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

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Texas Woman's University

Status

Completed

Conditions

To Determine Efficacy of the Headpod
Cerebral Palsy

Treatments

Device: Headpod

Study type

Interventional

Funder types

Other

Identifiers

NCT02764775
17641

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

2 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

non progressive diagnoses with poor head control

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Headed utilization
Experimental group
Description:
Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;
Treatment:
Device: Headpod

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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