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Toe Walker Gait Trial

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01208142
Acronym
TW
Enrollment
10
Registered
2010-09-23
Start date
2010-09-30
Completion date
Unknown
Last updated
2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait

Keywords

toe walker, Pediatric toe walking, ankle flexion

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.

Interventions

OTHERstandard of care treatment

weekly standardized physical therapy and daily wear of an AFO

DEVICEAnkle Flexion Dynasplint

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

Sponsors

McMurry University
CollaboratorOTHER
Dynasplint Systems, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in plantar flexion while ambulating12 weeksThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026