Vestibular Rehabilitation in MSNCT05635890
Effect of Vestibular Rehabilitation on Trunk Kinetic and Kinematic Parameters in Patients With Multiple Sclerosis
A study testing Cawthorne Cooksey exercise protocol and conventional vestibular rehabilitation in people with Vestibular Rehabilitation in MS, run by October 6 University at 1 site in Egypt.
Trial summary
The Cawthorne Cooksey exercises and conventional program of physical therapy were administered. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Vestibular Rehabilitation in MS
- What is being tested?
- Cawthorne Cooksey exercise protocol and conventional vestibular rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 6 May 2022to 20 Sep 2022
- 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
- Aged 35-55 years.
- Ambulatory without assistance.
- Diagnosed with relapsing-remitting MS by a neurologist, with approximately five relapse attacks in the hemiparesis type with a muscular tone of 1 or 1+ depending on the MAS, or modified Ashworth scale.
- All individuals were evaluated by a neurosurgeon to confirm central vertigo using test of Dix Hallpike.
- Degree of MS-related disability based on the enlarged disability status scale, ranging from 2-2.5.
Who cannot join
- People with musculoskeletal deformities.
- People with inner ear abnormalities.
- People with psychiatric disturbances or seizures.
Trial locations and contacts
1 site in 1 country.
About this study
The Cawthorne Cooksey exercises and conventional program of physical therapy were administered.
Read the detailed description
- The Cawthorne Cooksey exercises and conventional program of physical therapy were administered.
- Conditions
- Vestibular Rehabilitation in MS
- Being tested
- Cawthorne Cooksey exercise protocol, conventional vestibular rehabilitation
- Keywords
- Trunk kinetic and kinematic parameters, Vestibular rehabilitation, Multiple Sclerosis.
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cawthorne Cooksey exercise protocolOther
Cawthorne Cooksey exercise protocol
conventional vestibular rehabilitationOther
conventional vestibular rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | received conventional vestibular rehabilitation along with the Cawthorne Cooksey exercise protocol Receives: Other: Cawthorne Cooksey exercise protocol; Other: conventional vestibular rehabilitation |
| Group II | Active comparator | received conventional vestibular rehabilitation only Receives: Other: conventional vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic dynamometer (average power)
Assess trunk kinetic and kinematic parameters.
Measured: 4 weeks
Isokinetic dynamometer (acceleration time)
Assess trunk kinetic and kinematic parameters.
Measured: 4 weeks
Isokinetic dynamometer (deceleration time)
Assess trunk kinetic and kinematic parameters.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start6 May 2022
- Primary completion10 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular Rehabilitation in MSStudies 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
- Parallel groups
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Magdy Alshimy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635890
- Sponsor's protocol ID
- P.T.REC/012/003988
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vestibular Rehabilitation on Trunk Kinetic and Kinematic Parameters in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05635890
- Acronym / sponsor ID
- P.T.REC/012/003988
- Conditions
- Vestibular Rehabilitation in MS
- Keywords
- Trunk kinetic and kinematic parameters, Vestibular rehabilitation, Multiple Sclerosis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 2 Dec 2022 (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.
The Cawthorne Cooksey exercises and conventional program of physical therapy were administered.
Detailed description
- The Cawthorne Cooksey exercises and conventional program of physical therapy were administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Cawthorne Cooksey exercise protocol, Other: conventional vestibular rehabilitationreceived conventional vestibular rehabilitation along with the Cawthorne Cooksey exercise protocol |
| Group II | Active comparator | Other: conventional vestibular rehabilitationreceived conventional vestibular rehabilitation only |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 35-55 years.
- Ambulatory without assistance.
- Diagnosed with relapsing-remitting MS by a neurologist, with approximately five relapse attacks in the hemiparesis type with a muscular tone of 1 or 1+ depending on the MAS, or modified Ashworth scale.
- All individuals were evaluated by a neurosurgeon to confirm central vertigo using test of Dix Hallpike.
- Degree of MS-related disability based on the enlarged disability status scale, ranging from 2-2.5.
Key exclusion criteria (3 listed)
- People with musculoskeletal deformities.
- People with inner ear abnormalities.
- People with psychiatric disturbances or seizures.
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 exercise protocolCawthorne Cooksey exercise protocol | Other | Group I |
| conventional vestibular rehabilitationconventional vestibular rehabilitation | Other | Group I, Group II |
Primary outcome
Isokinetic dynamometer (average power)
Time frame: 4 weeks
Assess trunk kinetic and kinematic parameters.
Isokinetic dynamometer (acceleration time)
Time frame: 4 weeks
Assess trunk kinetic and kinematic parameters.
Isokinetic dynamometer (deceleration time)
Time frame: 4 weeks
Assess trunk kinetic and kinematic parameters.
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 2 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Vestibular Rehabilitation in MS
Recruiting
Combined Motor Imagery and Vestibular Rehab for MS
Multiple Sclerosis (MS) - Relapsing-remitting
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.
The record lists no contact. Use the official record to reach the sponsor.
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 exercise protocol and conventional vestibular rehabilitation in people with Vestibular Rehabilitation in MS, 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 5 inclusion and 3 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 2 Dec 2022. 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 (average power) (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 2 Dec 2022.