Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT01329705
Status:
WITHDRAWN
Last Update Posted:
2013-08-12
First Post:
2011-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dynamic Splinting for Plantarflexion in Spastic Hemiplegia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-08', 'studyFirstSubmitDate': '2011-04-04', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gait pattern', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spastic Hemiplegia']}, 'referencesModule': {'references': [{'pmid': '19561389', 'type': 'BACKGROUND', 'citation': 'Abe H, Michimata A, Sugawara K, Sugaya N, Izumi S. Improving gait stability in stroke hemiplegic patients with a plastic ankle-foot orthosis. Tohoku J Exp Med. 2009 Jul;218(3):193-9. doi: 10.1620/tjem.218.193.'}, {'pmid': '14992678', 'type': 'BACKGROUND', 'citation': 'Cormack J, Powers CM. Is there evidence that botulinum toxin injections are more effective than phenol injections in relieving poststroke reflex activity during plantar flexion, thereby increasing ankle range of motion and improving gait function? Phys Ther. 2004 Jan;84(1):76-84. No abstract available.'}, {'pmid': '19570678', 'type': 'BACKGROUND', 'citation': 'Cruz TH, Dhaher YY. Impact of ankle-foot-orthosis on frontal plane behaviors post-stroke. Gait Posture. 2009 Oct;30(3):312-6. doi: 10.1016/j.gaitpost.2009.05.018. Epub 2009 Jun 30.'}, {'pmid': '19556526', 'type': 'BACKGROUND', 'citation': 'Franceschini M, Carda S, Agosti M, Antenucci R, Malgrati D, Cisari C; Gruppo Italiano Studio Allevio Carico Ictus. Walking after stroke: what does treadmill training with body weight support add to overground gait training in patients early after stroke?: a single-blind, randomized, controlled trial. Stroke. 2009 Sep;40(9):3079-85. doi: 10.1161/STROKEAHA.109.555540. Epub 2009 Jun 25.'}, {'pmid': '19774307', 'type': 'BACKGROUND', 'citation': 'Freivogel S, Schmalohr D, Mehrholz J. Improved walking ability and reduced therapeutic stress with an electromechanical gait device. J Rehabil Med. 2009 Sep;41(9):734-9. doi: 10.2340/16501977-0422.'}, {'pmid': '15179643', 'type': 'BACKGROUND', 'citation': 'Johnson CA, Burridge JH, Strike PW, Wood DE, Swain ID. The effect of combined use of botulinum toxin type A and functional electric stimulation in the treatment of spastic drop foot after stroke: a preliminary investigation. Arch Phys Med Rehabil. 2004 Jun;85(6):902-9. doi: 10.1016/j.apmr.2003.08.081.'}, {'pmid': '19834018', 'type': 'BACKGROUND', 'citation': 'Kesar TM, Perumal R, Reisman DS, Jancosko A, Rudolph KS, Higginson JS, Binder-Macleod SA. Functional electrical stimulation of ankle plantarflexor and dorsiflexor muscles: effects on poststroke gait. Stroke. 2009 Dec;40(12):3821-7. doi: 10.1161/STROKEAHA.109.560375. Epub 2009 Oct 15.'}, {'pmid': '19692788', 'type': 'BACKGROUND', 'citation': 'Kim JH, Jang SH, Kim CS, Jung JH, You JH. Use of virtual reality to enhance balance and ambulation in chronic stroke: a double-blind, randomized controlled study. Am J Phys Med Rehabil. 2009 Sep;88(9):693-701. doi: 10.1097/PHM.0b013e3181b33350.'}, {'pmid': '19809391', 'type': 'BACKGROUND', 'citation': 'Lam T, Luttmann K, Houldin A, Chan C. Treadmill-based locomotor training with leg weights to enhance functional ambulation in people with chronic stroke: a pilot study. J Neurol Phys Ther. 2009 Sep;33(3):129-35. doi: 10.1097/NPT.0b013e3181b57de5.'}, {'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.'}, {'pmid': '19605933', 'type': 'BACKGROUND', 'citation': "John MM, Willis FB, Portillo A. Dynamic splinting for runner's toe: a case report with gait analysis. J Am Podiatr Med Assoc. 