Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-01 @ 6:54 AM
Study NCT ID:
NCT00900692
Status:
WITHDRAWN
Last Update Posted:
2013-07-11
First Post:
2009-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Splinting for Excessive Pronation Following CVA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-10', 'studyFirstSubmitDate': '2009-05-12', 'studyFirstSubmitQcDate': '2009-05-12', 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ROM changes with use of treatment', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Excessive pronation', 'CVA', 'Forearm', 'Excessive pronation following CVA'], 'conditions': ['Pronation Contracture']}, 'referencesModule': {'references': [{'pmid': '17270837', 'type': 'BACKGROUND', 'citation': 'Andreasen DS, Aviles AA, Allen SK, Guthrie KB, Jennings BR, Sprigle SH. Exoskeleton for forearm pronation and supination rehabilitation. Conf Proc IEEE Eng Med Biol Soc. 2004;2004:2714-7. doi: 10.1109/IEMBS.2004.1403778.'}, {'pmid': '16263963', 'type': 'BACKGROUND', 'citation': 'Winchester P, McColl R, Querry R, Foreman N, Mosby J, Tansey K, Williamson J. Changes in supraspinal activation patterns following robotic locomotor therapy in motor-incomplete spinal cord injury. Neurorehabil Neural Repair. 2005 Dec;19(4):313-24. doi: 10.1177/1545968305281515.'}, {'type': 'BACKGROUND', 'citation': 'Cooper. Et al. Proceedings of the Stroke Disparities Advisory Panel Meeting, Nov 08, 2002, Bethesda MD, National Institute of Neurological Disorders and Stroke'}, {'pmid': '15201473', 'type': 'BACKGROUND', 'citation': 'McKinley W, Tewksbury MA, Sitter P, Reed J, Floyd S. Assistive technology and computer adaptations for individuals with spinal cord injury. NeuroRehabilitation. 2004;19(2):141-6.'}, {'pmid': '18047458', 'type': 'BACKGROUND', 'citation': 'Horsley SA, Herbert RD, Ada L. Four weeks of daily stretch has little or no effect on wrist contracture after stroke: a randomised controlled trial. Aust J Physiother. 2007;53(4):239-45. doi: 10.1016/s0004-9514(07)70004-1.'}, {'pmid': '9242860', 'type': 'BACKGROUND', 'citation': 'Nuismer BA, Ekes AM, Holm MB. The use of low-load prolonged stretch devices in rehabilitation programs in the Pacific northwest. Am J Occup Ther. 1997 Jul-Aug;51(7):538-43. doi: 10.5014/ajot.51.7.538.'}, {'pmid': '15838530', 'type': 'BACKGROUND', 'citation': 'Bloemen-Vrencken JH, de Witte LP, Post MW. Follow-up care for persons with spinal cord injury living in the community: a systematic review of interventions and their evaluation. Spinal Cord. 2005 Aug;43(8):462-75. doi: 10.1038/sj.sc.3101750.'}, {'pmid': '18047660', 'type': 'BACKGROUND', 'citation': 'Tsao CC, Mirbagheri MM. Upper limb impairments associated with spasticity in neurological disorders. J Neuroeng Rehabil. 2007 Nov 29;4:45. doi: 10.1186/1743-0003-4-45.'}, {'pmid': '15520985', 'type': 'BACKGROUND', 'citation': 'Bryden AM, Kilgore KL, Lind BB, Yu DT. Triceps denervation as a predictor of elbow flexion contractures in C5 and C6 tetraplegia. Arch Phys Med Rehabil. 2004 Nov;85(11):1880-5. doi: 10.1016/j.apmr.2004.01.042.'}, {'pmid': '14682551', 'type': 'BACKGROUND', 'citation': 'Lannin NA, Herbert RD. Is hand splinting effective for adults following stroke? A systematic review and methodologic critique of published research. Clin Rehabil. 2003 Dec;17(8):807-16. doi: 10.1191/0269215503cr682oa.'}, {'pmid': '18554816', 'type': 'BACKGROUND', 'citation': 'Naik AK, Pathirathna S, Jevtovic-Todorovic V. GABAA receptor modulation in dorsal root ganglia in vivo affects chronic pain after nerve injury. Neuroscience. 2008 Jul 17;154(4):1539-53. doi: 10.1016/j.neuroscience.2008.04.061. Epub 2008 May 3.'}, {'pmid': '18542094', 'type': 'BACKGROUND', 'citation': 'Mahmood NS, Kadavigere R, Avinash KR, Rao VR. Magnetic resonance imaging in acute cervical spinal cord injury: a correlative study on spinal cord changes and 1 month motor recovery. Spinal Cord. 2008 Dec;46(12):791-7. doi: 10.1038/sc.2008.55. Epub 2008 Jun 10.'}, {'pmid': '17132119', 'type': 'BACKGROUND', 'citation': 'Harvey L, de Jong I, Goehl G, Mardwedel S. Twelve weeks of nightly stretch does not reduce thumb web-space contractures in people with a neurological condition: a randomised controlled trial. Aust J Physiother. 2006;52(4):251-8. doi: 10.1016/s0004-9514(06)70004-6.'}, {'pmid': '12124669', 'type': 'BACKGROUND', 'citation': 'Patrick JH, Farmer SE, Bromwich W. Muscle stretching for treatment and prevention of contracture in people with spinal cord injury. Spinal Cord. 2002 Aug;40(8):421-2; author reply 423. doi: 10.1038/sj.sc.3101340. No abstract available.'}, {'pmid': '19194671', 'type': 'BACKGROUND', 'citation': 'Lai JM, Francisco GE, Willis FB. Dynamic splinting after treatment with botulinum toxin type-A: a randomized controlled pilot study. Adv Ther. 2009 Feb;26(2):241-8. doi: 10.1007/s12325-008-0139-2. Epub 2009 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine range of motion and lasting effects of Botox injections along with the use of the Supination Dynasplint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients enrolled will have been diagnosed with excessive pronation following a stroke and will display the following symptoms:\n\n* Pronation Contracture\n* Ability to provide consent and follow directions as related to the protocol\n\nExclusion Criteria\n\n* Treatment with Benzodiazepines\n* Treatment with Baclofen (pump or oral)\n* Treatment with Dantrolene sodium\n* Treatment with Tizanidine'}, 'identificationModule': {'nctId': 'NCT00900692', 'acronym': 'SupPro Botox', 'briefTitle': 'Dynamic Splinting for Excessive Pronation Following CVA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dynasplint Systems, Inc.'}, 'officialTitle': 'Dynamic Splinting for Excessive Pronation Following CVA: A Randomized, Controlled Tial', 'orgStudyIdInfo': {'id': '2009.001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dynasplint Group', 'description': 'Along with the standard of care Botox and manual therapy, patients will use the Supination Dynasplint every day', 'interventionNames': ['Device: Dynasplint']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Patients in the standard of care group will have the standard Botox treatments and manual therapy with no additional interventions.'}], 'interventions': [{'name': 'Dynasplint', 'type': 'DEVICE', 'description': 'Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen', 'armGroupLabels': ['Dynasplint Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Rehabilitation Associates of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Marc E Duerden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehabilitation Associates of Indiana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dynasplint Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}