Cerebral PalsyNCT02242994
Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy
A study testing Dynavox Maestro and Experimental App in people with Cerebral Palsy, run by Axel Krieger at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a touch screen application designed to help pediatric patients with cerebral palsy communicate. The study will test how well patients type on two different tools: one tool is already on the market , and the second tool is a newly developed App. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Dynavox Maestro and Experimental App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Aug 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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between the ages of 7 years old - 21 years old
- been diagnosed with spastic or dystonic diplegic or quadriplegic cerebral palsy.
- are able to communicate through written words
- are able to follow a 3- steps directions, and follow study directions and procedures.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National
Washington D.C., District of Columbia, 20010
About this study
The purpose of this study is to evaluate a touch screen application designed to help pediatric patients with cerebral palsy communicate. The study will test how well patients type on two different tools: one tool is already on the market , and the second tool is a newly developed App.
- Conditions
- Cerebral Palsy
- Being tested
- Dynavox Maestro, Experimental App
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynavox MaestroDevice
Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
Experimental AppDevice
Participant receives experimental app to test speed and error rate of communication.
| Study group | Role | What they receive |
|---|---|---|
| Dynavox Maestro and Experimental App | Experimental | Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned. Receives: Device: Dynavox Maestro; Device: Experimental App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of Communication
Measure time (in minutes) to type 3 pre-set sentences
Measured: Immediately
Secondary outcomes (1)
Error Rate of Communication
Amount of typing errors per sentence
Measured: At time of experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionAug 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 Cerebral PalsyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axel Krieger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Axel Krieger, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242994
- Sponsor's protocol ID
- Pro00003767
- Status last verified
- Oct 2016
- First submitted
- 24 Jul 2014
- Last updated
- 14 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02242994
- Acronym / sponsor ID
- Pro00003767
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Axel KriegerUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Posted 14 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate a touch screen application designed to help pediatric patients with cerebral palsy communicate. The study will test how well patients type on two different tools: one tool is already on the market , and the second tool is a newly developed App.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynavox Maestro and Experimental App | Experimental | Device: Dynavox Maestro, Device: Experimental AppReceives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients between the ages of 7 years old - 21 years old
- been diagnosed with spastic or dystonic diplegic or quadriplegic cerebral palsy.
- are able to communicate through written words
- are able to follow a 3- steps directions, and follow study directions and procedures.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Dynavox MaestroReceives commercially available communication device Dynavox Maestro to test speed and quality of communication. | Device | Dynavox Maestro and Experimental App |
| Experimental AppParticipant receives experimental app to test speed and error rate of communication. | Device | Dynavox Maestro and Experimental App |
Primary outcome
Speed of Communication
Time frame: Immediately
Measure time (in minutes) to type 3 pre-set sentences
1 secondary outcome
Error Rate of Communication
Time frame: At time of experiment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynavox Maestro and Experimental App in people with Cerebral Palsy, run by Axel Krieger 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 4 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 14 Dec 2016. 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 14 Dec 2016). 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?
Speed of Communication (time frame: Immediately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2016.