To Determine Efficacy of the HeadpodheadpodNCT02764775

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

A study testing Headpod in people with To Determine Efficacy of the Headpod and Cerebral Palsy, run by Texas Woman's University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 14 years
Conditions the study is for: To Determine Efficacy of the Headpod, Cerebral Palsy
What is being tested?: Headpod
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

non progressive diagnoses with poor head control

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

TWU School of Physical Therapy
Dallas, Texas, 75235

Other trials in United States

About this study

Official title: Measuring Head Control Changes With 2d Video Analysis After Utilization of the Headpod in Children With Cerebral Palsy and Poor Head Control

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.

Read the 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
Being tested: Headpod
Medical subject headings: Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HeadpodDevice
Adaptive equipment to assist with active head movements

Study groups in NCT02764775
Study group	Role	What they receive
Headed utilization	Experimental	Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time; Receives: Device: Headpod

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Dec 2016

First posted6 May 2016 (estimated)
Study startMar 2016
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for To Determine Efficacy of the HeadpodStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Quasi-experimental, one-way repeated measures design
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02764775
Sponsor's protocol ID: 17641
Acronym: headpod
Status last verified: Jan 2019
First submitted: 2 May 2016
Last updated: 29 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measuring Head Control Changes With 2d Video Analysis After Utilization of the Headpod in Children With Cerebral Palsy and Poor Head Control
ClinicalTrials.gov ID: NCT02764775
Acronym / sponsor ID: headpod / 17641
Conditions: To Determine Efficacy of the Headpod, Cerebral Palsy
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Texas Woman's UniversityUniversity, hospital or other
Study start: Mar 2016 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 6 May 2016 (estimated)
Results: Posted 29 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Quasi-experimental, one-way repeated measures design

Arm	Type	Receives
Headed utilization	Experimental	Device: HeadpodUse of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;

Who may qualify

Ages: 2 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

non progressive diagnoses with poor head control

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HeadpodAdaptive equipment to assist with active head movements	Device	Headed utilization

Primary outcome

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

Results and safety

Results posted to the registry on 29 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Headpod Utilization	14	8

Primary outcome: Change in Head Holding Active Time From Baseline to 6 Months

Time frame: baseline to 6 months. Mean (Standard Deviation). Unit: Seconds

Measure	Headpod Utilization n = 14
Value	83.63 (38.07)

Population analysed: Children ages 3 to 11 years

Adverse events

Time frame: 1 year, 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Headed Utilization	1 of 14 (7.1%)	0 of 14 (0%)	1 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julie E Brown, DPT principal investigator

Texas Woman's University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Headpod in people with To Determine Efficacy of the Headpod and Cerebral Palsy, run by Texas Woman's University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Head Holding Active Time From Baseline to 6 Months (time frame: baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02764775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.