Cerebral PalsyYouGrabberNCT02368223
Feasibility of the Portable YouGrabber System
A study testing YouGrabber in people with Cerebral Palsy and Stroke, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The aim of the study is to determine the feasibility of the portable version of the YouGrabber® system in children with central motor disorders. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Stroke, Traumatic Brain Injury
- What is being tested?
- YouGrabber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Central motor disorders
- Ability to sit in an upright position for 45 minutes
Who cannot join
- Manual Ability Classification Scale (MACS) V
- Severe visual or auditory impairments
- Severe photosensitive epilepsy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis
Affoltern am Albis, CH-8910
About this study
Official title: Feasibility of a Home-based Interactive System for Upper Limb Therapy (YouGrabber)
The aim of the study is to determine the feasibility of the portable version of the YouGrabber® system in children with central motor disorders.
Read the detailed description
In a feasibility trial with the portable version of the YouGrabber® system it will be determined if the technique and equipment are ready to be used in a home setting where children with central motor disorders train with assistance of caregivers but without a therapist. Furthermore, it will be examined if children and adolescents with central motor disorders accept this home-based system and if they are motivated for using it.
- Conditions
- Cerebral Palsy, Stroke, Traumatic Brain Injury, Meningomyelocele, Central Nervous System Diseases
- Being tested
- YouGrabber
- Keywords
- Children, Rehabilitation, Telerehabilitation, Upper limb therapy
- Medical subject headings
- Cerebral Palsy, Stroke, Brain Injuries, Traumatic, Meningomyelocele, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YouGrabberDevice
2 weeks of home-based therapy with a virtual-reality enhanced upper limb training system
| Study group | Role | What they receive |
|---|---|---|
| YouGrabber training | Experimental | Home-based YouGrabber training Receives: Device: YouGrabber |
What is being measured
The primary outcome is the main question the study is designed to answer.
User satisfaction (Questionnaire about usability, motivation, general opinion)
Questionnaire about usability, motivation, general opinion
Measured: week 2
Secondary outcomes (2)
Device usage (Total time of exercise per week; time of training session)
Total time of exercise per week; time of training session
Measured: week 2
Error rate (Error prone games; application problems as a home-based system)
Error prone games; application problems as a home-based system
Measured: week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinna Gerber, MSc, Principal investigator, University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368223
- Sponsor's protocol ID
- YouGrabber_Feasibility_2014
- Acronym
- YouGrabber
- Status last verified
- Jul 2015
- First submitted
- 13 Feb 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerber CN, Kunz B, van Hedel HJ. Preparing a neuropediatric upper limb exergame rehabilitation system for home-use: a feasibility study. J Neuroeng Rehabil. 2016 Mar 23;13:33. doi: 10.1186/s12984-016-0141-x.
PubMed 27008504
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Home-based Interactive System for Upper Limb Therapy (YouGrabber)
- ClinicalTrials.gov ID
- NCT02368223
- Acronym / sponsor ID
- YouGrabber / YouGrabber_Feasibility_2014
- Conditions
- Cerebral Palsy, Stroke, Traumatic Brain Injury, Meningomyelocele, Central Nervous System Diseases
- Keywords
- Children, Rehabilitation, Telerehabilitation, Upper limb therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determine the feasibility of the portable version of the YouGrabber® system in children with central motor disorders.
Detailed description
In a feasibility trial with the portable version of the YouGrabber® system it will be determined if the technique and equipment are ready to be used in a home setting where children with central motor disorders train with assistance of caregivers but without a therapist. Furthermore, it will be examined if children and adolescents with central motor disorders accept this home-based system and if they are motivated for using it.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YouGrabber training | Experimental | Device: YouGrabberHome-based YouGrabber training |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Central motor disorders
- Ability to sit in an upright position for 45 minutes
Key exclusion criteria (3 listed)
- Manual Ability Classification Scale (MACS) V
- Severe visual or auditory impairments
- Severe photosensitive epilepsy
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 |
|---|---|---|
| YouGrabber2 weeks of home-based therapy with a virtual-reality enhanced upper limb training system | Device | YouGrabber training |
Primary outcome
User satisfaction (Questionnaire about usability, motivation, general opinion)
Time frame: week 2
Questionnaire about usability, motivation, general opinion
2 secondary outcomes
Device usage (Total time of exercise per week; time of training session)
Time frame: week 2
Error rate (Error prone games; application problems as a home-based system)
Time frame: week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Derived from this study: PubMed 27008504Gerber CN, Kunz B, van Hedel HJ. Preparing a neuropediatric upper limb exergame rehabilitation system for home-use: a feasibility study. J Neuroeng Rehabil. 2016 Mar 23;13:33. doi: 10.1186/s12984-016-0141-x.
- Research Projects of the Pediatric Rehab Research Group at the rehabilitation centreLink provided by the sponsor.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Corinna Gerber, MSc principal investigator
University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YouGrabber in people with Cerebral Palsy and Stroke, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 2 inclusion and 3 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 24 Jul 2015. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
User satisfaction (Questionnaire about usability, motivation, general opinion) (time frame: week 2). 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 NCT02368223, which also lists 1 linked publication.
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 24 Jul 2015.