- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02764775
Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control (headpod)
January 9, 2019 updated by: Julie Brown, Texas Woman's University
Measuring Head Control Changes With 2d Video Analysis After Utilization of the Headpod in Children With Cerebral Palsy and Poor Head Control
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Requires usage of the Headpod 3x per day for a minimum of 15 minutes each time.
Usage required for 6 month period.
Log must be kept documenting usage of the Headpod.
Video will be taken on initial trial use, 1 week post trial use, at 3 months post utilization of the Headpod and at 6 months post utilization of the Headpod.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- TWU School of Physical Therapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- non progressive diagnoses with poor head control
Exclusion Criteria:
- recent prolonged hospitalization; surgery, inability to tolerate wearing the Headpod
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Headed utilization
Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;
|
Adaptive equipment to assist with active head movements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Head Holding Active Time From Baseline to 6 Months
Time Frame: baseline to 6 months
|
Active time in seconds holding head upright
|
baseline to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julie E Brown, DPT, Texas Woman's University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
May 2, 2016
First Submitted That Met QC Criteria
May 5, 2016
First Posted (Estimate)
May 6, 2016
Study Record Updates
Last Update Posted (Actual)
January 29, 2019
Last Update Submitted That Met QC Criteria
January 9, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17641
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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