Multiple SclerosisNCT05409599
The Effects of Vestibular Exercise and Cervical Stabilization Exercise Training on Balance and Gait in MS Patients
A study testing Exercises in people with Multiple Sclerosis and Vestibular, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
The population of this research consists of individuals between the ages of 18-65 with MS disease. MS patients to be included in the study will be directed by the Neurology outpatient clinic of Sanko University Hospital. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Vestibular, Exercises
- What is being tested?
- Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Feb 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be diagnosed with MS
- Not having received physiotherapy-oriented treatment in the last 1 year
- not have had an attack in the last 1 month and not be in the attack period
Who cannot join
- having systemic diseases such as hypertension, heart disease, diabetes mellitus, hyperlipidemia, malignancy
- individuals whose ambulation is not independent
- Those who have undergone any surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanko University
Gaziantep, Şehitkamil, 27500
hakan polat, 05386487265, hakan.polat@sanko.edu.tr
About this study
Official title: Comparison of the Effects of Vestibular Exercise and Cervical Stabilization Exercise Training on Balance and Gait in Multiple Sclerosis Patients
The population of this research consists of individuals between the ages of 18-65 with MS disease. MS patients to be included in the study will be directed by the Neurology outpatient clinic of Sanko University Hospital. All volunteers who agreed to participate in this randomized controlled pretest-posttest design study and met the sample criteria will be included in the study.Individuals who agree to participate will be divided into three groups by simple random method and closed envelope method. Vestibular exercise training group will be formed as Group 1 and Cervical stabilization exercise training group as Group 2, control group, and Group 3 as control group.Functional reach test, tandem stand test, 25 step walking test scale form, Multiple Sclerosis Quality of Life Scale form ( MSQOL-54),Fatigue Impact Scale,Beck depression inventory, MS walking scale (msys-12), dizziness disability inventory, four step square test, timed sit and stand test
, 2 minutes walking test be performed before and after treatment,
Read the detailed description
Group 1: Vestibular exercise training will be given in addition to conventional treatment (including TENS, electrical stimulation and normal joint range of motion exercises) for 12 weeks. Cawthorne-Cooksey Exercises will be given as a treatment protocol for vestibular exercise training.
Group 2 :Cervical stabilization exercise training will be given in addition to conventional treatment (including Tens, electrical stimulation and normal range of motion exercises) for 12 weeks. Cervical stabilization training improves the sense of cervical proprioception as well as strength and endurance, thereby reducing joint position sense error. Cervical stabilization exercises and training, consisting of 3 stages with increasing difficulty level, will be applied.
Group3: Classical balance exercise training will be given to the control group in addition to conventional treatment (including Tens, electrical stimulation and normal range of motion exercises) for 12 weeks. These exercises were selected among the exercises routinely used in balance rehabilitation in the literature and clinic.
Balance exercise program: walking on tiptoe and heel, walking straight and diagonally on the line, standing on a balance board, supine/prone rolling on the rehabilitation ball, pelvis control in the sagittal and frontal planes on the rehabilitation ball, prone balance on the rehabilitation ball, walking on mats of different softness , was created from side walking exercises.
- Conditions
- Multiple Sclerosis, Vestibular, Exercises
- Being tested
- Exercises
- Keywords
- Multiple Sclerosis, vestibular exercises, cervical stabilization, gait
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
Exercises
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Exercises | Active comparator | Cawthorne-Cooksey Exercises applied to 1st group for 3 days/week for 12 weeks Receives: Other: Exercises |
| Cervical Stabilization Exercises | Active comparator | cervical stabilization Exercises applied to 1st group for 3 days/week for 12 weeks Receives: Other: Exercises |
| Balance Exercises | Active comparator | classical balance Exercises applied to 1st group for 3 days/week for 12 weeks Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance
functional reach test
Measured: 12 weeks
Gait speed
25-step walking test
Measured: 12 weeks
Dizziness
dizziness disability inventory
Measured: 12 weeks
Dinamic Balance
tandem stance test
Measured: 12 weeks
Dinamic Balance
4 square step test
Measured: 12 weeks
Endurance
2-minute walk test
Measured: 12 weeks
Coordination
timed sit and stand test
Measured: 12 weeks
Postural swing
GYKO
Measured: 12 weeks
Walkiing difficulty
Multiple Sclerosis Walking Scale-12 (MSYS-12)
Measured: 12 Weeks
Secondary outcomes (3)
Fatigue
fatigue impact scale
Measured: 12 weeks
Depression
beck depression inventory
Measured: 12 weeks
MSQ54 İnventory
quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Oct 2021
- Primary completion25 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Polat, Sanko University
- Investigators
- hakan Polat, Study director, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409599
- Sponsor's protocol ID
- HakanP
- Status last verified
- Jan 2023
- First submitted
