N/A
N=14
Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control
To Determine Efficacy of the Headpod · Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT02764775 ↗Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Jan 2019
Primary outcome: Primary: Change in Head Holding Active Time From Baseline to 6 Months — 83.63 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Headpod (Device)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Texas Woman's University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Head Holding Active Time From Baseline to 6 Months |
83.63 | — |
Summary
Inclusion Criteria: children ages 2 to 14 years with poor head control and non progressive diagnoses. Exclusion criteria: significant change of status i.e. prolonged hospitalization, surgery; inability to tolerate using Headpod. Requires use of Headpod 3x per day for minimum of 15 minutes each time over a 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken to document changes.
Eligibility Criteria
Inclusion Criteria
- non progressive diagnoses with poor head control
Exclusion Criteria
- recent prolonged hospitalization; surgery, inability to tolerate wearing the Headpod
Data sourced from ClinicalTrials.gov (NCT02764775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.