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The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke

Primary Purpose

Stroke

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI)
Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Motor imagery, Physical practice, Bobath therapeutic approach

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A maximum of 24 months have passed since the stroke,
  • Unilateral involvement,
  • Getting a score of 21 and above in the Mini Mental Test,
  • Getting a score of 22 and above in the Fugl-Meyer Test,
  • Ability to understand and follow simple verbal commands,
  • Stage 4 or 5 according to Brunnstrom Upper Extremity Stages,
  • Spasticity 1 or 1+ according to the Modified Ashworth Scale,
  • Having signed the Informed Consent Form.

Exclusion Criteria:

  • Patients with visual and hearing impairments that would interfere with work.
  • Having pain and limitation of joint movement that may prevent performing the given tasks.
  • Having any neurological disorder other than stroke.

Sites / Locations

  • Biruni University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

Motor imagery and Bobath Therapeutic Approach (BTA+MI)

Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)

Outcomes

Primary Outcome Measures

The Fugl-Meyer Upper Extremity Scale (FMUE)
Fugl-Meyer upper extremity (FMUE) Scale scores is an index to assess the sensorimotor impairment in individuals who had stroke. The motor section score ranges from 0 to 66, and the score related to exteroceptive and proprioceptive sensitivity ranges from 0 to 12. The lowest and highest scores correspond to worse and better function.
Time in minutes to perform a motor task
The video will be recorded while the patient is performing the eating activity.
The Motor Activity Log-28 (MAL-28)
Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks. When administering the WMFT, the examiner should test the less-affected UE followed by the most affected side. Items should be performed as quickly as possible; a maximum of 120 second per task is allowed . The first 6 items involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks.

Secondary Outcome Measures

Demographic Characteristic of Participants
The general demographic information of participants such as gender, age, body mass index will be recorded in a form created by investigators.
Assessment of Quality of Life
Nottingham Extended Activities of Daily Living (NEADL) It is a simple, self-administered questionnaire that can be completed by the patient in approximately 10 min; it provides an extended ADL score that is highly correlated with more complex, self-reported interviewer-administered measures of disability.
The Brunnstrom Stages
The brunnstrom stages is one of the most well-known stroke recovery stages which is also known as the Brunnstrom approach. The motor recovery of hemiplegia was classified by Brunnstrom in 6 stages.
Spasticity Evaluation
Modified Ashworth Scale (MAS) It is used to measure spasticity which ranges from 0-4.
The Kinesthetic and Visual Imagery Questionnaire (KVIQ)
The KVIQ assesses on a five-point ordinal scale the clarity of the image (visual: V subscale) and the intensity of the sensations (kinesthetic: K subscale) that the subjects are able to imagine from the first-person perspective.

Full Information

First Posted
August 31, 2022
Last Updated
September 2, 2022
Sponsor
Biruni University
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1. Study Identification

Unique Protocol Identification Number
NCT05526612
Brief Title
The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke
Official Title
The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
August 13, 2022 (Actual)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni 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
The aim of the study is to compare the effects of specific functional task-oriented motor imagery training combined with the Bobath Therapeutic Approach and physical practice after imagery on upper extremity motor function in stroke patients.
Detailed Description
Motor imagery (MI) is the mental rehearsal of motor abilities to improve function. Thus, imagery provides both the learning of the new movement and the improvement of the quality of movement by repeating the known activities.the investigators These neurophysiological findings obtained in recent years have popularized the use of motor imagery approach in the rehabilitation of stroke patients. 32 stroke patients aged 50-75 years will be included in the study. Cases will be randomized into 2 groups. In our study, a treatment program will be applied with a physiotherapist for a total of 8 weeks, 2 days a week. The first group in the treatment program; Motor imagery will be performed with the Bobath Therapeutic Approach (BTA+MI) and the second group will be physical practice of imagery activities after motor imagery with the Bobath Therapeutic Approach (BTA+MI+PP). Motor imagery activity was determined as 'eating activity'. The desired goal as a result of our work; the investigators think that motor imagery training on eating activity of stroke patients and physical practice used together will improve both the achievement of eating activity and upper extremity motor function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Motor imagery, Physical practice, Bobath therapeutic approach

