- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05526612
The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34010
- Biruni University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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 |
|---|---|
|
Active Comparator: Group 1
Motor imagery and Bobath Therapeutic Approach (BTA+MI)
|
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.
|
|
Experimental: Group 2
Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Fugl-Meyer Upper Extremity Scale (FMUE)
Time Frame: The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
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. |
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
|
Time in minutes to perform a motor task
Time Frame: The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
The video will be recorded while the patient is performing the eating activity.
|
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
|
The Motor Activity Log-28 (MAL-28)
Time Frame: The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
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.
|
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
|
Wolf Motor Function Test (WMFT)
Time Frame: The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
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.
|
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic Characteristic of Participants
Time Frame: 1 week before the first treatment session
|
The general demographic information of participants such as gender, age, body mass index will be recorded in a form created by investigators.
|
1 week before the first treatment session
|
|
Assessment of Quality of Life
Time Frame: The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
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 first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
|
The Brunnstrom Stages
Time Frame: Baseline
|
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.
|
Baseline
|
|
Spasticity Evaluation
Time Frame: Baseline
|
Modified Ashworth Scale (MAS) It is used to measure spasticity which ranges from 0-4. |
Baseline
|
|
The Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time Frame: The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
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.
|
The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-SOYSAL-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Stroke
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
University Hospital HeidelbergCompletedAcute Ischemic Stroke | Acute Ischemic Stroke AIS | Acute Ischemic Stroke PatientsGermany