Multiple SclerosisNCT02781142
Motor Imagery Training in Persons With Multiple Sclerosis
A study testing Motor imagery training in people with Multiple Sclerosis, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).
Trial summary
Motor imagery training facilitates the neural plasticity with increasing the neuronal cortical pathways in the brain. Motor imagery training is an effective way in stroke survivors. However, its effects in persons with multiple sclerosis (MS) are not known. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Motor imagery training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- May 2016to Nov 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of multiple sclerosis
- Having the Expanded Disability Status Scale 0 - 4.0
- Relapse-free period at the last 3 months
- Enough computer use ability
- Having computer and internet connection
Who cannot join
- Having severe musculoskeletal, cardiovascular, pulmonary, or metabolic disease
- Severe cognitive impairment
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Dokuz Eylul University Hospital, MS Outpatient Clinic
Izmir, 35430
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Izmir, 35430
About this study
Official title: The Effect of Telerehabilitation Based Motor Imagery Training on Gait and Balance Performance of the Persons With Multiple Sclerosis: A Randomized Controlled Trial
Motor imagery training facilitates the neural plasticity with increasing the neuronal cortical pathways in the brain. Motor imagery training is an effective way in stroke survivors. However, its effects in persons with multiple sclerosis (MS) are not known. Additionally, telerehabilitation based motor imagery training is very rare treatment way which requires more research. Therefore, this study aims to investigate the effect of telerehabilitation based motor imagery training on gait and balance performance of the persons with MS.
The participants will be allocated into three groups, including motor imagery training, wait-list control group, and healthy control group.
Read more
All the assessments will be performed before and after the training in the 8-week motor imagery training group. The participants in the control group will underwent the assessment with a 8-week interval. The healthy participants will be assessed only one.
The motor imagery training will be designed for the individual basis with following standard protocols. It will be applied two times a week for 8 weeks. The first one and/or two sessions will be performed in the clinic, the other will be performed at the patients' home with a video-conference telerehabilitation technique.
Read the detailed description
Multiple sclerosis (MS) is a chronic, inflammatory, and demyelinating disease of the central nervous system. It is the most common neurological disease which causes progressive gait and balance disorders in young adults. The previous studies have indicated that home care and treatment services, which accelerates the healing process and makes the one feel better, are more preferred by the patients. Persons with MS are commonly not able to access the institutional rehabilitation services because of their disability and/or home location. It restricts the participation of the persons with MS and their treatment benefits. In recent years, the telerehabilitation programs are increasing to overcome this problem. Motor imagery training also stands as a good option in the rehabilitation programs. Motor imagery is a mental process by which an individual rehearses or simulates a given action. Motor imagery training facilitates the neural plasticity with increasing the neuronal cortical pathways in the brain. Motor imagery training is an effective way in stroke survivors. However, its effects in persons with MS are not known. Additionally, telerehabilitation based motor imagery training is very rare treatment way which requires more research.
The aim of this study is to investigate the effect of telerehabilitation based motor imagery training on gait and balance performance of the persons with MS.
The participants will be allocated into three groups, including motor imagery training group, control group, and healthy control group. The persons with MS will be recruited from the outpatient MS clinic of Dokuz Eylul University, and the healthy participants will be recruited from the stuff of Dokuz Eylul University.
The inclusion and exclusion criteria assessments and the neurological examination will be performed by a blinded neurologist specialized in MS. The cognition, fatigue, depression, and quality of life assessment will be performed by a blinded neuropsychologist. The remaining assessments, including walking, balance, and motor imagery abilities will be assessed by a blinded physiotherapist. All the assessments will be performed before and after the training in the 8-week motor imagery training group. The participants in the control group will underwent the assessment with a 8-week interval. The healthy participants will be assessed only one.
The motor imagery training will be designed for the individual basis with following standard protocols. It will be applied two times a week for 8 weeks. The first one and/or two sessions will be performed in the clinic, the other will be performed at the patients' home with a video-conference telerehabilitation technique.
- Conditions
- Multiple Sclerosis
- Being tested
- Motor imagery training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imagery trainingOther
The motor imagery training will be designed for the individual basis with following standard protocols. It will be applied two times a week for 8 weeks. The first one and/or two sessions will be performed in the clinic, the other will be performed at the patients' home with a video-conference telerehabilitation technique.