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Motor imagery and Bobath Therapeutic Approach (BTA+MI)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)
Intervention Type
Other
Intervention Name(s)
Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI)
Intervention Description
Motor imagery (MI) is the mental rehearsal of motor abilities to improve function. Without revealing any movement in the body, the representation of the movement is created in the mind, the person imagines that he/she is performing the movement. Eating activity will be applied in motor imagery. Individualized therapy sessions in the Bobath Therapeutic Approach will also be received by the Physiotherapist along with Motor imagery. 2 days a week, 30 minutes session will be applied for a total of 8 weeks.
Intervention Type
Other
Intervention Name(s)
Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)
Intervention Description
Individualized therapy sessions in the Bobath Therapeutic Approach with motor imagery will be performed by the physiotherapist, and in addition to these, 5 repetitions of the eating activity used in motor imagery will be practiced. 2 days a week, 30 minutes session will be applied for a total of 8 weeks.
Primary Outcome Measure Information:
Title
The Fugl-Meyer Upper Extremity Scale (FMUE)
Description
Fugl-Meyer upper extremity (FMUE) Scale scores is an index to assess the sensorimotor impairment in individuals who had stroke. The motor section score ranges from 0 to 66, and the score related to exteroceptive and proprioceptive sensitivity ranges from 0 to 12. The lowest and highest scores correspond to worse and better function.
Time Frame
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
Title
Time in minutes to perform a motor task
Description
The video will be recorded while the patient is performing the eating activity.
Time Frame
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
Title
The Motor Activity Log-28 (MAL-28)
Description
Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
Time Frame
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
Title
Wolf Motor Function Test (WMFT)
Description
The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks. When administering the WMFT, the examiner should test the less-affected UE followed by the most affected side. Items should be performed as quickly as possible; a maximum of 120 second per task is allowed . The first 6 items involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks.
Time Frame
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
Secondary Outcome Measure Information:
Title
Demographic Characteristic of Participants
Description
The general demographic information of participants such as gender, age, body mass index will be recorded in a form created by investigators.
Time Frame
1 week before the first treatment session
Title
Assessment of Quality of Life
Description
Nottingham Extended Activities of Daily Living (NEADL) It is a simple, self-administered questionnaire that can be completed by the patient in approximately 10 min; it provides an extended ADL score that is highly correlated with more complex, self-reported interviewer-administered measures of disability.
Time Frame
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
Title
The Brunnstrom Stages
Description
The brunnstrom stages is one of the most well-known stroke recovery stages which is also known as the Brunnstrom approach. The motor recovery of hemiplegia was classified by Brunnstrom in 6 stages.
Time Frame
Baseline
Title
Spasticity Evaluation
Description
Modified Ashworth Scale (MAS) It is used to measure spasticity which ranges from 0-4.
Time Frame
Baseline
Title
The Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Description
The KVIQ assesses on a five-point ordinal scale the clarity of the image (visual: V subscale) and the intensity of the sensations (kinesthetic: K subscale) that the subjects are able to imagine from the first-person perspective.
Time Frame
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A maximum of 24 months have passed since the stroke, Unilateral involvement, Getting a score of 21 and above in the Mini Mental Test, Getting a score of 22 and above in the Fugl-Meyer Test, Ability to understand and follow simple verbal commands, Stage 4 or 5 according to Brunnstrom Upper Extremity Stages, Spasticity 1 or 1+ according to the Modified Ashworth Scale, Having signed the Informed Consent Form. Exclusion Criteria: Patients with visual and hearing impairments that would interfere with work. Having pain and limitation of joint movement that may prevent performing the given tasks. Having any neurological disorder other than stroke.
Facility Information:
Facility Name
Biruni University
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke

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