Toe Walker Gait Trial (TW)

This study has been terminated.
(Unrelated to trial)
Sponsor:
Collaborator:
McMurry University
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01208142
First received: September 22, 2010
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Gait
Other: standard of care treatment
Device: Ankle Flexion Dynasplint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynamic Splinting for Toe Walking: a Randomized, Controlled Study With Gait Analysis

Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:
  • Change in plantar flexion while ambulating [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: September 2010
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of care
25 Control subjects will only receive SOC (a weekly standardized physical therapy and daily wear of an AFO).
Other: standard of care treatment
weekly standardized physical therapy and daily wear of an AFO
Experimental: Dynasplint
25 Patients will receive the standard of care as well as an Ankle Flexion Dynasplint
Device: Ankle Flexion Dynasplint
Weekly standardized physical therapy, daily wear of an AFO and nightly wear of the ankle flexion Dynasplint

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208142

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Dynasplint Systems, Inc.
McMurry University
  More Information

Publications:
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.
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.

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT01208142     History of Changes
Other Study ID Numbers: 2010.001
Study First Received: September 22, 2010
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dynasplint Systems, Inc.:
toe walker
Pediatric toe walking
ankle flexion

ClinicalTrials.gov processed this record on October 20, 2014