strategies.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purposes of the study were to:
- Measure the effect of Cawthorne Cooksey Exercises on trunk kinetics and velocity of gait in patient with MS.
- Measure the effect of vestibular habituation on trunk kinetics and velocity of gait in patient with MS.
- Determine which type of vestibular exercises had more effect on the rehabilitation of patients with MS Cawthorne Cooksey or vestibular habituation?
- Determine if there was a correlation between the improvement in trunk kinetics and velocity of gait in patients with MS.
Forty five patients with multiple sclerosis were selected from the Out Patient Clinics of Neurology and Internal Medicine in Kasr Al- Aini Hospitals, Out Patient Clinic of Neurology, Faculty of Physical Therapy, Cairo University and 6th of October central hospital.
The selected patients were divided into three equal groups:
- Patients in G1 will receive traditional physical therapy program (balance training) for twelve sessions; day after day
- Patients in G2 will receive Cawthorne Cooksey Exercises in addition to traditional physical therapy program for twelve sessions; day after day.
- Patients in G3 will receive vestibular habituation exercises in addition to traditional physical therapy program for twelve sessions; day after day.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt, 12511
- October 6 University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All the Patients in this study will be referred from the neurologist and will be diagnosed as relapsing-remitting multiple sclerosis in the form of hemiparesis with muscle tone of 1,1+ modified Ashworth scale.
- The diagnosis will be confirmed by MRI or CT scan and all the patients will follow the neurological examination.
- Forty five female patients ages will range from 35-55 years.
- All selected patients with central vertigo (central vestibular disorder) according to Dix Hallpike test (Cohen, 2004)
- The Degree of disability of multiple sclerosis will be from 2 - 2.5 (according to expanded disability status scale (EDSS)) (Kaufman et al, 2000)
- All the selected patients will have grade 3 group muscle test of lower limb muscles.
- All the selected patients will have scored 27-30 in mini-mental state examination (Crum et al, 1993)
- Patients who are selected in the study will be ambulant.
- Patients will be medically stable.
Exclusion Criteria:
- Patients with musculoskeletal deformity.
- Patients with diabetes mellitus.
- Patients with psychological disturbance or seizures.
- Patients with visual or impairment.
- Patients with inner ear disorders
- Patients with other neurological disorders such as cerebellar lesion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Patients in G1 will receive traditional physical therapy program (balance exercises) for twelve sessions; day after day
|
Weight Shift Forward and Back
|
|
Experimental: Group 2
Patients in G2 will receive Cawthorne Cooksey Exercises in addition to traditional physical therapy program for twelve sessions; day after day .
|
Eye movements and head movements
|
|
Experimental: Group 3
Patients in G3 will receive vestibular habituation exercises in addition to traditional physical therapy program for twelve sessions; day after day.
|
Move from a sitting position to flat on the back
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isokinetic dynamometer
Time Frame: up to 30 days
|
Assessment of trunk kinetics
|
up to 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hosam Magdy Metwally, Doctoral, October 6 University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Identifier No. 11
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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