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery training | Experimental | Persons with multiple sclerosis Receives: Other: Motor imagery training |
| Control group | No intervention | Persons with multiple sclerosis |
| Healthy controls | No intervention | Healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index
Measured: Change from Baseline at 8 weeks
Secondary outcomes (28)
Expanded Disability Status Scale
Measured: At Baseline
Kinesthetic and Visual Imagery Questionnaire (KVIQ)-10
Measured: Change from Baseline at 8 weeks
Movement Imagery Questionnaire-Revised Second Edition (MIQ-RS)
Measured: Change from Baseline at 8 weeks
Mental Chronometry for 2-Meter Walk Test
Measured: Change from Baseline at 8 weeks
Mental Chronometry for 5-Meter Walk Test
Measured: Change from Baseline at 8 weeks
Mental Chronometry for 10-Meter Walk Test
Measured: Change from Baseline at 8 weeks
Mental Chronometry for Timed 25-Foot Walk
Measured: Change from Baseline at 8 weeks
Mental Chronometry for Timed Up and Go Test
Measured: Change from Baseline at 8 weeks
Mental Chronometry for Five Times Sit to Stand Test
Measured: Change from Baseline at 8 weeks
2-Meter Walk Test
Measured: Change from Baseline at 8 weeks
5-Meter Walk Test
Measured: Change from Baseline at 8 weeks
10-Meter Walk Test
Measured: Change from Baseline at 8 weeks
Timed 25-Foot Walk
Measured: Change from Baseline at 8 weeks
2-Minute Walk Test
Measured: Change from Baseline at 8 weeks
Twelve Item MS Walking Scale
Measured: Change from Baseline at 8 weeks
Timed Up and Go Test
Measured: Change from Baseline at 8 weeks
Five Times Sit to Stand Test
Measured: Change from Baseline at 8 weeks
Curl-up Test
Measured: Change from Baseline at 8 weeks
Activities-specific Balance Confidence Scale
Measured: Change from Baseline at 8 weeks
Postural Stability Test by Balance System™
Measured: Change from Baseline at 8 weeks
The Limits of Stability Test by Balance System™
Measured: Change from Baseline at 8 weeks
Fall Risk Test by Balance System™
Measured: Change from Baseline at 8 weeks
Modified Fatigue Impact Scale
Measured: Change from Baseline at 8 weeks
Hospital Anxiety and Depression Scale
Measured: Change from Baseline at 8 weeks
Multiple Sclerosis International Quality of Life Questionnaire
Measured: Change from Baseline at 8 weeks
Symbol Digit Modalities Test
Measured: Change from Baseline at 8 weeks
Selective Reminding Test
Measured: Change from Baseline at 8 weeks
10/36 Spatial Recall Test
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017
- Study completionNov 2017
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
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turhan Kahraman, Dokuz Eylul University
- Investigators
- Sema Savci, Prof, PhD, Study director, Dokuz Eylul UniversityTurhan Kahraman, MSc, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781142
- Sponsor's protocol ID
- 2628-GOA
- Status last verified
- Mar 2018
- First submitted
- 17 May 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telerehabilitation Based Motor Imagery Training on Gait and Balance Performance of the Persons With Multiple Sclerosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02781142
- Acronym / sponsor ID
- 2628-GOA
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 24 May 2016 (estimated)
- 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.
Motor imagery training facilitates the neural plasticity with increasing the neuronal cortical pathways in the brain. Motor imagery training is an effective way in stroke survivors. However, its effects in persons with multiple sclerosis (MS) are not known. Additionally, telerehabilitation based motor imagery training is very rare treatment way which requires more research. Therefore, this study aims to investigate the effect of telerehabilitation based motor imagery training on gait and balance performance of the persons with MS.
The participants will be allocated into three groups, including motor imagery training, wait-list control group, and healthy control group.
All the assessments will be performed before and after the training in the 8-week motor imagery training group. The participants in the control group will underwent the assessment with a 8-week interval. The healthy participants will be assessed only one.
The motor imagery training will be designed for the individual basis with following standard protocols. It will be applied two times a week for 8 weeks. The first one and/or two sessions will be performed in the clinic, the other will be performed at the patients' home with a video-conference telerehabilitation technique.
Detailed description
Multiple sclerosis (MS) is a chronic, inflammatory, and demyelinating disease of the central nervous system. It is the most common neurological disease which causes progressive gait and balance disorders in young adults. The previous studies have indicated that home care and treatment services, which accelerates the healing process and makes the one feel better, are more preferred by the patients. Persons with MS are commonly not able to access the institutional rehabilitation services because of their disability and/or home location. It restricts the participation of the persons with MS and their treatment benefits. In recent years, the telerehabilitation programs are increasing to overcome this problem. Motor imagery training also stands as a good option in the rehabilitation programs. Motor imagery is a mental process by which an individual rehearses or simulates a given action. Motor imagery training facilitates the neural plasticity with increasing the neuronal cortical pathways in the brain. Motor imagery training is an effective way in stroke survivors. However, its effects in persons with MS are not known. Additionally, telerehabilitation based motor imagery training is very rare treatment way which requires more research.
The aim of this study is to investigate the effect of telerehabilitation based motor imagery training on gait and balance performance of the persons with MS.
