Multiple SclerosisNCT05299151
Gait Analysis in Multiple Sclerosis Patients
A study testing Vestibular exercises and Standard neurorehabilitation exercises in people with Multiple Sclerosis and 3D Gait Analysis, run by Istanbul Kültür University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, the results of vestibular rehabilitation treatment applied in patients with Multiple Sclerosis (MS) have been investigated in detail under the headings such as fatigue, physical activity level, and quality of life, and its effects on walking have also been tried to be examined. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, 3D Gait Analysis, Vestibular Rehabilitation
- What is being tested?
- Vestibular exercises and Standard neurorehabilitation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 May 2024
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between aged 25-60 years
- Diagnosed with MS for at least 5 years
- Relapsing and progressive MS according to Mc Donald criteria
- EDSS score of ≤ 3.5 ≤ 6
- Modified Ashworth Scale < 3
- Being eligible to work by a neurologist
Who cannot join
- Having had an MS-related attack in the 3 months before the study
- Changes in medications within 6 months prior to the study
- To have participated in the rehabilitation program within 1 month before the study
- Serious neurological, cardiac, pulmonary, rheumatological, audiovisual, or orthopedic disorders that limit assessments and/or intervention programs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpaşa, Vocational School of Health Services
Istanbul
About this study
Official title: The Effect of Vestibular Rehabilitation on the Kinetic and Kinematic Parameters of Walking in Patients With Multiple Sclerosis
In the literature, the results of vestibular rehabilitation treatment applied in patients with Multiple Sclerosis (MS) have been investigated in detail under the headings such as fatigue, physical activity level, and quality of life, and its effects on walking have also been tried to be examined. However, in the studies conducted, gait assessments were made through questionnaires and timed tests, and devices that provide more objective data such as 3-dimensional gait analysis were not used. Again, the effects of vestibular rehabilitation programs on dual-task were not examined in previous studies.
Therefore, the aims of our study are:
- To determine the effect of individually designed vestibular rehabilitation exercises on the kinetic and kinematic components of walking;
- To determine the effect of vestibular rehabilitation exercises specially designed for the person on gait parameters during cognitive and motor tasks.
- Being tested
- Vestibular exercises, Standard neurorehabilitation exercises
- Keywords
- gait analysis, multiple sclerosis, vestibular, kinetic, kinematic
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular exercisesOther
The vestibular exercise program basically consists of 3 groups of exercises: adaptation, substitution, and habituation exercises. It is aimed to provide vestibular adaptation with adaptation exercises. Exercises that include visual and somatosensory cues to improve gaze and postural stability constitute substitution exercises. Balance exercises can be performed with eyes open and closed, or somatosensory cues can be changed by performing them on soft ground. Removing or reducing clues allows the patient to use other systems as well. The basis of habituation exercises is the reduction of the pathological response as a result of repeated exposure to the provocative stimulus. Habituation is specific to the type, intensity, and direction of stimuli. In most cases, the movement that stimulates the pathological response is less frequently performed during daily activities and promotes compensation for the initially abnormal signal of treatment.
Standard neurorehabilitation exercisesOther
A neurorehabilitation program based on stretching, strengthening, posture, mobilization, static and dynamic balance exercises (standing on one leg, tandem, balance board, etc.) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation Group | Experimental | A vestibular rehabilitation exercise program, which is determined based on the literature and personalized according to the functional disabilities of each patient, will be applied to the participants in the experimental group. An exercise session will be performed for a total of 40 minutes, with each exercise for 1-2 minutes. Exercise training will be applied 2 days a week for 8 weeks and they will be asked to do it at home once a week. Receives: Other: Vestibular exercises |
| Standard Neurorehabilitation Group | Active comparator | A neurorehabilitation program based on stretching, strengthening, posture, mobilization, static and dynamic balance exercises will be applied. Each training session will be 40 minutes in total. Exercise training will be done in the clinical setting 2 days a week for 8 weeks, and they will be asked to do it at home once a week. Receives: Other: Standard neurorehabilitation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D Gait Analysis System - pre assesment
Kinetic and kinematic data of gait will be collected in the motion analysis laboratory using 6 infrared digital cameras (Vantage 5.0), 2 synchronized video cameras (Vicon Vue) and 2 force platforms (AMTI).
Measured: It will be done at the beginning of the study. An analysis session lasts nearly 2 hours per patient. Evaluation of all participants will take approximately 2 months.
3D Gait Analysis System - post assesment
Kinetic and kinematic data of gait will be collected in the motion analysis laboratory using
Measured: It will be done at the end of the study. An analysis session lasting nearly 2 hours per patient. Evaluation of all participants will take approximately 2 months.
Secondary outcomes (6)
One Leg Standing Test - pre assesment
It will be used to determine the patient's standing balance. The duration of standing on one leg will be recorded with a stopwatch and 3 repetitions will be taken and the most successful score will be used in the analysis.
