- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02781142
Motor Imagery Training in Persons With Multiple Sclerosis
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.
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Izmir, Turkey, 35430
- Dokuz Eylul University Hospital, MS Outpatient Clinic
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Izmir, Turkey, 35430
- Dokuz Eylul University, School of Physical Therapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having severe musculoskeletal, cardiovascular, pulmonary, or metabolic disease
- Severe cognitive impairment
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motor imagery training
Persons with multiple sclerosis
|
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.
|
|
No Intervention: Control group
Persons with multiple sclerosis
|
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No Intervention: Healthy controls
Healthy participants
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Dynamic Gait Index
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Timed 25-Foot Walk
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Curl-up Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Symbol Digit Modalities Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Expanded Disability Status Scale
Time Frame: At Baseline
|
At Baseline
|
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Kinesthetic and Visual Imagery Questionnaire (KVIQ)-10
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
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Movement Imagery Questionnaire-Revised Second Edition (MIQ-RS)
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Mental Chronometry for 2-Meter Walk Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Mental Chronometry for 5-Meter Walk Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Mental Chronometry for 10-Meter Walk Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Mental Chronometry for Timed 25-Foot Walk
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Mental Chronometry for Timed Up and Go Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Mental Chronometry for Five Times Sit to Stand Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
2-Meter Walk Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
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5-Meter Walk Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
10-Meter Walk Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
2-Minute Walk Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Twelve Item MS Walking Scale
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Timed Up and Go Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Five Times Sit to Stand Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Activities-specific Balance Confidence Scale
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
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Postural Stability Test by Balance System™
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
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The Limits of Stability Test by Balance System™
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Fall Risk Test by Balance System™
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
|
Modified Fatigue Impact Scale
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
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Hospital Anxiety and Depression Scale
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
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Multiple Sclerosis International Quality of Life Questionnaire
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
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Selective Reminding Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
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10/36 Spatial Recall Test
Time Frame: Change from Baseline at 8 weeks
|
Change from Baseline at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sema Savci, Prof, PhD, Dokuz Eylul University
- Principal Investigator: Turhan Kahraman, MSc, Dokuz Eylul University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2628-GOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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