Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:53 AM
Study NCT ID:
NCT07338994
Status:
COMPLETED
Last Update Posted:
2026-01-14
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TENS With Proprioceptive-Visual Training on Gait Parameters in CP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Electrical stimulation will be delivered by means of self-adherent surface electrodes (Encore plus), using a programmable electrical stimulator, providing monophasic rectangular pulse trains. Electrodes were attached over the belly of the rectus femoris and tibialis anterior muscles. The quadriceps and the dorsiflexors were selected due to their dominance in establishing a normal and efficient gait. TENS was applied for 20 minutes during gait training. The parameters selected for the electrical stimulation will be as follows: frequency 20Hz, pulse-width 0.25 msec, and intensity will be individually adjusted for each subject'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cadence', 'timeFrame': '8 weeks', 'description': 'investigators measure cadence'}, {'measure': 'step length and width', 'timeFrame': '8 weeks', 'description': 'investigators measure step length, width'}, {'measure': 'gait velocity', 'timeFrame': '8 weeks', 'description': 'investigators measure gait velocity'}, {'measure': 'gait time', 'timeFrame': '8 weeks', 'description': 'investigators measure gait time'}, {'measure': 'foot angle', 'timeFrame': '8 weeks', 'description': 'investigators measure foot angle'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spastic diplegia', 'visual training', 'proprioceptive stimulation', 'gait', 'Tekscan Walkway', 'TENS'], 'conditions': ['Cerebral Palsy (CP)']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the effect of TENS with proprioceptive - visual training on gait parameters in children with spastic diplegic cerebral palsy.', 'detailedDescription': 'Two groups of thirty diplegic CP children, ages 4 to 6, were randomly assigned to receive proprioceptive-visual training as the control group and TENS with proprioceptive - visual training as the research group. For eight weeks, both groups received therapy three times a week. Prior to and during the intervention period, each participant had an evaluation by gait analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diplegic CP children who were between the ages of 4 and 6 years\n* spasticity grades were 1 and 1+ according to modified Ashworth Scale\n* gross motor function classification system at level II and III\n\nExclusion Criteria:\n\n* Children who have visual impairments, hearing damage\n* received Botulinum Toxin injections or oral antispasticity medications within the past 6 months\n* fixed deformities at lower limbs\n* inability to understand the task'}, 'identificationModule': {'nctId': 'NCT07338994', 'briefTitle': 'TENS With Proprioceptive-Visual Training on Gait Parameters in CP', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'TENS With Proprioceptive-Visual Training on Gait Parameters in Children With Spastic Diplegic Cerebral Palsy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/006102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'receive proprioceptive-visual training', 'interventionNames': ['Device: 1. Tekscan Walkway system']}, {'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'TENS with proprioceptive - visual training', 'interventionNames': ['Device: TENS', 'Device: 1. Tekscan Walkway system']}], 'interventions': [{'name': 'TENS', 'type': 'DEVICE', 'description': 'Electrical stimulation will be delivered by means of self-adherent surface electrodes (Encore plus), using a programmable electrical stimulator, providing monophasic rectangular pulse trains. Electrodes were attached over the belly of the rectus femoris and tibialis anterior muscles. The quadriceps and the dorsiflexors were selected due to their dominance in establishing a normal and efficient gait. TENS was applied for 20 minutes during gait training. The parameters selected for the electrical stimulation will be as follows: frequency 20Hz, pulse-width 0.25 msec, and intensity will be individually adjusted for each subject', 'armGroupLabels': ['study group']}, {'name': '1. Tekscan Walkway system', 'type': 'DEVICE', 'description': "It includes sensors (4 sensels/cm2) with a resolution of up to 185 Hz, a digital mat (195.5 cm long by 44.2 cm wide) placed in a wooden pathway, and a pressure sensor (1 to 862 kPa). The plasma screen faces the walkway and is 1.5 meters high and 7 meters away. It displays pictures that are mirrored from seven pressure points (forming the contour of the foot). if the foot's heel, midfoot, forefoot, fifth metatarsal, third-fourth, second, and first metatarsals are the seven areas of pressure. Data such as maximum peak pressure (kPa), stance time (s), cadence, gait time (s), distance (cm), velocity (cm/s), and transmission hardware (cable and sensor-interface or so-called handle) will be extrapolated using a computer running The Tekscan Software (version 7).", 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'mostafa ali, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'associate professor for pediatrics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'faculty of physical therapy, cairo university', 'investigatorFullName': 'Mostafa S Ali', 'investigatorAffiliation': 'Cairo University'}}}}