Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-04 @ 2:12 PM
Study NCT ID:
NCT07248735
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of CIMT With and Without Robotic Gloves in Children With Hemiplegic CP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002658', 'term': 'Developmental Disabilities'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grip Strength Test', 'timeFrame': '4-8 weeks', 'description': "The grip strength test and pinch strength is used to assess function of the hand using dynamometer. Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength"}, {'measure': 'Box and Block Test', 'timeFrame': '4-8 weeks', 'description': 'The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. The BBT is composed of a wooden box divided in two EFFECTS OF CIMT WITH AND WITHOUT ROBOTIC GLOVES IN CHILDREN WITH HEMIPLEGIC CP 11 compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CIMT, Robotic Gloves, Dexterity, Hemiplegic CP'], 'conditions': ['Child Development Disorder']}, 'referencesModule': {'references': [{'pmid': '32138780', 'type': 'BACKGROUND', 'citation': 'Osuagwu BAC, Timms S, Peachment R, Dowie S, Thrussell H, Cross S, Shirley R, Segura-Fragoso A, Taylor J. Home-based rehabilitation using a soft robotic hand glove device leads to improvement in hand function in people with chronic spinal cord injury:a pilot study. J Neuroeng Rehabil. 2020 Mar 5;17(1):40. doi: 10.1186/s12984-020-00660-y.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks.', 'detailedDescription': 'Hemiplegic cerebral palsy (CP) often affects one side of the body, limiting functional abilities. Constraint-Induced Movement Therapy (CIMT) is a common intervention where the unaffected hand is restricted to encourage the use of the affected hand. Recently, the addition of robotic gloves has been proposed to improve outcomes, as they offer mechanical support and feedback to the affected hand. This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-12 years with Hemiplegic CP.\n* Both Genders will be included.\n* Fulfilling the CIMT criteria i.e. Up to 20 Degree Wrist Extension, up to 10 Degree\n* Thumb Abduction and Up to 10 Degree Finger Extension.\n* GMFCS level of 1 and 2.\n* MAC Grade 2 and 3.\n* Ability to understand and follow simple instructions.\n\nExclusion Criteria:\n\n* Severe cognitive impairment or intellectual disability.\n* Presence of other neurological disorders such as epilepsy.\n* Children currently participating in other intensive physical therapy programs.'}, 'identificationModule': {'nctId': 'NCT07248735', 'briefTitle': 'Effects of CIMT With and Without Robotic Gloves in Children With Hemiplegic CP', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Constraint Induced Movement Therapy With and Without Robotic Glove on Dexterity and Hand Grip Strength in Children With Hemiplegic Cerebral Palsy', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/AFTAB ANSAR LODHI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Experimental group', 'interventionNames': ['Other: CIMT with robotic glove']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Control group', 'interventionNames': ['Other: CIMT with standard rehabilitation']}], 'interventions': [{'name': 'CIMT with robotic glove', 'type': 'OTHER', 'description': 'The Experimental group undergoes a comprehensive rehabilitation program, combining Constraint-Induced Movement Therapy (CIMT) with robotic glove therapy. The unaffected limb is restrained by the help of Slings, Simple glove, splint or plaster. Each session lasts 6 Hours, occurring 3-5 Days a weekly, over a period of 4-8 weeks. This intensive regimen aims to enhance hand function and mobility by constraining the unaffected hand while using the robotic glove to facilitate precise finger movements.', 'armGroupLabels': ['Group A']}, {'name': 'CIMT with standard rehabilitation', 'type': 'OTHER', 'description': 'Controlled group receives CIMT with baseline rehabilitation. Only receives CIMT without Robotic Gloves. Additional assessments may be conducted after 3 or 6 months to measure long-term effects.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5400', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhmmad Asif Javed, MS', 'role': 'CONTACT', 'email': 'a.javed@ripah.edu.pk', 'phone': '033224209422'}, {'name': 'Aftab Ansar Lodhi, MS-PT', 'role': 'CONTACT', 'email': 'aftabansarlodhi@gmail.com', 'phone': '03128575174'}], 'facility': 'Imran Amjad', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Imran Amjad, PhD', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '9233224390125'}, {'name': 'Muhammad Asif Javed, MS-PT', 'role': 'CONTACT', 'email': 'a.javed@riphah.edu.pk', 'phone': '923224209422'}], 'overallOfficials': [{'name': 'Aftab Ansar Lodhi, MS-PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}