Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05302102
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2022-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Unilateral Versus Bilateral Lower-Limb Plyometric Training in Children With Cerebral Palsy
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This was a single-blind protocol. The researcher who collected the data was blinded to the treatment allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-03', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spatial gait symmetry', 'timeFrame': '2 months', 'description': 'The spatial gait symmetry index was measured about the step length of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.'}, {'measure': 'Temporal gait symmetry', 'timeFrame': '2 months', 'description': 'The temporal gait symmetry index was measured about the single-limb support time of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern'}, {'measure': 'Limit of postural stability', 'timeFrame': '2 months', 'description': 'The capacity to control and move the center-of-gravity in various directions across their base-of-support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'This study was set out to compare the effect of paretic-limb-only plyometric training versus double-limb training on balance capability and gait symmetry in adolescents with unilateral cerebral palsy (U-CP). Sixty-nine children with U-CP were randomly allocated to the paretic-limb-only plyometric training group (n = 23; performed plyometric movements/exercises unilaterally using the paretic leg only), the double-limb plyometric training group (n = 23; performed plyometric movements/exercises bilaterally through both lower legs), or the Control group (n =23, received standard rehabilitation plus SSC exercises). All groups were assessed for gait-symmetry and balance capability pre and post-treatment.', 'detailedDescription': 'Sixty-nine children with U-CP were recruited from the Physical Therapy Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 12 and 18 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, had attentional neglect, and if they had cardiopulmonary problems preventing them from performing high-intense exercise training.\n\nOutcome measures\n\n* Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAITRite system.\n* Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.\n\nAll groups were trained for 45 minutes, twice per week, for 12 successive weeks. The paretic-limb-only plyometric training group performed plyometric movements/exercises unilaterally using the paretic leg only. The double-limb plyometric training group performed plyometric movements/exercises bilaterally through both lower legs. The plyometric training program consisted of five unilateral and five bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities. The plyometric training was preceded by a warm-up for 5 minutes and ended up with a 5-min cooldown. The control group received the standard rehabilitation program, which comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral cerebral palsy\n* Age 12-18 years\n* Motor function level I or II according to the Gross Motor Function Classification System.\n* Spasticity level 1 or 1+ according to the Modified Ashworth Scale\n\nExclusion Criteria:\n\n* Structural deformities/contractures\n* Musculoskeletal or neural surgery in the last year\n* BOTOX injection in the last 6 months.\n* Cardiopulmonary disorders that interfere with the ability to engage in exercise training.\n* Perceptual and/or behavioral disorders.'}, 'identificationModule': {'nctId': 'NCT05302102', 'briefTitle': 'Unilateral Versus Bilateral Lower-Limb Plyometric Training in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Paretic-limb-only Plyometric Training Versus Volume-matched Double-limb Training for Ameliorating Balance Capability and Gait Symmetry in Adolescents With Unilateral Cerebral Palsy: A Comparative Study', 'orgStudyIdInfo': {'id': 'RHPT/0019/0013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paretic-limb-only plyometric training group', 'description': 'Participants in this group performed plyometric movements/exercises unilaterally using the paretic leg.', 'interventionNames': ['Other: Unilateral plyometric training']}, {'type': 'EXPERIMENTAL', 'label': 'Doule-limb plyometric training', 'description': 'Participants in this group performed plyometric movements/exercises bilaterally through the paretic and non-paretic legs.', 'interventionNames': ['Other: Bilateral plyometric training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants in this group received the standard physical rehabilitation program.', 'interventionNames': ['Other: Standard physical therapy']}], 'interventions': [{'name': 'Unilateral plyometric training', 'type': 'OTHER', 'description': 'The paretic-limb-only plyometric training group received a plyometric exercise program performed unilaterally through the paretic leg only for 45 minutes, three times per week for 12 successive weeks. The training was conducted under close supervision of a licensed pediatric physical therapist according to safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association.', 'armGroupLabels': ['Paretic-limb-only plyometric training group']}, {'name': 'Bilateral plyometric training', 'type': 'OTHER', 'description': 'The double-limb plyometric training group received a plyometric exercise program performed bilaterally through the paretic and non-paretic legs for 45 minutes, three times per week for 12 successive weeks. The training was conducted under close supervision of a licensed pediatric physical therapist according to safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association.', 'armGroupLabels': ['Doule-limb plyometric training']}, {'name': 'Standard physical therapy', 'type': 'OTHER', 'description': 'The control group received the standard physical rehabilitation program conducted for 45 minutes, thrice a week for 12 consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Kharj', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'Ragab K. Elnaggar', 'geoPoint': {'lat': 24.15541, 'lon': 47.33457}}], 'overallOfficials': [{'name': 'Ragab K Elnaggar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prince Sattam Bin Abdulaziz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ragab Kamal Elnaggar', 'investigatorAffiliation': 'Cairo University'}}}}