Toe Walker Gait Trial

N/ATerminatedNCT01208142

Dynasplint Systems, Inc.10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gait

Interventions

standard of care treatmentOTHER

weekly standardized physical therapy and daily wear of an AFO

Ankle Flexion DynasplintDEVICE

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

The Ohio State University Medical Center

Columbus, Ohio, United States

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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