Trial Outcomes & Findings for Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control (NCT NCT02764775)

Last Updated: 2019-01-29

Results Overview

Active time in seconds holding head upright

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

baseline to 6 months

Results posted on

2019-01-29

Participant milestones
Measure	Headpod Utilization Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time. Three measurements were taken: Prior to Headpod use, after 3 months of Headpod use and, after 6 months of Headpod use. Headpod: Adaptive equipment to assist with active head movements
Overall Study STARTED	14
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	Headpod Utilization Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time. Three measurements were taken: Prior to Headpod use, after 3 months of Headpod use and, after 6 months of Headpod use. Headpod: Adaptive equipment to assist with active head movements
Overall Study Death	1
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	3

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Headpod Utilization n=14 Participants Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time; Headpod: Adaptive equipment to assist with active head movements
Age, Categorical <=18 years	14 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=14 Participants
Age, Categorical >=65 years	0 Participants n=14 Participants
Age, Continuous	7 years n=14 Participants
Sex: Female, Male Female	8 Participants n=14 Participants
Sex: Female, Male Male	6 Participants n=14 Participants
Region of Enrollment United States	14 Participants n=14 Participants
Active head time	190.33 seconds STANDARD_DEVIATION 42.31 • n=14 Participants

Timeframe: baseline to 6 months

Population: Children ages 3 to 11 years

Active time in seconds holding head upright

Outcome measures
Measure	Headpod Utilization n=14 Participants Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time. Three measurements were taken: Prior to Headpod use, after 3 months of Headpod use and, after 6 months of Headpod use. Headpod: Adaptive equipment to assist with active head movements
Change in Head Holding Active Time From Baseline to 6 Months	83.63 Seconds Standard Deviation 38.07

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events
Measure	Headed Utilization n=14 participants at risk Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time; Headpod: Adaptive equipment to assist with active head movements
General disorders Death unrelated to participation in study	7.1% 1/14 • Number of events 1 • 1 year, 6 months All cause mortality: One child unexpectedly died 2 months into the study. The death was unrelated to Headpod use.

Adverse event data not reported

Fort Worth Independent School district

Phone: 214-725-8232