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VR Gaming Exercise for Cerebral Palsy

Phase 1
Recruiting
Led By Byron Lai, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Medical diagnosis of cerebral palsy
Between the ages of 13-24 years to accommodate the World Health Organization definition of youth and the minimum age of 13 years specified by the Quest
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 6, week 12
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will compare the effects of a 12-week home-based exercise program using VR technology to a control group who does no exercise. They will also interview participants to try and understand why people do or don't participate in the program.

Who is the study for?
This trial is for youth aged 13-24 with cerebral palsy who have a caregiver, can exercise using their arms, and aren't already highly active. They need physician clearance to participate and must have Wi-Fi at home. It's not for those who are completely blind or deaf, cannot use their arms for exercise, or do more than 150 minutes of moderate-to-vigorous exercise weekly.Check my eligibility
What is being tested?
The study tests if playing virtual reality games at home for 12 weeks can improve heart health in young people with cerebral palsy compared to waiting without treatment. Participants' experiences will also be explored through interviews after the gaming period or upon dropping out.See study design
What are the potential side effects?
Virtual reality exergaming may cause dizziness, nausea, eye strain, or motion sickness in some individuals. The risk of physical injury from accidental falls during gameplay should also be considered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with cerebral palsy.
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I am between 13 and 24 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 6, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 6, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in C-reactive protein (hsCRP)
Changes in Hemoglobin A1C
Changes in body weight
+8 more
Secondary outcome measures
Adherence to the exercise intervention prescription
Compliance to the intervention coaching calls
Compliance to the remote data collections
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate Start - Virtual Reality ExergamingExperimental Treatment1 Intervention
12 weeks of virtual reality active video gaming using immersive commercially available equipment, with adapted games for people to play in the seated position. Maintain normal eating/nutritional behaviors.
Group II: Wait-list ControlActive Control1 Intervention
Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,551 Previous Clinical Trials
2,289,015 Total Patients Enrolled
8 Trials studying Cerebral Palsy
398 Patients Enrolled for Cerebral Palsy
Byron Lai, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

Virtual Reality Exergaming Clinical Trial Eligibility Overview. Trial Name: NCT05336227 — Phase 1
Cerebral Palsy Research Study Groups: Immediate Start - Virtual Reality Exergaming, Wait-list Control
Cerebral Palsy Clinical Trial 2023: Virtual Reality Exergaming Highlights & Side Effects. Trial Name: NCT05336227 — Phase 1
Virtual Reality Exergaming 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336227 — Phase 1

Frequently Asked Questions

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

What is the size of the cohort involved in this medical research?

"Affirmative. Clinicaltrials.gov records show that this biomedical research is still looking for volunteers, having been first posted on June 1st 2022 and revised recently on June 2nd of the same year. 34 patients are required to be recruited from a single site in total."

Answered by AI

What criteria must be fulfilled in order to participate in this research?

"The trial will enrol 34 adolescents aged 13-24 with cerebral palsy. The primary requirements are that they must receive a medical clearance to participate, possess an internet connection in their home, be diagnosed with CP and have at least one caregiver available to support them through the process."

Answered by AI

What aims are this trial trying to achieve?

"This trial is monitoring for changes in hsCRP over a 0-6-12 week period, with secondary measures including coaching call compliance, total intervention play time, and participant perceptions of completing the intervention."

Answered by AI

To what extent could Virtual Reality Exergaming endanger people's health?

"The safety assessment of Virtual Reality Exergaming has been rated a 1, due to the limited amount of clinical evidence available that supports its efficacy and safety at this time."

Answered by AI

Does this research program admit individuals aged eighty-five or older?

"This trial is specifically looking for participants aged 13 to 24, with 139 studies open to those under 18 and 26 trials available for people 65 years or older."

Answered by AI

Is this research study presently enlisting participants?

"Examining the information on clinicaltrials.gov, this medical trial is actively looking for participants. The study was initially advertised on June 1st 2022 and last adjusted a day later."

Answered by AI
~4 spots leftby Jun 2024