NCT01208142

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

6 years

First QC Date

September 22, 2010

Last Update Submit

August 8, 2013

Conditions

Gait

Keywords

toe walkerPediatric toe walkingankle flexion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

25 Control subjects will only receive SOC (a weekly standardized physical therapy and daily wear of an AFO).

Other: standard of care treatment

Dynasplint

EXPERIMENTAL

25 Patients will receive the standard of care as well as an Ankle Flexion Dynasplint

Device: Ankle Flexion Dynasplint

Interventions

standard of care treatmentOTHER

weekly standardized physical therapy and daily wear of an AFO

Standard of care
Ankle Flexion DynasplintDEVICE

Weekly standardized physical therapy, daily wear of an AFO and nightly wear of the ankle flexion Dynasplint

Dynasplint

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (17)

  • 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.

    PMID: 19946498BACKGROUND

  • 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.

    PMID: 17057457BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 16413188BACKGROUND

  • 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.

    PMID: 10739286BACKGROUND

  • 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.

    PMID: 16508533BACKGROUND

  • 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.

    PMID: 17979859BACKGROUND

  • 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.

    PMID: 7814578BACKGROUND

  • 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.

    PMID: 11809577BACKGROUND

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

    PMID: 3350949BACKGROUND

  • 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.

    PMID: 11853322BACKGROUND

  • 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.

    PMID: 11087280BACKGROUND

  • 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.

    PMID: 16670545BACKGROUND

  • 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.

    PMID: 11675554BACKGROUND

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

    BACKGROUND

  • 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)

    BACKGROUND

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

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2010

First Posted

September 23, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2016

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

US(2)