Developmental Coordination DisorderNCT02504385
The Effect of Virtual Reality on Motor Functioning and Participation Abilities Among Children With DCD
A study testing Virtual Reality Timocco and Conventional OT intervention in people with Developmental Coordination Disorder, run by Clalit Health Services.
Trial summary
The subjet of this study is to explore the effect of using virtual reality environment at the clinic and at home (using Timocco) on the motor and participation abilities of children with DCD (Developmental Coordination Disorder). Read more about this study
- Who is it for?
- Ages 4 to 6 years, men only
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Virtual Reality Timocco and Conventional OT intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2016
- 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 4 to 6 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children,
- native Hebrew speakers, between the ages of 4 and 6 diagnosed with DCD.
Who cannot join
- Children with complicated special needs (e.g., limited cognitive abilities, CP, ASD),
- children who received occupational or physical therapy interventions in the last 12 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Timocco's Virtual Reality Environment on the Motor Functioning and Participation Abilities Among Children With DCD
The subjet of this study is to explore the effect of using virtual reality environment at the clinic and at home (using Timocco) on the motor and participation abilities of children with DCD (Developmental Coordination Disorder).
The study will examine the efficacy of using virtual reality gaming environment (Timocco) for treating children with DCD and the use of remote therapy, by shifting the focus of therapy from the clinic to the home environment, using the remote control system of Timocco for home practice.
Read the detailed description
The efficacy of using VR (Virtual Reality) as a therapeutic tool as an integral part of Occupational Therapy intervention will be examined in this study. The study will be conducted in two stages: the first will be conducted at the Child Development Center of the Clalit HMO (Health Maintenance Organization), and the second will take place in the child's home.
The first intervention will take approximately 8 to 10 weeks, during which eight data collection sessions will be conducted, each of 45 minutes duration.
The study group will integrate the use of Timocco in occupational therapy sessions while the control group will be given conventional occupational therapy without using Timocco.
In the second intervention, the study group will be given access to the virtual-reality environment of Timocco to be used at home, and will not include therapy sessions at the Child Development Center. An assessment before and after intervention will be held for both groups for comparison.
- Conditions
- Developmental Coordination Disorder
- Being tested
- Virtual Reality Timocco, Conventional OT intervention
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TimoccoDevice
Timocco virtual reality system is a motion based comuter games that was designed for child development therpay. The children will play Timocco for 15 minutes every session.
Conventional OT interventionOther
Traditional Occupational Therapy intervention will be givven to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Timocco | Experimental | The study group will integrate the use of Timocco in occupational therapy sessions. The session will begin with 15 minutes of spatial activity involving sensory-motor practice, 15 minutes of activity in a virtual environment, and 15 minutes of structured activity at a desk. Receives: Device: Virtual Reality Timocco |
| Conventional OT intervention | Active comparator | The control group will be given conventional occupational therapy without using Timocco. In order to ensure that the therapy sessions in this group have a structure similar to that one used in the study group, each session will include 25 to 30 minutes of spatial sensory-motor activity, followed by 15 to 20 minutes of structured practice at a desk. Receives: Other: Conventional OT intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score in Motor and participation assessments (Henderson, S. & Sugden, D. 1992)
Measured: up to 18 weeks
Score in Timocco virtual reality system (number of wrong moves; Correct moves;response time)
data will be gathered using Timocco for the entire intervention
Measured: up to 18 weeks
Secondary outcomes (4)
DCD-Q (BN. Wilson, BJ. Kaplan, SG. Crawford and G. Roberts, 2009)
The questionnaire will be filled once at the beginning, once again at the end of phase 1 (in the clinic) , and last time after home practice (the second phase).
Measured: up to 18 weeks
Participation questionnaire (Yarus, 2010)
The questionnaire will be filled once at the beginning, once again at the end of phase 1 (in the clinic) , and last time after home practice (the second phase).
Measured: up to 18 weeks
DTVP-2 (developmental test of visual perception, 1993))
Screening test.