- 8 Apr 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- 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 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Vestibular Exercise and Cervical Stabilization Exercise Training on Balance and Gait in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05409599
- Acronym / sponsor ID
- HakanP
- Conditions
- Multiple Sclerosis, Vestibular, Exercises
- Keywords
- Multiple Sclerosis, vestibular exercises, cervical stabilization, gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 25 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 8 Jun 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 population of this research consists of individuals between the ages of 18-65 with MS disease. MS patients to be included in the study will be directed by the Neurology outpatient clinic of Sanko University Hospital. All volunteers who agreed to participate in this randomized controlled pretest-posttest design study and met the sample criteria will be included in the study.Individuals who agree to participate will be divided into three groups by simple random method and closed envelope method. Vestibular exercise training group will be formed as Group 1 and Cervical stabilization exercise training group as Group 2, control group, and Group 3 as control group.Functional reach test, tandem stand test, 25 step walking test scale form, Multiple Sclerosis Quality of Life Scale form ( MSQOL-54),Fatigue Impact Scale,Beck depression inventory, MS walking scale (msys-12), dizziness disability inventory, four step square test, timed sit and stand test
, 2 minutes walking test be performed before and after treatment,
Detailed description
Group 1: Vestibular exercise training will be given in addition to conventional treatment (including TENS, electrical stimulation and normal joint range of motion exercises) for 12 weeks. Cawthorne-Cooksey Exercises will be given as a treatment protocol for vestibular exercise training.
Group 2 :Cervical stabilization exercise training will be given in addition to conventional treatment (including Tens, electrical stimulation and normal range of motion exercises) for 12 weeks. Cervical stabilization training improves the sense of cervical proprioception as well as strength and endurance, thereby reducing joint position sense error. Cervical stabilization exercises and training, consisting of 3 stages with increasing difficulty level, will be applied.
Group3: Classical balance exercise training will be given to the control group in addition to conventional treatment (including Tens, electrical stimulation and normal range of motion exercises) for 12 weeks. These exercises were selected among the exercises routinely used in balance rehabilitation in the literature and clinic.
Balance exercise program: walking on tiptoe and heel, walking straight and diagonally on the line, standing on a balance board, supine/prone rolling on the rehabilitation ball, pelvis control in the sagittal and frontal planes on the rehabilitation ball, prone balance on the rehabilitation ball, walking on mats of different softness , was created from side walking exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vestibular Exercises | Active comparator | Other: ExercisesCawthorne-Cooksey Exercises applied to 1st group for 3 days/week for 12 weeks |
| Cervical Stabilization Exercises | Active comparator | Other: Exercisescervical stabilization Exercises applied to 1st group for 3 days/week for 12 weeks |
| Balance Exercises | Active comparator | Other: Exercisesclassical balance Exercises applied to 1st group for 3 days/week for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be diagnosed with MS
- Not having received physiotherapy-oriented treatment in the last 1 year
- not have had an attack in the last 1 month and not be in the attack period
Key exclusion criteria (3 listed)
- having systemic diseases such as hypertension, heart disease, diabetes mellitus, hyperlipidemia, malignancy
- individuals whose ambulation is not independent
- Those who have undergone any surgery in the last 6 months
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 |
|---|---|---|
| ExercisesExercises | Other | Balance Exercises, Cervical Stabilization Exercises, Vestibular Exercises |
Primary outcome
Static Balance
Time frame: 12 weeks
functional reach test
Gait speed
Time frame: 12 weeks
25-step walking test
Dizziness
Time frame: 12 weeks
dizziness disability inventory
Dinamic Balance
Time frame: 12 weeks
tandem stance test
Dinamic Balance
Time frame: 12 weeks
4 square step test
Endurance
Time frame: 12 weeks
2-minute walk test
Coordination
Time frame: 12 weeks
timed sit and stand test
Postural swing
Time frame: 12 weeks
GYKO
Walkiing difficulty
Time frame: 12 Weeks
Multiple Sclerosis Walking Scale-12 (MSYS-12)
3 secondary outcomes
Fatigue
Time frame: 12 weeks
Depression
Time frame: 12 weeks
MSQ54 İnventory
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
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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.
hakan Polat study director
Sanko 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 Exercises in people with Multiple Sclerosis and Vestibular, run by Sanko University at 1 site in Turkey (Türkiye).
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 3 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: status not confirmed, as of the sponsor's last update on 23 Jan 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakan Polat (05386487265, hakan.polat@sanko.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance (time frame: 12 weeks). The study lists 9 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 23 Jan 2023.