2009 Jul-Aug;99(4):367-70. doi: 10.7547/0980367."}, {'pmid': '16702088', 'type': 'BACKGROUND', 'citation': 'Masiero S, Briani C, Marchese-Ragona R, Giacometti P, Costantini M, Zaninotto G. Successful treatment of long-standing post-stroke dysphagia with botulinum toxin and rehabilitation. J Rehabil Med. 2006 May;38(3):201-3. doi: 10.1080/16501970500515840.'}, {'pmid': '14523751', 'type': 'BACKGROUND', 'citation': 'McGuire JR. Effective use of chemodenervation and chemical neurolysis in the management of poststroke spasticity. Top Stroke Rehabil. 2001 Spring;8(1):47-55. doi: 10.1310/CYP4-BPXC-CG8M-XCA3.'}, {'pmid': '19581199', 'type': 'BACKGROUND', 'citation': 'Michael K, Goldberg AP, Treuth MS, Beans J, Normandt P, Macko RF. Progressive adaptive physical activity in stroke improves balance, gait, and fitness: preliminary results. Top Stroke Rehabil. 2009 Mar-Apr;16(2):133-9. doi: 10.1310/tsr1602-133.'}, {'pmid': '20821903', 'type': 'BACKGROUND', 'citation': 'Pleis JR, Lucas JW, Ward BW. Summary health statistics for U.S. adults: National Health Interview Survey, 2008. Vital Health Stat 10. 2009 Dec;(242):1-157.'}, {'pmid': '19588381', 'type': 'BACKGROUND', 'citation': 'States RA, Pappas E, Salem Y. Overground physical therapy gait training for chronic stroke patients with mobility deficits. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD006075. doi: 10.1002/14651858.CD006075.pub2.'}, {'pmid': '19561034', 'type': 'BACKGROUND', 'citation': 'Stock R, Mork PJ. The effect of an intensive exercise programme on leg function in chronic stroke patients: a pilot study with one-year follow-up. Clin Rehabil. 2009 Sep;23(9):790-9. doi: 10.1177/0269215509335291. Epub 2009 Jun 26.'}, {'pmid': '17224840', 'type': 'BACKGROUND', 'citation': 'Usuba M, Akai M, Shirasaki Y, Miyakawa S. Experimental joint contracture correction with low torque--long duration repeated stretching. Clin Orthop Relat Res. 2007 Mar;456:70-8. doi: 10.1097/BLO.0b013e31803212bf.'}, {'type': 'BACKGROUND', 'citation': 'Willis, F. B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26.'}, {'type': 'BACKGROUND', 'citation': 'Lai JM, Jones M, and Willis FB. Effect of Dynamic Splinting on Excessive Plantarflexion Tone/Contracture: A Controlled, Crossover Study. Proceedings of the 16th European Congress of Physical and Rehabilitation Medicine. Minerva Medica pubs, Italy, August 2008, pg 106-109.'}, {'pmid': '20813995', 'type': 'BACKGROUND', 'citation': 'Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.'}, {'pmid': '19171871', 'type': 'BACKGROUND', 'citation': "Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):480-6. doi: 10.1161/CIRCULATIONAHA.108.191259. No abstract available."}, {'type': 'BACKGROUND', 'citation': 'Sheean G. Neurophysiology of spasticity. In: Barnes MP, Johnson GR. Upper motor neuron syndrome and spasticity. Cambridge University Press, 2008: 9-63.'}, {'pmid': '7964805', 'type': 'BACKGROUND', 'citation': 'Hesse S, Lucke D, Malezic M, Bertelt C, Friedrich H, Gregoric M, Mauritz KH. Botulinum toxin treatment for lower limb extensor spasticity in chronic hemiparetic patients. J Neurol Neurosurg Psychiatry. 1994 Nov;57(11):1321-4. doi: 10.1136/jnnp.57.11.1321.'}, {'pmid': '12686794', 'type': 'BACKGROUND', 'citation': 'Pittock SJ, Moore AP, Hardiman O, Ehler E, Kovac M, Bojakowski J, Al Khawaja I, Brozman M, Kanovsky P, Skorometz A, Slawek J, Reichel G, Stenner A, Timerbaeva S, Stelmasiak Z, Zifko UA, Bhakta B, Coxon E. A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis. 2003;15(4):289-300. doi: 10.1159/000069495.'}, {'pmid': '11992980', 'type': 'BACKGROUND', 'citation': 'Harvey L, Herbert R, Crosbie J. Does stretching induce lasting increases in joint ROM? A systematic review. Physiother Res Int. 2002;7(1):1-13. doi: 10.1002/pri.236.