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

Not Applicable

Completed

• Conditions: To Determine Efficacy of the Headpod; Cerebral Palsy
• Interventions: Device: Headpod

• Registration Number: NCT02764775
• Lead Sponsor: Texas Woman's University

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2018-05-10
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-09
• Last Update Submitted: 2019-01-09
• Results First Posted: 2019-01-29
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• non progressive diagnoses with poor head control

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Headed utilization	Headpod	Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;

Primary Outcome Measures

Name	Time	Method
Change in Head Holding Active Time From Baseline to 6 Months	baseline to 6 months	Active time in seconds holding head upright

Trial Locations

Locations (1)

TWU School of Physical Therapy; 🇺🇸 Dallas, Texas, United States