Toe Walker Gait Trial (TW)
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|ClinicalTrials.gov Identifier: NCT01208142|
Recruitment Status : Terminated (Unrelated to trial)
First Posted : September 23, 2010
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Gait||Other: standard of care treatment Device: Ankle Flexion Dynasplint||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dynamic Splinting for Toe Walking: a Randomized, Controlled Study With Gait Analysis|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||September 2016|
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
- Change in plantar flexion while ambulating [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|