NCT02781142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started May 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

May 17, 2016

Last Update Submit

March 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dynamic Gait Index

    Change from Baseline at 8 weeks

Secondary Outcomes (28)

  • Expanded Disability Status Scale

    At Baseline

  • Kinesthetic and Visual Imagery Questionnaire (KVIQ)-10

    Change from Baseline at 8 weeks

  • Movement Imagery Questionnaire-Revised Second Edition (MIQ-RS)

    Change from Baseline at 8 weeks

  • Mental Chronometry for 2-Meter Walk Test

    Change from Baseline at 8 weeks

  • Mental Chronometry for 5-Meter Walk Test

    Change from Baseline at 8 weeks

  • +23 more secondary outcomes

Study Arms (3)

Motor imagery training

EXPERIMENTAL

Persons with multiple sclerosis

Other: Motor imagery training

Control group

NO INTERVENTION

Persons with multiple sclerosis

Healthy controls

NO INTERVENTION

Healthy participants

Interventions

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.

Motor imagery training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having severe musculoskeletal, cardiovascular, pulmonary, or metabolic disease
  • Severe cognitive impairment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dokuz Eylul University Hospital, MS Outpatient Clinic

Izmir, 35430, Turkey (Türkiye)

Location

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Izmir, 35430, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sema Savci, Prof, PhD

    Dokuz Eylul University

    STUDY DIRECTOR
  • Turhan Kahraman, MSc

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 24, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

April 3, 2018

Record last verified: 2018-03

Locations