Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2010-09-30
Brief Summary
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For twelve weeks, patients will either receive the standard treatment or the same standard treatment and the Dynaslint worn at night.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of care
25 Control subjects will only receive SOC (a weekly standardized physical therapy and daily wear of an AFO).
standard of care treatment
weekly standardized physical therapy and daily wear of an AFO
Dynasplint
25 Patients will receive the standard of care as well as an Ankle Flexion Dynasplint
Ankle Flexion Dynasplint
Weekly standardized physical therapy, daily wear of an AFO and nightly wear of the ankle flexion Dynasplint
Interventions
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standard of care treatment
weekly standardized physical therapy and daily wear of an AFO
Ankle Flexion Dynasplint
Weekly standardized physical therapy, daily wear of an AFO and nightly wear of the ankle flexion Dynasplint
Eligibility Criteria
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Inclusion Criteria
* Idiopathic TW
* Inability to ambulate with initial heel-contact
* Inability to bear weight and stand flat-footed for over one minute
* Inability to stand or hop on one foot (symptomatic) for more than one minute
Exclusion Criteria
* Acute Paralytic Poliomyelitis
* Spinal Muscular Atrophy-all types
* Stroke, ischemic or hemorrhagic, all types
* Multiple Sclerosis
* Traumatic Brain Injury (including Shaken Baby Syndrome)
* Unilateral ROM deficits in Knee or Hip
* Previous Achilles Tendon lengthening surgery
* Hemiplegic Cerebral Palsy
* Muscular Dystrophy-all types
1 Year
18 Years
ALL
No
Sponsors
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McMurry University
OTHER
Dynasplint Systems, Inc.
INDUSTRY
Responsible Party
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Locations
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The Ohio State University Medical Center
Columbus, Ohio, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Countries
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References
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Lundequam P, Willis FB. Dynamic splinting home therapy for toe walking: a case report. Cases J. 2009 Nov 10;2:188. doi: 10.1186/1757-1626-2-188.
Booth MY, Yates CC, Edgar TS, Bandy WD. Serial casting vs combined intervention with botulinum toxin A and serial casting in the treatment of spastic equinus in children. Pediatr Phys Ther. 2003 Winter;15(4):216-20. doi: 10.1097/01.PEP.0000096382.65499.E2.
Li S, Bishop M, Sensac C. The Effect of Botulinium Toxin Type A Combined with Physical therapy on Gait in Children with idiopathic Toe Walking. Pediatric Physical Therapy. 2004 16(1):59.
Romkes J, Hell AK, Brunner R. Changes in muscle activity in children with hemiplegic cerebral palsy while walking with and without ankle-foot orthoses. Gait Posture. 2006 Dec;24(4):467-74. doi: 10.1016/j.gaitpost.2005.12.001. Epub 2006 Jan 18.
Brouwer B, Davidson LK, Olney SJ. Serial casting in idiopathic toe-walkers and children with spastic cerebral palsy. J Pediatr Orthop. 2000 Mar-Apr;20(2):221-5.
Mulligan H, Wilmshurst E. Physiotherapy assessment and treatment for an ambulant child with cerebral palsy after botox A to the lower limbs: a case report. Pediatr Phys Ther. 2006 Spring;18(1):39-48. doi: 10.1097/01.pep.0000202252.92562.4c.
Willis AW, Crowner B, Brunstrom JE, Kissel A, Racette BA. High dose botulinum toxin A for the treatment of lower extremity hypertonicity in children with cerebral palsy. Dev Med Child Neurol. 2007 Nov;49(11):818-22. doi: 10.1111/j.1469-8749.2007.00818.x.
Gage JR. The role of gait analysis in the treatment of cerebral palsy. J Pediatr Orthop. 1994 Nov-Dec;14(6):701-2. No abstract available.
Romkes J, Brunner R. Comparison of a dynamic and a hinged ankle-foot orthosis by gait analysis in patients with hemiplegic cerebral palsy. Gait Posture. 2002 Feb;15(1):18-24. doi: 10.1016/s0966-6362(01)00178-3.
Hicks R, Durinick N, Gage JR. Differentiation of idiopathic toe-walking and cerebral palsy. J Pediatr Orthop. 1988 Mar-Apr;8(2):160-3.
Galli M, Crivellini M, Santambrogio GC, Fazzi E, Motta F. Short-term effects of "botulinum toxin a" as treatment for children with cerebral palsy: kinematic and kinetic aspects at the ankle joint. Funct Neurol. 2001 Oct-Dec;16(4):317-23.
Ubhi T, Bhakta BB, Ives HL, Allgar V, Roussounis SH. Randomised double blind placebo controlled trial of the effect of botulinum toxin on walking in cerebral palsy. Arch Dis Child. 2000 Dec;83(6):481-7. doi: 10.1136/adc.83.6.481.
Hemo Y, Macdessi SJ, Pierce RA, Aiona MD, Sussman MD. Outcome of patients after Achilles tendon lengthening for treatment of idiopathic toe walking. J Pediatr Orthop. 2006 May-Jun;26(3):336-40. doi: 10.1097/01.bpo.0000217743.44609.44.
Weigl D, Copeliovitch L, Itzchak Y, Strauss S. Sonographic healing stages of Achilles tendon after tenomuscular lengthening in children with cerebral palsy. J Pediatr Orthop. 2001 Nov-Dec;21(6):778-83.
Gage JR. Gait analysis in cerebral palsy. London, Mac Keith Press; 1991
Lai J, Jones M, Willis B. Efficacy of Dynasplint Splinting on PlantarflexionTone and Contracture Seen in CVA and TBI Subject: A Controlled Cross-Over Study. Arch Phys Med Rehabil. 2007 Oct;88(10)
Willis B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26.
Other Identifiers
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2010.001
Identifier Type: -
Identifier Source: org_study_id