Toe Walker Gait Trial (TW)
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dynamic Splinting for Toe Walking: a Randomized, Controlled Study With Gait Analysis|
- Change in plantar flexion while ambulating [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208142
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|Texas Tech University Health Sciences Center|
|Lubbock, Texas, United States, 79430|