Clinical trial NCT02781142: Motor Imagery Training in Persons With Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dynamic Gait Index
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Expanded Disability Status Scale
timeFrame: At Baseline
measure: Kinesthetic and Visual Imagery Questionnaire (KVIQ)-10
timeFrame: Change from Baseline at 8 weeks
measure: Movement Imagery Questionnaire-Revised Second Edition (MIQ-RS)
timeFrame: Change from Baseline at 8 weeks
measure: Mental Chronometry for 2-Meter Walk Test
timeFrame: Change from Baseline at 8 weeks
measure: Mental Chronometry for 5-Meter Walk Test
timeFrame: Change from Baseline at 8 weeks
measure: Mental Chronometry for 10-Meter Walk Test
timeFrame: Change from Baseline at 8 weeks
measure: Mental Chronometry for Timed 25-Foot Walk
timeFrame: Change from Baseline at 8 weeks
measure: Mental Chronometry for Timed Up and Go Test
timeFrame: Change from Baseline at 8 weeks
measure: Mental Chronometry for Five Times Sit to Stand Test
timeFrame: Change from Baseline at 8 weeks
measure: 2-Meter Walk Test
timeFrame: Change from Baseline at 8 weeks
measure: 5-Meter Walk Test
timeFrame: Change from Baseline at 8 weeks
measure: 10-Meter Walk Test
timeFrame: Change from Baseline at 8 weeks
measure: Timed 25-Foot Walk
timeFrame: Change from Baseline at 8 weeks
measure: 2-Minute Walk Test
timeFrame: Change from Baseline at 8 weeks
measure: Twelve Item MS Walking Scale
timeFrame: Change from Baseline at 8 weeks
measure: Timed Up and Go Test
timeFrame: Change from Baseline at 8 weeks
measure: Five Times Sit to Stand Test
timeFrame: Change from Baseline at 8 weeks
measure: Curl-up Test
timeFrame: Change from Baseline at 8 weeks
measure: Activities-specific Balance Confidence Scale
timeFrame: Change from Baseline at 8 weeks
measure: Postural Stability Test by Balance System™
timeFrame: Change from Baseline at 8 weeks
measure: The Limits of Stability Test by Balance System™
timeFrame: Change from Baseline at 8 weeks
measure: Fall Risk Test by Balance System™
timeFrame: Change from Baseline at 8 weeks
measure: Modified Fatigue Impact Scale
timeFrame: Change from Baseline at 8 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: Change from Baseline at 8 weeks
measure: Multiple Sclerosis International Quality of Life Questionnaire
timeFrame: Change from Baseline at 8 weeks
measure: Symbol Digit Modalities Test
timeFrame: Change from Baseline at 8 weeks
measure: Selective Reminding Test
timeFrame: Change from Baseline at 8 weeks
measure: 10/36 Spatial Recall Test
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Hospital, MS Outpatient Clinic
city: Izmir
country: Turkey
facility: Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Study officials:
affiliation: Dokuz Eylul University
name: Sema Savci, Prof, PhD
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: Turhan Kahraman, MSc
role: PRINCIPAL_INVESTIGATOR
References: