NCT03670459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

September 7, 2018

Last Update Submit

September 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Isokinetic dynamometer

    Assessment of trunk kinetics

    up to 30 days

Study Arms (3)

Group 1

EXPERIMENTAL

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

Other: Balance exercises

Group 2

EXPERIMENTAL

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

Other: Cawthorne Cooksey exercises

Group 3

EXPERIMENTAL

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

Other: Vestibular habituation exercises

Interventions

Eye movements and head movements

Group 2

Move from a sitting position to flat on the back

Group 3

Weight Shift Forward and Back

Group 1

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

Giza, 12511, Egypt

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

  • Hosam Magdy Metwally, Doctoral

    October 6 University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hossam.magdy.pt@o6u.edu.eg

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 13, 2018

Study Start

December 31, 2017

Primary Completion

July 21, 2018

Study Completion

September 4, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations