Gameplay between parent and child or adolescent with or without a disability for Disabilities Physical

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ohio State University College of Nursing, Columbus, OH
Disabilities Physical+2 More
Gameplay between parent and child or adolescent with or without a disability - Other
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new gaming platform that uses touch to translate player input, rather than having the player interact with the device directly. The goal is to create deeper connections between children with disabilities and their parents. Gameplay between a parent and child or adolescent, with or without a disability, is being used to treat physical disabilities. This type of gameplay has previously been approved by the FDA for a different condition. No patients in this trial will receive a placebo.

Eligible Conditions

  • Disabilities Physical
  • Cognitive Impairment (CI)

Treatment Effectiveness

Study Objectives

3 Primary · 16 Secondary · Reporting Duration: Pre gameplay and immediately post gameplay

1 hour
Establish the feasibility of cooperative gameplay between parents and adolescents with disabilities
Establish the feasibility of cooperative gameplay between parents and children without disabilities
Examine childs', adolescents', and parents ability to play the game through analysis of video recordings of game play
1 hour post-game play
Explore the parents' feelings of bonding with their child/adolescent using the "Connection & Bonding Questionnaire"
1 hour post-gameplay
Compare childs' and adolescents' Global, Mental, Physical, and Social Health using the single measure "Patient-Reported Outcomes Measurement Information System (PROMIS)" from Group 1, Group 2, and Group 3
Compare the parents' feelings of bonding using the "Connection & Bonding Questionnaire" with their child/adolescent in Group 1, Group 2, and Group 3
Compare the parents' feelings of whether the child's physical and psychological needs were met before gameplay using the "Child Needs Survey" in Group 1, Group 2, and Group 3
Semi-structured interviews with open ended questions to compare childs' and adolescents' (where appropriate), and parents' feelings about gameplay for fun, well being, quality of life in Group 1, Group 2, and Group 3
Immediately Post-gameplay and up to one week post-gameplay
Semi-Structured interviews with open-ended questions to explore childs' and adolescents' (where appropriate), and parents' feelings about gameplay for fun, well being, quality of life
Hour 1
Compare whether the child had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3
Compare whether the child had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3
Compare whether the parent had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3
Compare whether the parent had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3
Pre gameplay and immediately post gameplay
Explore whether the child had pain pre/post gameplay using visual analog scale
Explore whether the child had stress pre/post gameplay using visual analog scale
Explore whether the parent had pain pre/post gameplay using visual analog scale
Explore whether the parent had stress pre/post gameplay using visual analog scale
Pre-gameplay
Explore childs' and adolescents' Global, Mental, Physical, and Social Health using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure
Explore whether the parent felt that their child's physical and psychological needs were met before gameplay using the "Child Needs Survey"

Trial Safety

Trial Design

3 Treatment Groups

Parent and adolescent with mild to moderate cognitive or physical disability
1 of 3
Parent and adolescent with moderate to severe cognitive and/or physical disabili...
1 of 3
Parent and child without disability
1 of 3
Experimental Treatment

60 Total Participants · 3 Treatment Groups

Primary Treatment: Gameplay between parent and child or adolescent with or without a disability · No Placebo Group · N/A

Parent and adolescent with mild to moderate cognitive or physical disability
Other
Experimental Group · 1 Intervention: Gameplay between parent and child or adolescent with or without a disability · Intervention Types: Other
Parent and adolescent with moderate to severe cognitive and/or physical disability
Other
Experimental Group · 1 Intervention: Gameplay between parent and child or adolescent with or without a disability · Intervention Types: Other
Parent and child without disability
Other
Experimental Group · 1 Intervention: Gameplay between parent and child or adolescent with or without a disability · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre gameplay and immediately post gameplay
Closest Location: The Ohio State University College of Nursing · Columbus, OH
Photo of Columbus 1Photo of Columbus 2Photo of Columbus 3
2016First Recorded Clinical Trial
1 TrialsResearching Disabilities Physical
9 CompletedClinical Trials

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
693 Previous Clinical Trials
375,246 Total Patients Enrolled
Susan E Thrane, PhD, RNPrincipal InvestigatorOhio State University
2 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.