Clinical trial NCT01208142: Toe Walker Gait Trial
Official title: Dynamic Splinting for Toe Walking: a Randomized, Controlled Study With Gait Analysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gait
Keywords: toe walker
Pediatric toe walking
ankle flexion
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: McMurry University
First posted: 2010-09-23
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in plantar flexion while ambulating
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
References:
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