Investigation of the Effects of Motor Imagery and Action Observation Training in Individuals With Multiple Sclerosis

January 30, 2023 updated by: Melike Sumeyye Ozen, Hacettepe University

Investigation of the Effects of Motor Imagery and Action Observation Training on Walking, Fatigue, Trunk Control and Muscle Oxygenation in Individuals With Multiple Sclerosis

It was planned to examine the effects of motor imagery and action observation training applied in addition to standard rehabilitation in individuals with Multiple Sclerosis on walking, fatigue, trunk control and muscle oxygenation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Hacettepe University
        • Principal Investigator:
          • MELIKE S CENGİZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being between the ages of 18-65
  • Having a definite diagnosis of MS
  • Expanded Disability Status Scale (EDSS) score of 4.0 and below (it is determined routinely by the physician during the examination)
  • Not having an attack in the last 3 months

Exclusion Criteria:

  • Having another musculoskeletal, cardiovascular, pulmonary, metabolic, or neurological disease severe enough to preclude participation in the study.
  • Having severe vision and hearing problems
  • Presence of severe cognitive impairment detected by the physician at a level that prevents the tests from being performed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 Group
Individuals included in this group will receive 20 minutes of motor imagery training in addition to 40 minutes of standard rehabilitation. Patients will be trained 3 days a week for 6 weeks.
Other: Motor Imagery training
Individuals included in this group will receive 20 minutes of motor imagery training in addition to 40 minutes of standard rehabilitation.
Other: standard rehabilitation
40 minutes of standard rehabilitation.
Experimental: Action Observation Group
Individuals included in this group will receive 20 minutes of action observation training in addition to 40 minutes of standard rehabilitation. Patients will be trained 3 days a week for 6 weeks.
Other: standard rehabilitation
40 minutes of standard rehabilitation.
Other: Action Observation training
Individuals included in this group will receive 20 minutes of action observation training in addition to 40 minutes of standard rehabilitation.
Other: Control Group
Individuals included in this group will receive only 40 minutes of standard rehabilitation. Patients will be trained 3 days a week for 6 weeks.
Other: standard rehabilitation
40 minutes of standard rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Min Walking Test
Time Frame: 6 week
It will be used to measure walking capacity. Before the test is applied, necessary information will be given to the individuals and they will be asked to walk as fast as possible for 6 minutes on the 30-meter track.
6 week
Timed Up and Go Test
Time Frame: 6 week
It will be used to assess the functional mobility of individuals. Individuals will be asked to stand up without support from the chair they are sitting in, and to return from the designated area after walking a distance of 3 meters and sit back on the chair without support.
6 week
Dynamic Gait Index
Time Frame: 6 week
It is a scale that evaluates gait balance in MS patients. It examines the balance in completely different walking situations, including daily life activities such as turning the head while walking, taking a step over an obstacle, climbing and descending stairs.
6 week
Multiple Sclerosis Walking Scale-12
Time Frame: 6 week
It is a scale used to measure walking capacity.
6 week
RehaGait® (Hasomed, Magdeburg, Germany) Gait Analysis
Time Frame: 6 week
The device gives about the time-distance characteristics and kinematic data of the gait.
6 week
Fatigue Severity Scale
Time Frame: 6 week
It is a scale that evaluates the extent to which fatigue affects the daily functions of MS patients.
6 week
Trunk Impairment Scale
Time Frame: 6 week
It is used to evaluate trunk control.
6 week
Assessment of the Endurance of Core Muscles
Time Frame: 6 week
The McGill protocol will be applied to assess the endurance of the core muscles. This protocol consists of a combination of 4 tests; modified Biering-Sorenson test, trunk flexor endurance test, right and left lateral bridge (lateral plank) tests.
6 week
Assessment of the Strength of Core Muscles
Time Frame: 6 week
It will be evaluated with "Sit-ups" and Modified "Push-ups" tests.
6 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinesthetic and Visual Imagery Questionnaire
Time Frame: 6 week
It is a tool used to assess individuals' imagery levels.
6 week
Movement Imagery Questionnaire-3
Time Frame: 6 week
It is a tool used to assess individuals' imagery levels.
6 week
Mental Stopwatch
Time Frame: 6 week
Mental stopwatch is a method that enables the objective measurement of motor imagery by examining the time difference between the physical execution of the movement (Movement Execution Time, MET) and the mental visualization of the same movement (Movement Imagery Time, MIT).
6 week
Measurement of Muscle Oxygenation
Time Frame: 6 week
It will be measured over the Quadriceps muscle with the MOXY Monitor Device (saturation, Hb values). The Moxy muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near infrared spectroscopy (NIRS).
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Bandırma Onyedi Eylül University

Investigators

  • Principal Investigator: Melike Sumeyye Ozen, M.Sc., Bandırma Onyedi Eylül University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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