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Toe Walker Gait Trial (TW)

This study has been terminated.
(Unrelated to trial)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01208142
First Posted: September 23, 2010
Last Update Posted: August 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
McMurry University
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
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.

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT01208142     History of Changes
Other Study ID Numbers: 2010.001
First Submitted: September 22, 2010
First Posted: September 23, 2010
Last Update Posted: August 12, 2013
Last Verified: August 2013

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