Measured: It will be done at the beginning of the study. The test lasts nearly 5 minutes.
One Leg Standing Test - post assessment
It will be used to determine the patient's standing balance. The duration of standing on one leg will be recorded with a stopwatch and 3 repetitions will be taken and the most successful score will be used in the analysis.
Measured: It will be done at the end of the study. The test lasts nearly 5 minutes.
Dizziness Handicap Inventory - pre assessment
The Dizziness Disability Inventory consists of 25 items that determine the aggravating factors of patients' dizziness and balance disorder, as well as emotional and functional outcomes in vestibular system diseases. It includes 9 items that determine emotional and functional status, and seven items that determine physical function.
Measured: It will be done at the beginning of the study. The test lasts nearly 15 minutes.
Dizziness Handicap Inventory - post assessment
The Dizziness Disability Inventory consists of 25 items that determine the aggravating factors of patients' dizziness and balance disorder, as well as emotional and functional outcomes in vestibular system diseases. It includes 9 items that determine emotional and functional status, and seven items that determine physical function.
Measured: It will be done at the end of the study. The test lasts nearly 15 minutes.
2 Minute Walking Test - pre assessment
The distance that patients will walk for 2 minutes will be measured and recorded.
Measured: It will be done at the beginning of the study. The test lasts nearly 5 minutes.
2 Minute Walking Test - post assessment
The distance that patients will walk for 2 minutes will be measured and recorded.
Measured: It will be done at the end of the study. The test lasts nearly 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Jun 2022
- Primary completion1 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kültür University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Gamze Ertürk, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299151
- Sponsor's protocol ID
- VR-1
- Status last verified
- Jul 2024
- First submitted
- 9 Mar 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Comber L, Galvin R, Coote S. Gait deficits in people with multiple sclerosis: A systematic review and meta-analysis. Gait Posture. 2017 Jan;51:25-35. doi: 10.1016/j.gaitpost.2016.09.026. Epub 2016 Sep 26.
PubMed 27693958Huisinga JM, Schmid KK, Filipi ML, Stergiou N. Gait mechanics are different between healthy controls and patients with multiple sclerosis. J Appl Biomech. 2013 Jun;29(3):303-11. doi: 10.1123/jab.29.3.303. Epub 2012 Aug 22.
PubMed 22923390Garcia-Munoz C, Cortes-Vega MD, Heredia-Rizo AM, Martin-Valero R, Garcia-Bernal MI, Casuso-Holgado MJ. Effectiveness of Vestibular Training for Balance and Dizziness Rehabilitation in People with Multiple Sclerosis: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Feb 21;9(2):590. doi: 10.3390/jcm9020590.
PubMed 32098162Gunn H, Markevics S, Haas B, Marsden J, Freeman J. Systematic Review: The Effectiveness of Interventions to Reduce Falls and Improve Balance in Adults With Multiple Sclerosis. Arch Phys Med Rehabil. 2015 Oct;96(10):1898-912. doi: 10.1016/j.apmr.2015.05.018. Epub 2015 Jun 10.
PubMed 26070975
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular Rehabilitation on the Kinetic and Kinematic Parameters of Walking in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05299151
- Acronym / sponsor ID
- VR-1
- Keywords
- gait analysis, multiple sclerosis, vestibular, kinetic, kinematic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Istanbul Kültür UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 28 Mar 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.
In the literature, the results of vestibular rehabilitation treatment applied in patients with Multiple Sclerosis (MS) have been investigated in detail under the headings such as fatigue, physical activity level, and quality of life, and its effects on walking have also been tried to be examined. However, in the studies conducted, gait assessments were made through questionnaires and timed tests, and devices that provide more objective data such as 3-dimensional gait analysis were not used. Again, the effects of vestibular rehabilitation programs on dual-task were not examined in previous studies.
