Neurologic DisorderNCT03670459
Forty Five Patients With Multiple Sclerosis Recieved Vestibular Rehabilitation and Balance Training
A study testing Cawthorne Cooksey exercises, Vestibular habituation exercises and Balance exercises in people with Neurologic Disorder, run by October 6 University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Neurologic Disorder
- What is being tested?
- Cawthorne Cooksey exercises, Vestibular habituation exercises and Balance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Dec 2017to 4 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurologic Disorder
- Being tested
- Cawthorne Cooksey exercises, Vestibular habituation exercises, Balance exercises
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cawthorne Cooksey exercisesOther
Eye movements and head movements
Vestibular habituation exercisesOther
Move from a sitting position to flat on the back
Balance exercisesOther
Weight Shift Forward and Back
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients in G1 will receive traditional physical therapy program (balance exercises) for twelve sessions; day after day Receives: 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 . Receives: 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. Receives: Other: Vestibular habituation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic dynamometer
Assessment of trunk kinetics
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start31 Dec 2017
- Primary completion21 Jul 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Magdy Metwally, October 6 University
- Investigators
- Hosam Magdy Metwally, Doctoral, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670459
- Sponsor's protocol ID
- Identifier No. 11
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cawthorne Cooksey Versus Vestibular Habituation Exercises on Trunk Kinetics and Velocity of Gait in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03670459
- Acronym / sponsor ID
- Identifier No. 11
- Conditions
- Neurologic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 21 Jul 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Balance exercisesPatients in G1 will receive traditional physical therapy program (balance exercises) for twelve sessions; day after day |
| Group 2 | Experimental | Other: Cawthorne Cooksey exercisesPatients in G2 will receive Cawthorne Cooksey Exercises in addition to traditional physical therapy program for twelve sessions; day after day . |
| Group 3 | Experimental | Other: Vestibular habituation exercisesPatients in G3 will receive vestibular habituation exercises in addition to traditional physical therapy program for twelve sessions; day after day. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- Patients with musculoskeletal deformity.
- Patients with diabetes mellitus.
- Patients with psychological disturbance or seizures.
- Patients with visual or impairment.
- Patients with inner ear disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cawthorne Cooksey exercisesEye movements and head movements | Other | Group 2 |
| Vestibular habituation exercisesMove from a sitting position to flat on the back | Other | Group 3 |
| Balance exercisesWeight Shift Forward and Back | Other | Group 1 |
Primary outcome
Isokinetic dynamometer
Time frame: up to 30 days
Assessment of trunk kinetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hosam Magdy Metwally, Doctoral principal investigator
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cawthorne Cooksey exercises, Vestibular habituation exercises and Balance exercises in people with Neurologic Disorder, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic dynamometer (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.