Toe Walker Gait Trial

Gait Clinical Trial

— TW  

Official title:

Dynamic Splinting for Toe Walking: a Randomized, Controlled Study With Gait Analysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01208142
• Other study ID #: 2010.001
• Status: Terminated
• Phase: N/A
• First received: September 22, 2010
• Last updated: August 8, 2013
• Start date: September 2010

Study information

• Verified date: August 2013
• Source: Dynasplint Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the change in ankle plantar flexion while walking, following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as Toe Walkers.

For twelve weeks, patients will either receive the standard treatment or the same standard treatment and the Dynaslint worn at night.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Toe Walking secondary to CP

• 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:

• Acid Maltase Deficiency Myopathy

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gait

Intervention

Other:
• standard of care treatment
weekly standardized physical therapy and daily wear of an AFO

Device:
• Ankle Flexion Dynasplint
Weekly standardized physical therapy, daily wear of an AFO and nightly wear of the ankle flexion Dynasplint

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Dynasplint Systems, Inc.	McMurry University

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

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. — View Citation

Gage JR. Gait analysis in cerebral palsy. London, Mac Keith Press; 1991

Gage JR. The role of gait analysis in the treatment of cerebral palsy. J Pediatr Orthop. 1994 Nov-Dec;14(6):701-2. — View Citation

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. — View Citation

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. — View Citation

Hicks R, Durinick N, Gage JR. Differentiation of idiopathic toe-walking and cerebral palsy. J Pediatr Orthop. 1988 Mar-Apr;8(2):160-3. — View Citation

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)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jan 18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Willis B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26.

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plantar flexion while ambulating	The primary endpoint or dependent variable of this study will be the change in excessive plantar flexion while ambulating. A repeated measures analysis of variance (ANOVA) will be performed to measure kinematic change in gait patterns calculated with an ambulation laboratory test.	12 weeks	No