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Forty Five Patients With Multiple Sclerosis Recieved Vestibular Rehabilitation and Balance Training

Primary Purpose

Neurologic Disorder

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Cawthorne Cooksey exercises

Vestibular habituation exercises

Balance exercises

About this trial

This is an interventional treatment trial for Neurologic Disorder

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

October 6 University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Patients in G1 will receive traditional physical therapy program (balance exercises) 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.

Outcomes

Primary Outcome Measures

Isokinetic dynamometer

Assessment of trunk kinetics

Secondary Outcome Measures

Full Information

NCT ID

NCT03670459

First Posted

September 7, 2018

Last Updated

September 11, 2018

Sponsor

October 6 University

1. Study Identification

Unique Protocol Identification Number

NCT03670459

Brief Title

Forty Five Patients With Multiple Sclerosis Recieved Vestibular Rehabilitation and Balance Training

Official Title

Cawthorne Cooksey Versus Vestibular Habituation Exercises on Trunk Kinetics and Velocity of Gait in Patients With Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

December 31, 2017 (Actual)

Primary Completion Date

July 21, 2018 (Actual)

Study Completion Date

September 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

October 6 University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurologic Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Patients in G1 will receive traditional physical therapy program (balance exercises) for twelve sessions; day after day

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Patients in G2 will receive Cawthorne Cooksey Exercises in addition to traditional physical therapy program for twelve sessions; day after day .

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Patients in G3 will receive vestibular habituation exercises in addition to traditional physical therapy program for twelve sessions; day after day.

Intervention Type

Other

Intervention Name(s)

Cawthorne Cooksey exercises

Intervention Description

Eye movements and head movements

Intervention Type

Other

Intervention Name(s)

Vestibular habituation exercises

Intervention Description

Move from a sitting position to flat on the back

Intervention Type

Other

Intervention Name(s)

Balance exercises

Intervention Description

Weight Shift Forward and Back

Primary Outcome Measure Information:

Title

Isokinetic dynamometer

Description

Assessment of trunk kinetics

Time Frame

up to 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hosam Magdy Metwally, Doctoral

Organizational Affiliation

October 6 University

Official's Role

Principal Investigator

Facility Information:

Facility Name

October 6 University

City

Giza

ZIP/Postal Code

12511

Country

Egypt

12. IPD Sharing Statement

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Forty Five Patients With Multiple Sclerosis Recieved Vestibular Rehabilitation and Balance Training

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