Back to resultsMeasuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control (headpod)
Primary Purpose
To Determine Efficacy of the Headpod, Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Headpod
Sponsored by
About this trial
This is an interventional treatment trial for To Determine Efficacy of the Headpod
Eligibility Criteria
Inclusion Criteria:
- non progressive diagnoses with poor head control
Exclusion Criteria:
- recent prolonged hospitalization; surgery, inability to tolerate wearing the Headpod
Sites / Locations
- TWU School of Physical Therapy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Headed utilization
Arm Description
Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;
Outcomes
Primary Outcome Measures
Change in Head Holding Active Time From Baseline to 6 Months
Active time in seconds holding head upright
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02764775
Brief Title
Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control
Acronym
headpod
Official Title
Measuring Head Control Changes With 2d Video Analysis After Utilization of the Headpod in Children With Cerebral Palsy and Poor Head Control
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Determine Efficacy of the Headpod, Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi-experimental, one-way repeated measures design
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Headed utilization
Arm Type
Experimental
Arm Description
Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;
Intervention Type
Device
Intervention Name(s)
Headpod
Intervention Description
Adaptive equipment to assist with active head movements
Primary Outcome Measure Information:
Title
Change in Head Holding Active Time From Baseline to 6 Months
Description
Active time in seconds holding head upright
Time Frame
baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non progressive diagnoses with poor head control
Exclusion Criteria:
recent prolonged hospitalization; surgery, inability to tolerate wearing the Headpod
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie E Brown, DPT
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
TWU School of Physical Therapy
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control
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