Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-26 @ 8:35 AM
Study NCT ID:
NCT06676332
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2024-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Multisensory Motor Imagery Training on Muscle Performance and Coordination in Children With Spastic Diplegia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-15', 'studyFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle performance', 'timeFrame': 'through study completion average 3 months', 'description': 'muscle performance of knee and trunk muscles will be assessed by Isokinetic dynamometer'}, {'measure': 'coordination', 'timeFrame': 'through study completion average 3 months', 'description': 'coordination ill be assessed using BOT-2'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spastic Diplegia', 'Motor Imagery']}, 'descriptionModule': {'briefSummary': 'PURPOSE:\n\nThe current study aims to:\n\n* Determine the effect of multisensory motor imagery training on muscle performance including (peak torque, work, power) of trunk and knee flexors and extensors in children with spastic diplegia.\n* Determine the effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia.\n\nBACKGROUND: Multisensory motor imagery training has an effect on muscle performance and coordination in children with spastic diplegia\n\nHYPOTHESES: There will be no effect of multisensory motor imagery training on muscle performance, coordination and strength and agility in children with spastic diplegic CP.\n\nRESEARCH QUESTION: Is there an effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Their age will be ranged from 8-12 years.\n* Mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale\n* Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS\n* They will be able to follow instructions during evaluation and treatment.\n\nExclusion Criteria:\n\n* \\- Cardiovascular or respiratory disorders.\n* Botulinium muscular injection in the last 6 months\n* Surgical interference in lower limbs and/or spine.\n* Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.\n* Seizures.\n* Visual or hearing impairment'}, 'identificationModule': {'nctId': 'NCT06676332', 'briefTitle': 'Effect of Multisensory Motor Imagery Training on Muscle Performance and Coordination in Children With Spastic Diplegia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Multisensory Motor Imagery Training on Muscle Performance and Coordination in Children With Spastic Diplegia', 'orgStudyIdInfo': {'id': '005278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'control', 'description': 'traditional physical therapy program', 'interventionNames': ['Other: traditional physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'motor imagery', 'description': 'multisensory motor imagery training plus the traditional physical therapy program', 'interventionNames': ['Other: motor imagery training', 'Other: traditional physical therapy']}], 'interventions': [{'name': 'motor imagery training', 'type': 'OTHER', 'otherNames': ['mental rehearsal exercises'], 'description': 'Children in the study group will receive multisensory motor imagery training program 45 minutes. The training protocol consists of several parts that will be run through every training session according to Kumar et al. (2016):\n\n* Watching videos of selected multisensory motor skills for 10 minutes.\n* Mental rehearsal of these motor skills 10 minutes.\n* Overt practice of the multisensory motor skills for 25 minutes. On the videos, the performance of the skill by a child aged 8-12 years will be shown. All the exercises will be looped to repeat for six to seven times. While projecting the video on the laptop screen, it will be ensured that the children are in a comfortable seating position and the screen is in their visual field. Repetition of the exercises was based on their ability which could be a minimum of five repetitions per session to a maximum of ten repetitions per exercise session.', 'armGroupLabels': ['motor imagery']}, {'name': 'traditional physical therapy', 'type': 'OTHER', 'description': 'traditional physical therapy training program', 'armGroupLabels': ['control', 'motor imagery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Mayada Elshahawy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mayada Elshahawy', 'role': 'CONTACT', 'email': 'myadashahawy11@gmail.com', 'phone': '0201095022909'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Effect of multisensory motor imagery training on muscle performance and coordination in children with spastic diplegia', 'investigatorFullName': 'Mayada Ibraheem Elmahdy', 'investigatorAffiliation': 'Cairo University'}}}}