Therefore, the aims of our study are:
- To determine the effect of individually designed vestibular rehabilitation exercises on the kinetic and kinematic components of walking;
- To determine the effect of vestibular rehabilitation exercises specially designed for the person on gait parameters during cognitive and motor tasks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation Group | Experimental | Other: Vestibular exercisesA vestibular rehabilitation exercise program, which is determined based on the literature and personalized according to the functional disabilities of each patient, will be applied to the participants in the experimental group. An exercise session will be performed for a total of 40 minutes, with each exercise for 1-2 minutes. Exercise training will be applied 2 days a week for 8 weeks and they will be asked to do it at home once a week. |
| Standard Neurorehabilitation Group | Active comparator | Other: Standard neurorehabilitation exercisesA neurorehabilitation program based on stretching, strengthening, posture, mobilization, static and dynamic balance exercises will be applied. Each training session will be 40 minutes in total. Exercise training will be done in the clinical setting 2 days a week for 8 weeks, and they will be asked to do it at home once a week. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between aged 25-60 years
- Diagnosed with MS for at least 5 years
- Relapsing and progressive MS according to Mc Donald criteria
- EDSS score of ≤ 3.5 ≤ 6
- Modified Ashworth Scale < 3
Key exclusion criteria (4 listed)
- Having had an MS-related attack in the 3 months before the study
- Changes in medications within 6 months prior to the study
- To have participated in the rehabilitation program within 1 month before the study
- Serious neurological, cardiac, pulmonary, rheumatological, audiovisual, or orthopedic disorders that limit assessments and/or intervention programs
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 |
|---|---|---|
| Vestibular exercisesThe vestibular exercise program basically consists of 3 groups of exercises: adaptation, substitution, and habituation exercises. It is aimed to provide vestibular adaptation with adaptation exercises. Exercises that include visual and somatosensory cues to improve gaze and postural stability constitute substitution exercises. Balance exercises can be performed with eyes open and closed, or somatosensory cues can be changed by performing them on soft ground. Removing or reducing clues allows the patient to use other systems as well. The basis of habituation exercises is the reduction of the pathological response as a result of repeated exposure to the provocative stimulus. Habituation is specific to the type, intensity, and direction of stimuli. In most cases, the movement that stimulates the pathological response is less frequently performed during daily activities and promotes compensation for the initially abnormal signal of treatment. | Other | Vestibular Rehabilitation Group |
| Standard neurorehabilitation exercisesA neurorehabilitation program based on stretching, strengthening, posture, mobilization, static and dynamic balance exercises (standing on one leg, tandem, balance board, etc.) will be applied. | Other | Standard Neurorehabilitation Group |
Primary outcome
3D Gait Analysis System - pre assesment
Time frame: It will be done at the beginning of the study. An analysis session lasts nearly 2 hours per patient. Evaluation of all participants will take approximately 2 months.
Kinetic and kinematic data of gait will be collected in the motion analysis laboratory using 6 infrared digital cameras (Vantage 5.0), 2 synchronized video cameras (Vicon Vue) and 2 force platforms (AMTI).
3D Gait Analysis System - post assesment
Time frame: It will be done at the end of the study. An analysis session lasting nearly 2 hours per patient. Evaluation of all participants will take approximately 2 months.
Kinetic and kinematic data of gait will be collected in the motion analysis laboratory using
6 secondary outcomes
One Leg Standing Test - pre assesment
Time frame: It will be done at the beginning of the study. The test lasts nearly 5 minutes.
One Leg Standing Test - post assessment
Time frame: It will be done at the end of the study. The test lasts nearly 5 minutes.
Dizziness Handicap Inventory - pre assessment
Time frame: It will be done at the beginning of the study. The test lasts nearly 15 minutes.
Dizziness Handicap Inventory - post assessment
Time frame: It will be done at the end of the study. The test lasts nearly 15 minutes.
2 Minute Walking Test - pre assessment
Time frame: It will be done at the beginning of the study. The test lasts nearly 5 minutes.
2 Minute Walking Test - post assessment
Time frame: It will be done at the end of the study. The test lasts nearly 5 minutes.
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 9 Jul 2024.
- Background: PubMed 27693958Comber L, Galvin R, Coote S. Gait deficits in people with multiple sclerosis: A systematic review and meta-analysis. Gait Posture. 2017 Jan;51:25-35. doi: 10.1016/j.gaitpost.2016.09.026. Epub 2016 Sep 26.
- Background: PubMed 22923390Huisinga JM, Schmid KK, Filipi ML, Stergiou N. Gait mechanics are different between healthy controls and patients with multiple sclerosis. J Appl Biomech. 2013 Jun;29(3):303-11. doi: 10.1123/jab.29.3.303. Epub 2012 Aug 22.
- Background: PubMed 32098162Garcia-Munoz C, Cortes-Vega MD, Heredia-Rizo AM, Martin-Valero R, Garcia-Bernal MI, Casuso-Holgado MJ. Effectiveness of Vestibular Training for Balance and Dizziness Rehabilitation in People with Multiple Sclerosis: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Feb 21;9(2):590. doi: 10.3390/jcm9020590.
- Background: PubMed 26070975Gunn H, Markevics S, Haas B, Marsden J, Freeman J. Systematic Review: The Effectiveness of Interventions to Reduce Falls and Improve Balance in Adults With Multiple Sclerosis. Arch Phys Med Rehabil. 2015 Oct;96(10):1898-912. doi: 10.1016/j.apmr.2015.05.018. Epub 2015 Jun 10.
- Individual participant dataSharing planned: Undecided
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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.
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 Vestibular exercises and Standard neurorehabilitation exercises in people with Multiple Sclerosis and 3D Gait Analysis, run by Istanbul Kültür 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 6 inclusion and 4 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 9 Jul 2024. 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?
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?
3D Gait Analysis System - pre assesment (time frame: It will be done at the beginning of the study. An analysis session lasts nearly 2 hours per patient. Evaluation of all participants will take approximately 2 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299151, which also lists 4 linked publications.
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 9 Jul 2024.