Measured: Baseline
Satisfaction questionnaire
Measured: up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Coordination DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Timocco Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504385
- Sponsor's protocol ID
- COM 0024-14
- Status last verified
- Jul 2015
- First submitted
- 29 Mar 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Timocco's Virtual Reality Environment on the Motor Functioning and Participation Abilities Among Children With DCD
- ClinicalTrials.gov ID
- NCT02504385
- Acronym / sponsor ID
- COM 0024-14
- Conditions
- Developmental Coordination Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- Timocco Ltd
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Jul 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 subjet of this study is to explore the effect of using virtual reality environment at the clinic and at home (using Timocco) on the motor and participation abilities of children with DCD (Developmental Coordination Disorder).
The study will examine the efficacy of using virtual reality gaming environment (Timocco) for treating children with DCD and the use of remote therapy, by shifting the focus of therapy from the clinic to the home environment, using the remote control system of Timocco for home practice.
Detailed description
The efficacy of using VR (Virtual Reality) as a therapeutic tool as an integral part of Occupational Therapy intervention will be examined in this study. The study will be conducted in two stages: the first will be conducted at the Child Development Center of the Clalit HMO (Health Maintenance Organization), and the second will take place in the child's home.
The first intervention will take approximately 8 to 10 weeks, during which eight data collection sessions will be conducted, each of 45 minutes duration.
The study group will integrate the use of Timocco in occupational therapy sessions while the control group will be given conventional occupational therapy without using Timocco.
In the second intervention, the study group will be given access to the virtual-reality environment of Timocco to be used at home, and will not include therapy sessions at the Child Development Center. An assessment before and after intervention will be held for both groups for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Timocco | Experimental | Device: Virtual Reality TimoccoThe study group will integrate the use of Timocco in occupational therapy sessions. The session will begin with 15 minutes of spatial activity involving sensory-motor practice, 15 minutes of activity in a virtual environment, and 15 minutes of structured activity at a desk. |
| Conventional OT intervention | Active comparator | Other: Conventional OT interventionThe control group will be given conventional occupational therapy without using Timocco. In order to ensure that the therapy sessions in this group have a structure similar to that one used in the study group, each session will include 25 to 30 minutes of spatial sensory-motor activity, followed by 15 to 20 minutes of structured practice at a desk. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children,
- native Hebrew speakers, between the ages of 4 and 6 diagnosed with DCD.
Key exclusion criteria (2 listed)
- Children with complicated special needs (e.g., limited cognitive abilities, CP, ASD),
- children who received occupational or physical therapy interventions in the last 12 months.
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 |
|---|---|---|
| Virtual Reality TimoccoTimocco virtual reality system is a motion based comuter games that was designed for child development therpay. The children will play Timocco for 15 minutes every session. | Device | Virtual Reality Timocco |
| Conventional OT interventionTraditional Occupational Therapy intervention will be givven to the control group. | Other | Conventional OT intervention |
Primary outcome
The score in Motor and participation assessments (Henderson, S. & Sugden, D. 1992)
Time frame: up to 18 weeks
Score in Timocco virtual reality system (number of wrong moves; Correct moves;response time)
Time frame: up to 18 weeks
data will be gathered using Timocco for the entire intervention
4 secondary outcomes
DCD-Q (BN. Wilson, BJ. Kaplan, SG. Crawford and G. Roberts, 2009)
Time frame: up to 18 weeks
Participation questionnaire (Yarus, 2010)
Time frame: up to 18 weeks
DTVP-2 (developmental test of visual perception, 1993))
Time frame: Baseline
Satisfaction questionnaire
Time frame: up to 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Timocco and Conventional OT intervention in people with Developmental Coordination Disorder, run by Clalit Health Services.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth Terkel-Dawer, M.D (50-7961922 ext. 972, ruthyte@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score in Motor and participation assessments (Henderson, S. & Sugden, D. 1992) (time frame: up to 18 weeks). The study lists 2 primary outcomes in all. 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 21 Jul 2015.