The participants will be allocated into three groups, including motor imagery training group, control group, and healthy control group. The persons with MS will be recruited from the outpatient MS clinic of Dokuz Eylul University, and the healthy participants will be recruited from the stuff of Dokuz Eylul University.
The inclusion and exclusion criteria assessments and the neurological examination will be performed by a blinded neurologist specialized in MS. The cognition, fatigue, depression, and quality of life assessment will be performed by a blinded neuropsychologist. The remaining assessments, including walking, balance, and motor imagery abilities will be assessed by a blinded physiotherapist. All the assessments will be performed before and after the training in the 8-week motor imagery training group. The participants in the control group will underwent the assessment with a 8-week interval. The healthy participants will be assessed only one.
The motor imagery training will be designed for the individual basis with following standard protocols. It will be applied two times a week for 8 weeks. The first one and/or two sessions will be performed in the clinic, the other will be performed at the patients' home with a video-conference telerehabilitation technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motor imagery training | Experimental | Other: Motor imagery trainingPersons with multiple sclerosis |
| Control group | No intervention | –Persons with multiple sclerosis |
| Healthy controls | No intervention | –Healthy participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of multiple sclerosis
- Having the Expanded Disability Status Scale 0 - 4.0
- Relapse-free period at the last 3 months
- Enough computer use ability
- Having computer and internet connection
Key exclusion criteria (3 listed)
- Having severe musculoskeletal, cardiovascular, pulmonary, or metabolic disease
- Severe cognitive impairment
- Pregnancy
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 |
|---|---|---|
| Motor imagery trainingThe motor imagery training will be designed for the individual basis with following standard protocols. It will be applied two times a week for 8 weeks. The first one and/or two sessions will be performed in the clinic, the other will be performed at the patients' home with a video-conference telerehabilitation technique. | Other | Motor imagery training |
Primary outcome
Dynamic Gait Index
Time frame: Change from Baseline at 8 weeks
28 secondary outcomes
Expanded Disability Status Scale
Time frame: At Baseline
Kinesthetic and Visual Imagery Questionnaire (KVIQ)-10
Time frame: Change from Baseline at 8 weeks
Movement Imagery Questionnaire-Revised Second Edition (MIQ-RS)
Time frame: Change from Baseline at 8 weeks
Mental Chronometry for 2-Meter Walk Test
Time frame: Change from Baseline at 8 weeks
Mental Chronometry for 5-Meter Walk Test
Time frame: Change from Baseline at 8 weeks
Mental Chronometry for 10-Meter Walk Test
Time frame: Change from Baseline at 8 weeks
Mental Chronometry for Timed 25-Foot Walk
Time frame: Change from Baseline at 8 weeks
Mental Chronometry for Timed Up and Go Test
Time frame: Change from Baseline at 8 weeks
Mental Chronometry for Five Times Sit to Stand Test
Time frame: Change from Baseline at 8 weeks
2-Meter Walk Test
Time frame: Change from Baseline at 8 weeks
5-Meter Walk Test
Time frame: Change from Baseline at 8 weeks
10-Meter Walk Test
Time frame: Change from Baseline at 8 weeks
Timed 25-Foot Walk
Time frame: Change from Baseline at 8 weeks
2-Minute Walk Test
Time frame: Change from Baseline at 8 weeks
Twelve Item MS Walking Scale
Time frame: Change from Baseline at 8 weeks
Timed Up and Go Test
Time frame: Change from Baseline at 8 weeks
Five Times Sit to Stand Test
Time frame: Change from Baseline at 8 weeks
Curl-up Test
Time frame: Change from Baseline at 8 weeks
Activities-specific Balance Confidence Scale
Time frame: Change from Baseline at 8 weeks
Postural Stability Test by Balance System™
Time frame: Change from Baseline at 8 weeks
The Limits of Stability Test by Balance System™
Time frame: Change from Baseline at 8 weeks
Fall Risk Test by Balance System™
Time frame: Change from Baseline at 8 weeks
Modified Fatigue Impact Scale
Time frame: Change from Baseline at 8 weeks
Hospital Anxiety and Depression Scale
Time frame: Change from Baseline at 8 weeks
Multiple Sclerosis International Quality of Life Questionnaire
Time frame: Change from Baseline at 8 weeks
Symbol Digit Modalities Test
Time frame: Change from Baseline at 8 weeks
Selective Reminding Test
Time frame: Change from Baseline at 8 weeks
10/36 Spatial Recall Test
Time frame: Change from Baseline at 8 weeks
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 3 Apr 2018.
- 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.
Sema Savci, Prof, PhD study director
Dokuz Eylul University
Turhan Kahraman, MSc principal investigator
Dokuz Eylul University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery training in people with Multiple Sclerosis, run by Dokuz Eylul University at 2 sites 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 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 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Dynamic Gait Index (time frame: Change from Baseline at 8 weeks). 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 3 Apr 2018.