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

NCT ID: NCT02764775

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

To Determine Efficacy of the Headpod; Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Headed utilization

Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;

Group Type: EXPERIMENTAL

Headpod

Intervention Type: DEVICE

Adaptive equipment to assist with active head movements

Interventions

Headpod

Adaptive equipment to assist with active head movements

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• non progressive diagnoses with poor head control

Exclusion Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Woman's University

OTHER

Sponsor Role: lead

Responsible Party

Julie Brown

PT, DPT, PCS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie E Brown, DPT

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Locations

TWU School of Physical Therapy

Dallas, Texas, United States

Countries

United States

Other Identifiers

17641

Identifier Type: -

Identifier Source: org_study_id