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX) injections (tone management) and dynamic splinting (contracture reduction) for improving gait patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and resultant excessive plantarflexion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients enrolled will be male or female, be at least 18 years of age, and have been diagnosed with spastic hemiplegia and excessive plantarflexion, which includes the following:\n\n 1. Diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study\n 2. Reduced AROM and PROM in ankle dorsiflexion\n 3. Ability to ambulate safely 20 feet without an ankle-foot orthosis (AFO)\n 4. Inability to ambulate with initial heel-contact\n 5. No prior BTX treatment within 6 months\n 6. R1 of -10° or greater (using the Tardeiu method of assessment)\n 7. Mean Ashworth Scale Test ≥3 for plantarflexors\n\nExclusion Criteria:\n\n1. Bell's Palsy\n2. Viral Encephalitis\n3. Muscular Dystrophy\n4. Multiple Sclerosis\n5. Prior heel-cord lengthening or tendon-transfer procedure in the foot/ankle\n6. Subjects with a fixed contracture of the ankle\n7. Female subjects who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or are of childbearing potential and do not practice a reliable method of birth control\n8. Bleeding disorders\n9. Diagnosis of a disease that may interfere with neuromuscular function (ie. Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, amyotrophic lateral sclerosis)\n10. Subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function\n11. Subjects with profound weakness or atrophy of the muscles in the target areas of injection\n12. Active systemic infection or infection at the injection site\n13. Allergy or sensitivity to botulinum toxin A"}, 'identificationModule': {'nctId': 'NCT01329705', 'briefTitle': 'Dynamic Splinting for Plantarflexion in Spastic Hemiplegia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dynasplint Systems, Inc.'}, 'officialTitle': 'Dynamic Splinting for Excessive Plantarflexion in Patients With Spastic Hemiplegia: A Randomized, Controlled Study of Gait Analysis', 'orgStudyIdInfo': {'id': 'Dyna-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'All patients will be treated with the current standard of care including onabotulinum toxin', 'interventionNames': ['Other: Standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'Dynasplint', 'description': 'Patients in the experimental Dynasplint group will be treated with the current standard of care, including onabotulinum toxin, and use the Ankle Dorsiflexion Dynasplint', 'interventionNames': ['Device: Ankle Dorsiflexion Dynasplint']}], 'interventions': [{'name': 'Ankle Dorsiflexion Dynasplint', 'type': 'DEVICE', 'otherNames': ['ADFD, AFD'], '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']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'Patients will begin a 12 week course of physical therapy with once-weekly therapy appointment, focusing on:\n\n* range of motion stretching of the Achilles tendon, hamstrings, hip flexors and any other tight musculature\n* strengthening of tibialis anterior to allow dorsiflexion in swing phase of gait as well as strengthening of other weak musculature\n* gait training to improve heel strike and toe off, stride length, and gait progression\n* sensory, proprioceptive training in foot position and degree of plantarflexion or dorsiflexion\n* no electric stimulation (e-stim) will be utilized', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dynasplint Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}