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Motor Imagery Training in Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Motor imagery training
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dokuz Eylul University Hospital, MS Outpatient Clinic
  • Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Motor imagery training

Control group

Healthy controls

Arm Description

Persons with multiple sclerosis

Persons with multiple sclerosis

Healthy participants

Outcomes

Primary Outcome Measures

Dynamic Gait Index

Secondary Outcome Measures

Expanded Disability Status Scale
Kinesthetic and Visual Imagery Questionnaire (KVIQ)-10
Movement Imagery Questionnaire-Revised Second Edition (MIQ-RS)
Mental Chronometry for 2-Meter Walk Test
Mental Chronometry for 5-Meter Walk Test
Mental Chronometry for 10-Meter Walk Test
Mental Chronometry for Timed 25-Foot Walk
Mental Chronometry for Timed Up and Go Test
Mental Chronometry for Five Times Sit to Stand Test
2-Meter Walk Test
5-Meter Walk Test
10-Meter Walk Test
Timed 25-Foot Walk
2-Minute Walk Test
Twelve Item MS Walking Scale
Timed Up and Go Test
Five Times Sit to Stand Test
Curl-up Test
Activities-specific Balance Confidence Scale
Postural Stability Test by Balance System™
The Limits of Stability Test by Balance System™
Fall Risk Test by Balance System™
Modified Fatigue Impact Scale
Hospital Anxiety and Depression Scale
Multiple Sclerosis International Quality of Life Questionnaire
Symbol Digit Modalities Test
Selective Reminding Test
10/36 Spatial Recall Test

Full Information

First Posted
May 17, 2016
Last Updated
March 30, 2018
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT02781142
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor imagery training
Arm Type
Experimental
Arm Description
Persons with multiple sclerosis
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Persons with multiple sclerosis
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
Healthy participants
Intervention Type
Other
Intervention Name(s)
Motor imagery training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dynamic Gait Index
Time Frame
Change from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Expanded Disability Status Scale
Time Frame
At Baseline
Title
Kinesthetic and Visual Imagery Questionnaire (KVIQ)-10
Time Frame
Change from Baseline at 8 weeks
Title
Movement Imagery Questionnaire-Revised Second Edition (MIQ-RS)
Time Frame
Change from Baseline at 8 weeks
Title
Mental Chronometry for 2-Meter Walk Test
Time Frame
Change from Baseline at 8 weeks
Title
Mental Chronometry for 5-Meter Walk Test
Time Frame
Change from Baseline at 8 weeks
Title
Mental Chronometry for 10-Meter Walk Test
Time Frame
Change from Baseline at 8 weeks
Title
Mental Chronometry for Timed 25-Foot Walk
Time Frame
Change from Baseline at 8 weeks
Title
Mental Chronometry for Timed Up and Go Test
Time Frame
Change from Baseline at 8 weeks
Title
Mental Chronometry for Five Times Sit to Stand Test
Time Frame
Change from Baseline at 8 weeks
Title
2-Meter Walk Test
Time Frame
Change from Baseline at 8 weeks
Title
5-Meter Walk Test
Time Frame
Change from Baseline at 8 weeks
Title
10-Meter Walk Test
Time Frame
Change from Baseline at 8 weeks
Title
Timed 25-Foot Walk
Time Frame
Change from Baseline at 8 weeks
Title
2-Minute Walk Test
Time Frame
Change from Baseline at 8 weeks
Title
Twelve Item MS Walking Scale
Time Frame
Change from Baseline at 8 weeks
Title
Timed Up and Go Test
Time Frame
Change from Baseline at 8 weeks
Title
Five Times Sit to Stand Test
Time Frame
Change from Baseline at 8 weeks
Title
Curl-up Test
Time Frame
Change from Baseline at 8 weeks
Title
Activities-specific Balance Confidence Scale
Time Frame
Change from Baseline at 8 weeks
Title
Postural Stability Test by Balance System™
Time Frame
Change from Baseline at 8 weeks
Title
The Limits of Stability Test by Balance System™
Time Frame
Change from Baseline at 8 weeks
Title
Fall Risk Test by Balance System™
Time Frame
Change from Baseline at 8 weeks
Title
Modified Fatigue Impact Scale
Time Frame
Change from Baseline at 8 weeks
Title
Hospital Anxiety and Depression Scale
Time Frame
Change from Baseline at 8 weeks
Title
Multiple Sclerosis International Quality of Life Questionnaire
Time Frame
Change from Baseline at 8 weeks
Title
Symbol Digit Modalities Test
Time Frame
Change from Baseline at 8 weeks
Title
Selective Reminding Test
Time Frame
Change from Baseline at 8 weeks
Title
10/36 Spatial Recall Test
Time Frame
Change from Baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sema Savci, Prof, PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Turhan Kahraman, MSc
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University Hospital, MS Outpatient Clinic
City
Izmir
ZIP/Postal Code
35430
Country
Turkey
Facility Name
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
City
Izmir
ZIP/Postal Code
35430
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Motor Imagery Training in Persons With Multiple Sclerosis

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