Disability PhysicalNCT06319430
Technology in Play for Children With Physical Disabilities: the Dice Model of Play
A study testing robots and conventional in people with Disability Physical and Disabilities Mental, run by University of Manitoba at 1 site in Canada.
Trial summary
Play is an important activity for children. Almost all children play, but what is play? It is not easy to define play. In the past, people believed that children played to burn their energy. Now, it is known that play is important for children's growth. Some kids with disabilities cannot play. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Disability Physical, Disabilities Mental
- What is being tested?
- robots and conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2025to 28 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having a disability or typically developed
- Between 3 to 9 years old
- Speaking and understanding English or Persian
- Living in Winnipeg
Who cannot join
- Not receiving play therapy within the last three months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Rehabilitation Centre for Children
Winnipeg, Manitoba, R3E 3G1
Liz Hammond
About this study
Official title: The Role of Technology in Facilitating Play for Children With Physical Disabilities: Development of the Dice Model of Play
Play is an important activity for children. Almost all children play, but what is play? It is not easy to define play. In the past, people believed that children played to burn their energy. Now, it is known that play is important for children's growth. Some kids with disabilities cannot play. Many experts use play to teach children specific skills. People often forget that play is a child's right. It is important to help all children play. The first step is to define play and find what features are important in helping a child with a disability play.
There are some models of play. But they are not complete. They do not look at play as a whole. Some models are just about playfulness, and some are about playing with others. Having a model that defines play helps researchers and clinicians think about play and the different parts of it. Then, when a child cannot play, experts can fix the part that is not working. Investigators want to introduce a model of play in this project. Investigators want to edit and complete it in three steps. First, Investigators will ask parents and children with disabilities about things that help or do not help them play; then, investigators will give Lego robots to children that they will build with help and play with them for a few weeks. And at the end, investigators will ask therapists and other experts about our model of play. This model will be edited during the study.
Read the detailed description
The study is designed in three phases, employing a mixed-method approach that integrates qualitative and quantitative methods. Phase 1 involves exploring the alignment of the Dice Model of Play with the experiences of 10 children (aged 3-9, diagnosed with different abilities, and typically developed) and their guardians through semi-structured interviews and content analysis; Phase 2 examines the practical application of the model with a cross-over design. Up to 20 children with different abilities will build their Lego robots within a co-design and will play with that robot for four sessions. The other group will play with conventional toys for four sessions. They will switch after finishing those sessions. Sessions will be directed by a master of occupational therapy student supervised by Dr. Jacquie Ripat, a registered occupational therapist in Manitoba. Assessments will be Test of Playfulness (TOP), enjoyment (PPE_DC), and play skills (ChIPPA-2) three times at the start, switching point, and last session. A go-along interview will be conducted in the co-design. Lastly, Phase 3 seeks expert opinions on the revised Dice Model of Play's clarity, relevance, and applicability, using online focus groups with professionals in occupational therapy, psychology, and computer science. The study aims to modify and enhance the model based on the findings from these phases.
- Conditions
- Disability Physical, Disabilities Mental
- Being tested
- robots, conventional
- Keywords
- play and playthings, Assistive technology, Pediatric ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotsOther
LEGO robots with adaptation according to child's age and developmental skills.
conventionalOther
A pack of conventional play tools consists of dolls, teddy bears, miniature wild animals, and small cars. All are available, and the child can choose to play with them.
| Study group | Role | What they receive |
|---|---|---|
| robots | Experimental | Participants will be randomly allocated to groups A or B. Those in group A will co-design and build their LEGO™ robot, using the researcher's assistance, as led by the child. A go-along interview will be conducted during the co-design with the child . The co-design session will be video recorded to provide context, visual data, and to inform the qualitative analysis. Videos will be deleted right after analysis. A research assistant (RA) will visit the participant's home twice a week for 30 to 45 minutes (after school or on the weekend) to play with the child and their built LEGO™ robots for four weeks (4 sessions total). Receives: Other: robots |
| conventional toys | Experimental | Group B will engage in the same process of 4 play intervention sessions over four weeks with the research assistant; however, they will receive conventional play tools. The RA will carry a prepared play pack for the play intervention session. Receives: Other: conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Playfulness
The Test of playfulness (TOP) version 4 (Bundy, 1998) is an observational test that covers four main elements of playfulness: intrinsic motivation, internal control, freedom of reality, and framing within 29 Likert scale related to extent, intensity, and skillfulness and is used for children between 15 months and 18 years old. Upper scores means better play skills, no cut-off score.
