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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02781142
Other study ID # 2628-GOA
Secondary ID
Status Completed
Phase N/A
First received May 17, 2016
Last updated March 30, 2018
Start date May 2016
Est. completion date November 2017

Study information

Verified date March 2018
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date November 2017
Est. primary completion date October 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Motor imagery training
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.

Locations

Country Name City State
Turkey Dokuz Eylul University Hospital, MS Outpatient Clinic Izmir
Turkey Dokuz Eylul University, School of Physical Therapy and Rehabilitation Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dynamic Gait Index Change from Baseline at 8 weeks
Secondary Expanded Disability Status Scale At Baseline
Secondary Kinesthetic and Visual Imagery Questionnaire (KVIQ)-10 Change from Baseline at 8 weeks
Secondary Movement Imagery Questionnaire—Revised Second Edition (MIQ-RS) Change from Baseline at 8 weeks
Secondary Mental Chronometry for 2-Meter Walk Test Change from Baseline at 8 weeks
Secondary Mental Chronometry for 5-Meter Walk Test Change from Baseline at 8 weeks
Secondary Mental Chronometry for 10-Meter Walk Test Change from Baseline at 8 weeks
Secondary Mental Chronometry for Timed 25-Foot Walk Change from Baseline at 8 weeks
Secondary Mental Chronometry for Timed Up and Go Test Change from Baseline at 8 weeks
Secondary Mental Chronometry for Five Times Sit to Stand Test Change from Baseline at 8 weeks
Secondary 2-Meter Walk Test Change from Baseline at 8 weeks
Secondary 5-Meter Walk Test Change from Baseline at 8 weeks
Secondary 10-Meter Walk Test Change from Baseline at 8 weeks
Secondary Timed 25-Foot Walk Change from Baseline at 8 weeks
Secondary 2-Minute Walk Test Change from Baseline at 8 weeks
Secondary Twelve Item MS Walking Scale Change from Baseline at 8 weeks
Secondary Timed Up and Go Test Change from Baseline at 8 weeks
Secondary Five Times Sit to Stand Test Change from Baseline at 8 weeks
Secondary Curl-up Test Change from Baseline at 8 weeks
Secondary Activities-specific Balance Confidence Scale Change from Baseline at 8 weeks
Secondary Postural Stability Test by Balance System™ Change from Baseline at 8 weeks
Secondary The Limits of Stability Test by Balance System™ Change from Baseline at 8 weeks
Secondary Fall Risk Test by Balance System™ Change from Baseline at 8 weeks
Secondary Modified Fatigue Impact Scale Change from Baseline at 8 weeks
Secondary Hospital Anxiety and Depression Scale Change from Baseline at 8 weeks
Secondary Multiple Sclerosis International Quality of Life Questionnaire Change from Baseline at 8 weeks
Secondary Symbol Digit Modalities Test Change from Baseline at 8 weeks
Secondary Selective Reminding Test Change from Baseline at 8 weeks
Secondary 10/36 Spatial Recall Test Change from Baseline at 8 weeks
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