Toe Walker Gait Trial

Not Applicable

Terminated

• Conditions: Gait
• Interventions: Other: standard of care treatment; Device: Ankle Flexion Dynasplint

• Registration Number: NCT01208142
• Lead Sponsor: Dynasplint Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12
• Primary Completion: 2016-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	standard of care treatment	25 Control subjects will only receive SOC (a weekly standardized physical therapy and daily wear of an AFO).
Dynasplint	Ankle Flexion Dynasplint	25 Patients will receive the standard of care as well as an Ankle Flexion Dynasplint

Primary Outcome Measures

Name	Time	Method
Change in plantar flexion while ambulating	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.

Trial Locations

Locations (2)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States