Toe Walker Gait Trial (TW)

August 8, 2013 updated by: Dynasplint Systems, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
    • Texas
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynasplint Systems, Inc.

Collaborators

McMurry University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 22, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (Estimate)

September 23, 2010

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010.001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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