Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-05 @ 6:35 PM
Study NCT ID:
NCT07249866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Robotic Assisted Therapy on Hand Functions, Grip Strength and Proprioception in Children With Hemiplegia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D006429', 'term': 'Hemiplegia'}], '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'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009788', 'term': 'Occupational Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hand grip strength by hand held dynamometer', 'timeFrame': '8 weeks', 'description': 'the hand grip strength will be measured by hand held dynamometer'}, {'measure': 'hand functions ( fine motor precision and integration measured by Bruininks-Oseretsky Test of Motor Proficiency', 'timeFrame': '8 weeks', 'description': 'hand functions will be measured by Bruininks-Oseretsky Test of Motor Proficiency'}, {'measure': 'wrist joint proprioception by digital goniometer', 'timeFrame': '8 weeks', 'description': 'wrist joint position sense will be measured by digital goniometer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['robotic therapy', 'hand functions', 'hemiplegia', 'cerebral palsy'], 'conditions': ['Cerebral Palsy, Spastic']}, 'descriptionModule': {'briefSummary': 'Statement of the problem:\n\nDoes robotic assisted therapy have an effect on hand functions, grip strength and proprioception in children with hemiplegic cerebral palsy?\n\nSignificance of the study:\n\nNew technologies allow and promote active involvement, leading directly to functional changes that are far beyond those obtained with conventional therapy. Many features of robotic therapy may contribute to enhanced recovery of upper limb motor function. These include task-specific practice, intensity of repetition, robotic assistance, enhanced sensory feedback, continual motivation (because every trial yields a degree of success, even if robot assistance is required).\n\nThe implementation of robotics with hemiplegic cerebral palsy focuses on functional motor performance by providing intensive repetitive training, sensorimotor integration and cognitive engagement through goal-directed tasks to address the underlying symptoms. Robotic technologies offer numerous potential advantages over conventional therapies, chief among these being the ability to provide high-intensity repetitive training. Robotic treatment is a novel approach that has demonstrated promise in enhancing motor function, enhancing the quality of life, and lessening the burden on caregivers.', 'detailedDescription': 'Thirty two children with hemiplegic cerebral palsy from both sexes according to G\\*power analysis (α= 0.05 , Power= 0.90 , effect size = 0.89) Their ages range from 6- 9 years. Mild to moderate degree of spasticity, according to modified Ashworth scale (grade 1 to 2).\n\nMotor function level will be I and II according to gross motor function classification system.\n\nAssessment will be conducted using Bruininks Oseretsky test of motor proficiency scale 2nd edition (BOT-2) for assessment of fine motor control , handheld dynamometer will be used for measuring hand grip strength and digital goniometer for measuring wrist joint sense of position.\n\nChildren in the study group will receive robotic assisted therapy.\n\nNull Hypothesis:\n\nThere will be no effect of robotic assisted therapy on hand functions, grip strength and proprioception in children with hemiplegic cerebral palsy .\n\nBasic assumptions:\n\nAll children will attend the treatment program regularly. All children will follow the same sequence of the treatment procedure. All children will be cooperative and following the instructions during evaluation and treatment procedures.\n\nThe results of the study will be helpful for physical therapists dealing with children with the same condition\n\nInclusion Criteria:\n\nTheir ages range from 6-9 years. They have mild to moderate spasticity (grade 1- 2) according to Modified Ashworth Scale Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS Their manual abilities will be at level II and Level III according to Manual Ability classification system as mentioned in a previous review They will be able to understand and follow instructions\n\nExclusion criteria:\n\nFixed deformity in any joints of the upper limb. Previous history of surgical intervention in the upper limb. Auditory, visual and cognitive problems. Botulinum Toxin injection in last 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Their ages range from 6-9 years\n* They have mild to moderate spasticity (grade 1- 2) 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* Their manual abilities will be at level II and Level III according to Manual Ability classification system\n* They will be able to understand and follow instructions\n\nExclusion Criteria:\n\n* Fixed deformity in any joints of the upper limb.\n* Previous history of surgical intervention in the upper limb.\n* Auditory, visual and cognitive problems.\n* Botulinum Toxin injection in last 6 months.'}, 'identificationModule': {'nctId': 'NCT07249866', 'briefTitle': 'Effect of Robotic Assisted Therapy on Hand Functions, Grip Strength and Proprioception in Children With Hemiplegia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Robotic Assisted Therapy on Hand Functions, Grip Strength and Proprioception in Children With Hemiplegia', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005785'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic assisted therapy', 'description': 'robotic hand assisted therapy using robotic gloves for 8 weeks 3seesions / week each session lasts 30 minutes including passive , active assisted, active resisted, mirroring and gaming mode', 'interventionNames': ['Device: Hand rehabilitation robotic gloves', 'Other: occupational therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional occupational therapy', 'description': '3 sessions/ week for 8 weeks and each session lasts 30 minutes using scissors - Knocking peg board with hammer- Building towers with rings-- Cubes insertion into wide muzzle jars- Playing with clays and form small balls and rolls', 'interventionNames': ['Other: occupational therapy']}], 'interventions': [{'name': 'Hand rehabilitation robotic gloves', 'type': 'DEVICE', 'description': 'robotic gloves assist in hand functions', 'armGroupLabels': ['Robotic assisted therapy']}, {'name': 'occupational therapy', 'type': 'OTHER', 'description': 'designed traditional occupational therapy program', 'armGroupLabels': ['Robotic assisted therapy', 'Traditional occupational therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3387722', 'city': 'Cairo', 'state': 'State/Province', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Nour', 'role': 'CONTACT', 'email': 'drchess6@gmail.com', 'phone': '01127017865'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Nour ElDin Hassan, assistant lecturer', 'role': 'CONTACT', 'email': 'mohamed.nooreldien@nub.edu.eg', 'phone': '00201127011865'}], 'overallOfficials': [{'name': 'Samah Attia El shemy, professor doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo university, Faculty of physical therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'any participant data will be available on direct request from authors'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor and chairman of department of physical therapy for pediatrics', 'investigatorFullName': 'Samah Attia El Shemy', 'investigatorAffiliation': 'Cairo University'}}}}