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

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Motor Imagery training
Action Observation training
standard rehabilitation
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Motor Imagery Training, Action Observation Training, Walking, Fatigue, Trunk Control, Muscle Oxygenation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Motor Imagery Group

Action Observation Group

Control Group

Arm Description

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.

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.

Individuals included in this group will receive only 40 minutes of standard rehabilitation. Patients will be trained 3 days a week for 6 weeks.

Outcomes

Primary Outcome Measures

6 Min Walking Test
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.
Timed Up and Go Test
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.
Dynamic Gait Index
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.
Multiple Sclerosis Walking Scale-12
It is a scale used to measure walking capacity.
RehaGait® (Hasomed, Magdeburg, Germany) Gait Analysis
The device gives about the time-distance characteristics and kinematic data of the gait.
Fatigue Severity Scale
It is a scale that evaluates the extent to which fatigue affects the daily functions of MS patients.
Trunk Impairment Scale
It is used to evaluate trunk control.
Assessment of the Endurance of Core Muscles
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.
Assessment of the Strength of Core Muscles
It will be evaluated with "Sit-ups" and Modified "Push-ups" tests.

Secondary Outcome Measures

Kinesthetic and Visual Imagery Questionnaire
It is a tool used to assess individuals' imagery levels.
Movement Imagery Questionnaire-3
It is a tool used to assess individuals' imagery levels.
Mental Stopwatch
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).
Measurement of Muscle Oxygenation
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).

Full Information

First Posted
May 12, 2022
Last Updated
January 30, 2023
Sponsor
Hacettepe University
Collaborators
Bandırma Onyedi Eylül University
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1. Study Identification

Unique Protocol Identification Number
NCT05377476
Brief Title
Investigation of the Effects of Motor Imagery and Action Observation Training in Individuals With Multiple Sclerosis
Official Title
Investigation of the Effects of Motor Imagery and Action Observation Training on Walking, Fatigue, Trunk Control and Muscle Oxygenation in Individuals With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
Bandırma Onyedi Eylül University

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Motor Imagery Training, Action Observation Training, Walking, Fatigue, Trunk Control, Muscle Oxygenation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Motor Imagery Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Action Observation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
Individuals included in this group will receive only 40 minutes of standard rehabilitation. Patients will be trained 3 days a week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Motor Imagery training
Intervention Description
Individuals included in this group will receive 20 minutes of motor imagery training in addition to 40 minutes of standard rehabilitation.
Intervention Type
Other
Intervention Name(s)
Action Observation training
Intervention Description
Individuals included in this group will receive 20 minutes of action observation training in addition to 40 minutes of standard rehabilitation.
Intervention Type
Other
Intervention Name(s)
standard rehabilitation
Intervention Description
40 minutes of standard rehabilitation.
Primary Outcome Measure Information:
Title
6 Min Walking Test
Description
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.
Time Frame
6 week
Title
Timed Up and Go Test
Description
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.
Time Frame
6 week
Title
Dynamic Gait Index
Description
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.
Time Frame
6 week
Title
Multiple Sclerosis Walking Scale-12
Description
It is a scale used to measure walking capacity.
Time Frame
6 week
Title
RehaGait® (Hasomed, Magdeburg, Germany) Gait Analysis
Description
The device gives about the time-distance characteristics and kinematic data of the gait.
Time Frame
6 week
Title
Fatigue Severity Scale
Description
It is a scale that evaluates the extent to which fatigue affects the daily functions of MS patients.
Time Frame
6 week
Title
Trunk Impairment Scale
Description
It is used to evaluate trunk control.
Time Frame
6 week
Title
Assessment of the Endurance of Core Muscles
Description
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.
Time Frame
6 week
Title
Assessment of the Strength of Core Muscles
Description
It will be evaluated with "Sit-ups" and Modified "Push-ups" tests.
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Kinesthetic and Visual Imagery Questionnaire
Description
It is a tool used to assess individuals' imagery levels.
Time Frame
6 week
Title
Movement Imagery Questionnaire-3
Description
It is a tool used to assess individuals' imagery levels.
Time Frame
6 week
Title
Mental Stopwatch
Description
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).
Time Frame
6 week
Title
Measurement of Muscle Oxygenation
Description
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).
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melike Sumeyye Ozen, M.Sc.
Phone
506 153 06 06
Email
mcengiz@bandirma.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melike Sumeyye Ozen, M.Sc.
Organizational Affiliation
Bandırma Onyedi Eylül University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MELIKE S CENGİZ

12. IPD Sharing Statement

Plan to Share IPD
No

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

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