Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control

Cerebral Palsy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764775
• Other study ID #: 17641
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2019
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

Inclusion Criteria:

• non progressive diagnoses with poor head control

Exclusion Criteria:

• recent prolonged hospitalization; surgery, inability to tolerate wearing the Headpod

Related Conditions & MeSH terms

• Cerebral Palsy
• To Determine Efficacy of the Headpod

Intervention

Device:
• Headpod
Adaptive equipment to assist with active head movements

Locations

Country	Name	City	State
United States	TWU School of Physical Therapy	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Head Holding Active Time From Baseline to 6 Months	Active time in seconds holding head upright	baseline to 6 months