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Baseline Phase (10 or 21 days) for Developmental Coordination Disorder

N/A

Recruiting

Led By Elaine Biddiss, PhD

Research Sponsored by Holland Bloorview Kids Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any motor condition that can be addressed by the Bootle Blast system

Aged 6-17 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up last day of baseline phase

Awards & highlights

Study Summary

This trial is testing a 3D video game which could help kids with physical disabilities develop motor skills. It will assess home use, feasibility and user experience to inform product, training and resource development.

Who is the study for?

This trial is for young people aged 6-17 with various motor conditions who are interested in improving their motor skills using a video game called Bootle Blast. Participants need intermittent internet access, the ability to engage in video calls, and must be able to communicate in English. They also require caregiver support and should not have uncontrolled epilepsy triggered by video games or any condition that makes physical activity unsafe.Check my eligibility

What is being tested?

The study tests the 'real-world' use of Bootle Blast, a mixed reality video game designed to help children develop motor skills at home. Over 14 weeks, participants will play Bootle Blast while researchers assess how easy it is to set up and use independently, identify what helps or hinders its use, and evaluate its perceived value based on user experience.See study design

What are the potential side effects?

Since Bootle Blast is a non-invasive video game used for therapy purposes, side effects may include typical gaming-related issues such as eye strain or minor musculoskeletal discomfort due to repetitive movements during gameplay.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a motor condition that Bootle Blast can help.

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I am between 6 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of baseline phase; 8th week of intervention phase; 3rd week of follow-up phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of baseline phase; 8th week of intervention phase; 3rd week of follow-up phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of baseline phase; 8th week of intervention phase; 3rd week of follow-up phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Canadian Occupational Performance Measure (COPM)

Performance Quality Rating Scale (PQRS)

Secondary outcome measures

Access To Therapy Services Questionnaire

Child and Adolescent Factors Inventory (CAFI)

Children & Adolescent Scale of Participation (CASP)

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Baseline Phase (10 or 21 days)Experimental Treatment1 Intervention

In this study, participants will be randomly allocated to a baseline (A) phase that is further divided into two sub-phases, with different durations of either 10 or 21 days. The allocation to different durations of the baseline phase is randomized in order to mitigate threats to internal validity. During the baseline (A) phase, a representative baseline will be established through repeated measurements of the PQRS. Following the baseline phase (A), the 8-week intervention phase (B) is implemented, followed by a second 3-week (A) phase. There is no separate control group in this study, and all participants receive the same intervention during the intervention phase (B).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Holland Bloorview Kids Rehabilitation HospitalLead Sponsor

67 Previous Clinical Trials

14,014 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,454 Total Patients Enrolled

Elaine Biddiss, PhDPrincipal InvestigatorBloorview Research Institute

4 Previous Clinical Trials

52 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current quota for participants in this investigation?

"Indeed, clinicaltrials.gov's records reveal that this medical study is presently accepting subjects to participate. This experiment was initially posted on July 7th 2022 and has been recently updated on December 6th 2023. The research seeks 60 volunteers from a single site."

Answered by AI

What goals is this research project aspiring to accomplish?

"The primary outcome being evaluated in this trial is the Performance Quality Rating Scale (PQRS) which will be monitored throughout the Baseline, Intervention and Follow-up Phases. Secondary outcomes include observations of user manual utilization during device set up as well as complexity levels of Bottle Blast setup process - both recorded through video call on Zoom platform - plus demographic data collected via an email survey hosted on REDcap."

Answered by AI

What kind of individuals are qualified to participate in this study?

"To become a participant in this medical trial, patients must possess motor skills disorder and be between the ages of 6 and 17. A maximum of 60 people can join."

Answered by AI

Is this research study presently recruiting participants?

"As indicated by clinicaltrials.gov, this medical study is currently enrolling patients and has been since July 7th 2022; the trial was last updated on December 6th 2023."

Answered by AI

Does this research undertaking permit adolescents to partake?

"This clinical trial exclusively welcomes patients between 6 and 17 years of age. It is one of a total of 644 trials dedicated to minors, with 2000 for seniors aged 65 or above."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bootle Blast: Understanding the Family Experience

2022. "Bootle Blast: Understanding the Family Experience". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06161168.

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