Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05526612
Status:
UNKNOWN
Last Update Posted:
2022-09-07
First Post:
2022-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-02', 'size': 114065, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-09-02T05:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment (Outcomes Assessor)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-02', 'studyFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Fugl-Meyer Upper Extremity Scale (FMUE)', 'timeFrame': 'The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation', 'description': 'Fugl-Meyer upper extremity (FMUE) Scale scores is an index to assess the sensorimotor impairment in individuals who had stroke.\n\nThe 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.'}, {'measure': 'Time in minutes to perform a motor task', 'timeFrame': 'The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation', 'description': 'The video will be recorded while the patient is performing the eating activity.'}, {'measure': 'The Motor Activity Log-28 (MAL-28)', 'timeFrame': 'The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation', '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."}, {'measure': 'Wolf Motor Function Test (WMFT)', 'timeFrame': 'The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation', '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.'}], 'secondaryOutcomes': [{'measure': 'Demographic Characteristic of Participants', 'timeFrame': '1 week before the first treatment session', 'description': 'The general demographic information of participants such as gender, age, body mass index will be recorded in a form created by investigators.'}, {'measure': 'Assessment of Quality of Life', 'timeFrame': 'The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation', 'description': 'Nottingham Extended Activities of Daily Living (NEADL)\n\nIt 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.'}, {'measure': 'The Brunnstrom Stages', 'timeFrame': 'Baseline', '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.'}, {'measure': 'Spasticity Evaluation', 'timeFrame': 'Baseline', 'description': 'Modified Ashworth Scale (MAS)\n\nIt is used to measure spasticity which ranges from 0-4.'}, {'measure': 'The Kinesthetic and Visual Imagery Questionnaire (KVIQ)', 'timeFrame': 'The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Motor imagery', 'Physical practice', 'Bobath therapeutic approach'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\n32 stroke patients aged 50-75 years will be included in the study. Cases will be randomized into 2 groups.\n\nIn 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'.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A maximum of 24 months have passed since the stroke,\n* Unilateral involvement,\n* Getting a score of 21 and above in the Mini Mental Test,\n* Getting a score of 22 and above in the Fugl-Meyer Test,\n* Ability to understand and follow simple verbal commands,\n* Stage 4 or 5 according to Brunnstrom Upper Extremity Stages,\n* Spasticity 1 or 1+ according to the Modified Ashworth Scale,\n* Having signed the Informed Consent Form.\n\nExclusion Criteria:\n\n* Patients with visual and hearing impairments that would interfere with work.\n* Having pain and limitation of joint movement that may prevent performing the given tasks.\n* Having any neurological disorder other than stroke.'}, 'identificationModule': {'nctId': 'NCT05526612', 'briefTitle': 'The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Biruni University'}, 'officialTitle': 'The Effects of Motor Imagery Training and Physical Practice on Upper Extremity Motor Function in Patients With Stroke', 'orgStudyIdInfo': {'id': 'B-SOYSAL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Motor imagery and Bobath Therapeutic Approach (BTA+MI)', 'interventionNames': ['Other: Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)', 'interventionNames': ['Other: Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)']}], 'interventions': [{'name': 'Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI)', 'type': 'OTHER', '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.', 'armGroupLabels': ['Group 1']}, {'name': 'Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)', 'type': 'OTHER', '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.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34010', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Biruni University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biruni University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator,Physical Therapist', 'investigatorFullName': 'Nisa Nur SOYSAL', 'investigatorAffiliation': 'Biruni University'}}}}