Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 6:03 AM
Study NCT ID:
NCT07347795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2025-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Blood Flow Restriction Training Exercises on Hand Grip Strength in Hemiparetic Cerebral Palsied Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2025-12-31', 'studyFirstSubmitQcDate': '2026-01-11', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hand grip strength measured using a handheld dynamometer', 'timeFrame': '8 weeks', 'description': 'Hand grip strength of the affected hand will be assessed using a calibrated handheld dynamometer. The maximum voluntary grip force will be recorded in kilograms (kg). Three trials will be performed, and the highest value will be used for analysis.'}, {'measure': 'muscle thickness at the midpoint of the forearm flexor muscles', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy Spastic Hemiplegic']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the effect of blood flow restriction (BFR) training exercises on the hand grip strength of children with hemiparetic cerebral palsy. Hand grip strength is a vital component of motor function and is often severely compromised in children with hemiparetic CP, which can significantly impact their daily activities and quality of life. Blood flow restriction (BFR) training is a novel exercise technique where a cuff or band is used to partially occlude blood flow during low-intensity resistance exercises. This method has been shown to stimulate muscle growth and strength gains similar to those achieved through high-intensity strength training, without the need for high loads. Given the unique physiological challenges faced by children with hemiparetic CP, BFR training could provide an effective alternative to traditional strength training methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge will range from 6-12 years\n\n* Diagnosed with hemiparetic cerebral palsy (right or left side).\n* According to Modified Ashwer scale, has grade 1 or 1+ grade\n* Children with the ability to understand and follow verbal commands and instructions used during training and tests\n\nExclusion Criteria:\n\n* Any contraindications to exercise, such as moderate or severe spasticity, orthopedic deformities, or other serious health conditions.'}, 'identificationModule': {'nctId': 'NCT07347795', 'briefTitle': 'Effect of Blood Flow Restriction Training Exercises on Hand Grip Strength in Hemiparetic Cerebral Palsied Children', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Blood Flow Restriction Training and Hand Grip Strength in Hemiparetic CP', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005952'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The control group performs traditional hand grip strengthening exercises, focusing on similar exercises but without blood flow restriction. Both groups participate in a similar frequency and duration of training, with a gradual increase in repetitions over the 8 weeks', 'interventionNames': ['Behavioral: control group']}, {'type': 'EXPERIMENTAL', 'label': 'Study group', 'interventionNames': ['Device: Blood Flow Restriction Training Exercises group']}], 'interventions': [{'name': 'Blood Flow Restriction Training Exercises group', 'type': 'DEVICE', 'description': "The BFR group underwent BFR training for 8 weeks, with sessions held three times per week. A tourniquet-style cuff is placed on the upper arm to restrict blood flow during exercise. The exercises involved are low-intensity grip strengthening activities (e.g., squeezing a rubber ball, gripping a hand dynamometer) at 20% of their one-repetition maximum (1RM). The cuff pressure is set at 50-70% of the participants' limb occlusion pressure, as determined by an initial assessment.", 'armGroupLabels': ['Study group']}, {'name': 'control group', 'type': 'BEHAVIORAL', 'description': 'The control group performs traditional hand grip strengthening exercises, focusing on similar exercises but without blood flow restriction. Both groups participate in a similar frequency and duration of training, with a gradual increase in repetitions over the 8 weeks.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'contacts': [{'name': 'Cairo university Cairo university', 'role': 'CONTACT', 'email': 'rsm211_pt@cu.edu.eg', 'phone': '00201015447798'}], 'facility': 'Cairo Universit', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Alsakhawi', 'role': 'CONTACT', 'email': 'rsm211_pt@yahoo.com', 'phone': '00966504182628'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Reham Saeed Alsakhawi', 'investigatorAffiliation': 'Cairo University'}}}}