Measured: before the session 1, after session 8, after session 16, each time 10 to 20 minutes.
The Child Initiated Pretend Play Assessment (ChIPPA-2)
The Child Initiated Pretend Play Assessment (ChIPPA-2) provides a play tool pack consisting of two different sets: conventional and symbolic play tools. Percentage of Elaborated Play Actions (PEPA), Number of Object Substitutions (NOS), and Number of Imitations (NIA) are reported for conventional, symbolic, and general pretend play. Higher PEPA and NOS and lower NIA scores show better play skills. There are Z-scores for each age range that child can be compared with typically developed children.
Measured: before the session 1, after session 8, after session 16, each time 18 minutes for 3 years old children and 30 minutes for 4-8 years old children.
The Pretend Play Enjoyment-Developmental Checklist (PPE-DC)
The Pretend Play Enjoyment-Developmental Checklist (PPE-DC) measures play enjoyment and covers some aspects of pretend play, such as sequences, storytelling, playing with dolls, object substitution, roleplay, and social interaction, from parents and experts prospectives within two different scoresheets, items are defined for different developmental ages and by choosing one item, the play developmental age in each subcategory can be estimated. Play enjoyment score is better when is higher.
Measured: before the session 1, after session 8, after session 16, each time almost 10 minutes for parents and 10 minutes for researcher.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start6 Feb 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The primary purpose is validation of..........
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Centre for Children, Canada
- Responsible party
- Principal investigator, Minoo Dabiri Golchin, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319430
- Sponsor's protocol ID
- HS26236(H2023:343)
- Status last verified
- Oct 2025
- First submitted
- 21 Feb 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Technology in Facilitating Play for Children With Physical Disabilities: Development of the Dice Model of Play
- ClinicalTrials.gov ID
- NCT06319430
- Acronym / sponsor ID
- HS26236(H2023:343)
- Conditions
- Disability Physical, Disabilities Mental
- Keywords
- play and playthings, Assistive technology, Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Rehabilitation Centre for Children, Canada
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- 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.
Play is an important activity for children. Almost all children play, but what is play? It is not easy to define play. In the past, people believed that children played to burn their energy. Now, it is known that play is important for children's growth. Some kids with disabilities cannot play. Many experts use play to teach children specific skills. People often forget that play is a child's right. It is important to help all children play. The first step is to define play and find what features are important in helping a child with a disability play.
There are some models of play. But they are not complete. They do not look at play as a whole. Some models are just about playfulness, and some are about playing with others. Having a model that defines play helps researchers and clinicians think about play and the different parts of it. Then, when a child cannot play, experts can fix the part that is not working. Investigators want to introduce a model of play in this project. Investigators want to edit and complete it in three steps. First, Investigators will ask parents and children with disabilities about things that help or do not help them play; then, investigators will give Lego robots to children that they will build with help and play with them for a few weeks. And at the end, investigators will ask therapists and other experts about our model of play. This model will be edited during the study.
