StrokeNCT05526612
The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke
A study testing Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI) and Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP) in people with Stroke, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI) and Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jul 2022to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI), Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)
- Keywords
- Stroke, Motor imagery, Physical practice, Bobath therapeutic approach
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI)Other
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.
Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Motor imagery and Bobath Therapeutic Approach (BTA+MI) Receives: Other: Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI) |
| Group 2 | Experimental | Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP) Receives: Other: Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The video will be recorded while the patient is performing the eating activity.
Measured: 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)
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.
Measured: The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
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.
Measured: The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
Secondary outcomes (5)
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.
Measured: 1 week before the first treatment session
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.
Measured: The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
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.
Measured: Baseline
Spasticity Evaluation
Modified Ashworth Scale (MAS)
It is used to measure spasticity which ranges from 0-4.
Measured: Baseline
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.
Measured: The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start13 Jul 2022
- Primary completion13 Aug 2022
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment (Outcomes Assessor)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisa Nur SOYSAL, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526612
- Sponsor's protocol ID
- B-SOYSAL-001
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05526612
- Acronym / sponsor ID
- B-SOYSAL-001
- Conditions
- Stroke
- Keywords
- Stroke, Motor imagery, Physical practice, Bobath therapeutic approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 13 Aug 2022 (actual)
- Study completion
- Jan 2023 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment (Outcomes Assessor)
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI)Motor imagery and Bobath Therapeutic Approach (BTA+MI) |
| Group 2 | Experimental | Other: Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group 1 |
| 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. | Other | Group 2 |
Primary outcome
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.
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 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.
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.
5 secondary outcomes
Demographic Characteristic of Participants
Time frame: 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
The Brunnstrom Stages
Time frame: Baseline
Spasticity Evaluation
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI) and Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP) in people with Stroke, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.