Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT03124628
Status:
WITHDRAWN
Last Update Posted:
2020-09-02
First Post:
2017-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Flywheel Exercise on Muscle and Walking Function in Teenagers and Young Adults 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle performance', 'timeFrame': 'Change from pre- to post-intervention (8 wks)', 'description': 'Unilateral maximal voluntary isometric force is measured in both legs with force sensors. Similarly, unilateral (both legs) concentric and eccentric peak power is assessed through an encoder system. Furthermore, dynamic force during concentric and eccentric actions is measured via force sensors.'}, {'measure': 'Muscle architecture', 'timeFrame': 'Change from pre- to post-intervention (8 wks)', 'description': 'Vastus lateralis muscle thickness, together with fascicle pennation angle and muscle echogenicity, will be assessed using ultrasound technique in both legs. Thigh circumference will be assessed using measurement tape.'}, {'measure': 'Electromyography of lower limb muscles', 'timeFrame': 'Change from pre- to post-intervention (8 wks)', 'description': 'Muscle activation (mV) will be assessed in lower limb muscles (i.e. vastus lateralis, biceps femoris, gluteus medius, medial gastrocnemius) using surface electromyography techniques'}, {'measure': 'Assessment of activities of daily living', 'timeFrame': 'Change from pre- to post-intervention (8 wks)', 'description': 'Assessment of activities of daily living is measured using the Timed Up-and-Go test, the Chair-stand and the 6-min walking test.'}, {'measure': 'Gait performance adaptations to training including muscle activation and co-contraction during walking', 'timeFrame': 'Change from pre- to post-intervention (8 wks)', 'description': "Gait performance will be analyzed using an 8-camera 3-D kinematic VICON system and force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital. Overall gait pathology will also be assessed using the multivariate Gait Deviation Index. Muscle activation and co-contraction during gait will be assessed using wireless surface electromyography"}, {'measure': 'Gross motor function', 'timeFrame': 'Change from pre- to post-intervention (8 wks)', 'description': 'Gross motor function will be assessed using Gross Motor Function Measure (GMFM)'}, {'measure': 'Balance', 'timeFrame': 'Change from pre- to post-intervention (8 wks)', 'description': "Static and dynamic balance is assessed using force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital"}, {'measure': 'Muscle spasticity', 'timeFrame': 'Change from pre- to post-intervention (8 wks)', 'description': 'Spasticity will be assessed using the Ashworth scale'}], 'secondaryOutcomes': [{'measure': 'Subcutaneous fat thickness', 'timeFrame': 'Change from pre- to post-intervention (8 wks)', 'description': 'Subcutaneous fat thickness of the thigh of both legs will be assess using ultrasound techniques'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this project is to improve physical function and muscle health in teenagers and young adults with cerebral palsy (CP) by using an eccentric-overload resistance exercise model\n\nSpecific aims\n\n1. To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in inducing muscle, functional and gait performance adaptations in teenagers with CP.\n2. To increase force, power and muscle mass in the lower limbs of patients with cerebral palsy.\n3. To improve gross motor function, balance and gait through eccentric-overload resistance exercise in teenagers suffering from cerebral palsy.\n\nWe hypothesize that the time-effective flywheel resistance exercise paradigm will result in greater gains in muscle mass and function in teenagers with CP, when compared with conventional weight-stack technology. Importantly, we believe these adaptations will be translated into enhanced gross motor function, balance and gait performance.\n\nForty teenagers and young adults (age range 16-23 yr) with spastic CP will be recruited. They will be randomly assigned to flywheel (FL; n=20) or weight-stack (WS; n=20) resistance exercise. During 8 weeks, all the teenagers will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients will perform either flywheel (FL group) or conventional (WS group) leg press resistance exercise twice per week. Muscle force, power and activity (electromyography; EMG), leg extension lag, co-contraction, balance, functional mobility, gait quality, and muscle and fat thickness of lower extremities are assessed in all patients before and after the 8-week intervention (Fig. 1).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Teenagers and young adults between 16-25 years of age\n* Unilateral or bilateral spastic cerebral palsy\n* Gross Motor Function Classification System (GMFCS) of level I, II or III.\n\nExclusion Criteria\n\n* Surgical treatments of the knee extensor apparatus within the last 12 months\n* Botulinum toxin treatment within the last six months\n* Ongoing intrathecal baclofen treatment'}, 'identificationModule': {'nctId': 'NCT03124628', 'acronym': 'CP-Flywheel', 'briefTitle': 'Effects of Flywheel Exercise on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Effects of Flywheel Resistance Exercise Training on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'Flywheel CP'}, 'secondaryIdInfos': [{'id': '16037', 'type': 'OTHER_GRANT', 'domain': 'Promobilia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flywheel resistance exercise', 'description': 'During 8 weeks, all the subjects will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients in this arm will perform flywheel leg press resistance exercise twice per week.', 'interventionNames': ['Other: Flywheel resistance exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weight-stack resistance exercise', 'description': 'During 8 weeks, all the subjects will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients in this arm will perform conventional, weight-stack leg press resistance exercise twice per week.', 'interventionNames': ['Other: Weight-stack resistance exercise']}], 'interventions': [{'name': 'Flywheel resistance exercise', 'type': 'OTHER', 'otherNames': ['Yo-Yo technology'], 'description': 'Flywheel resistance exercise, originally designed to maintain function, size and quality of skeletal muscle during spaceflight, employs iso-inertial technology rather than gravity dependent weights, which allows for coupled accommodated concentric and eccentric muscle actions, and brief episodes of eccentric overload.', 'armGroupLabels': ['Flywheel resistance exercise']}, {'name': 'Weight-stack resistance exercise', 'type': 'OTHER', 'otherNames': ['Conventional resistance exercise'], 'description': 'Conventional weight-stack resistance exercise', 'armGroupLabels': ['Weight-stack resistance exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17177', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Eva Pontén, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Rodrigo Fernandez Gonzalo', 'investigatorAffiliation': 'Karolinska Institutet'}}}}