Detailed description
The study is designed in three phases, employing a mixed-method approach that integrates qualitative and quantitative methods. Phase 1 involves exploring the alignment of the Dice Model of Play with the experiences of 10 children (aged 3-9, diagnosed with different abilities, and typically developed) and their guardians through semi-structured interviews and content analysis; Phase 2 examines the practical application of the model with a cross-over design. Up to 20 children with different abilities will build their Lego robots within a co-design and will play with that robot for four sessions. The other group will play with conventional toys for four sessions. They will switch after finishing those sessions. Sessions will be directed by a master of occupational therapy student supervised by Dr. Jacquie Ripat, a registered occupational therapist in Manitoba. Assessments will be Test of Playfulness (TOP), enjoyment (PPE_DC), and play skills (ChIPPA-2) three times at the start, switching point, and last session. A go-along interview will be conducted in the co-design. Lastly, Phase 3 seeks expert opinions on the revised Dice Model of Play's clarity, relevance, and applicability, using online focus groups with professionals in occupational therapy, psychology, and computer science. The study aims to modify and enhance the model based on the findings from these phases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary purpose is validation of..........
| Arm | Type | Receives |
|---|---|---|
| robots | Experimental | Other: robotsParticipants will be randomly allocated to groups A or B. Those in group A will co-design and build their LEGO™ robot, using the researcher's assistance, as led by the child. A go-along interview will be conducted during the co-design with the child . The co-design session will be video recorded to provide context, visual data, and to inform the qualitative analysis. Videos will be deleted right after analysis. A research assistant (RA) will visit the participant's home twice a week for 30 to 45 minutes (after school or on the weekend) to play with the child and their built LEGO™ robots for four weeks (4 sessions total). |
| conventional toys | Experimental | Other: conventionalGroup B will engage in the same process of 4 play intervention sessions over four weeks with the research assistant; however, they will receive conventional play tools. The RA will carry a prepared play pack for the play intervention session. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Having a disability or typically developed
- Between 3 to 9 years old
- Speaking and understanding English or Persian
- Living in Winnipeg
Key exclusion criteria (1 listed)
- Not receiving play therapy within the last three 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 |
|---|---|---|
| robotsLEGO robots with adaptation according to child's age and developmental skills. | Other | robots |
| conventionalA pack of conventional play tools consists of dolls, teddy bears, miniature wild animals, and small cars. All are available, and the child can choose to play with them. | Other | conventional toys |
Primary outcome
Test of Playfulness
Time frame: before the session 1, after session 8, after session 16, each time 10 to 20 minutes.
The Test of playfulness (TOP) version 4 (Bundy, 1998) is an observational test that covers four main elements of playfulness: intrinsic motivation, internal control, freedom of reality, and framing within 29 Likert scale related to extent, intensity, and skillfulness and is used for children between 15 months and 18 years old. Upper scores means better play skills, no cut-off score.
The Child Initiated Pretend Play Assessment (ChIPPA-2)
Time frame: before the session 1, after session 8, after session 16, each time 18 minutes for 3 years old children and 30 minutes for 4-8 years old children.
The Child Initiated Pretend Play Assessment (ChIPPA-2) provides a play tool pack consisting of two different sets: conventional and symbolic play tools. Percentage of Elaborated Play Actions (PEPA), Number of Object Substitutions (NOS), and Number of Imitations (NIA) are reported for conventional, symbolic, and general pretend play. Higher PEPA and NOS and lower NIA scores show better play skills. There are Z-scores for each age range that child can be compared with typically developed children.
The Pretend Play Enjoyment-Developmental Checklist (PPE-DC)
Time frame: before the session 1, after session 8, after session 16, each time almost 10 minutes for parents and 10 minutes for researcher.
The Pretend Play Enjoyment-Developmental Checklist (PPE-DC) measures play enjoyment and covers some aspects of pretend play, such as sequences, storytelling, playing with dolls, object substitution, roleplay, and social interaction, from parents and experts prospectives within two different scoresheets, items are defined for different developmental ages and by choosing one item, the play developmental age in each subcategory can be estimated. Play enjoyment score is better when is higher.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robots and conventional in people with Disability Physical and Disabilities Mental, run by University of Manitoba at 1 site in Canada.
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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minoo Dabiri Golchin, Ph.D. (204-789-3897, Minoo.DabiriGolchin@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Playfulness (time frame: before the session 1, after session 8, after session 16, each time 10 to 20 minutes.). The study lists 3 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 5 May 2026.