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Virtual Reality Therapy for Cerebral Palsy (HABIT-VR Trial)
N/A
Recruiting
Led By James E Gehringer, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 week after the camp
Awards & highlights
HABIT-VR Trial Summary
This trial will assess if VR can help kids with motor planning & execution deficits improve hand function & bimanual coordination.
Who is the study for?
This trial is for children diagnosed with hemiplegic cerebral palsy (HCP) who can follow a two-week therapy program. They must have certain levels of manual ability but not have other neurological conditions, visual impairments, or musculoskeletal issues that would interfere with the therapy.Check my eligibility
What is being tested?
The study compares two types of therapies: Standard Hand-Arm Bimanual Intensive Therapy (HABIT) and a virtual reality version called HABIT-VR. Each child will receive 40 hours of treatment over two weeks to improve hand function and coordination.See study design
What are the potential side effects?
Since this is a physical and occupational therapy-based intervention involving virtual reality, side effects may include fatigue or discomfort from repetitive movements. VR-related side effects could include dizziness or nausea.
HABIT-VR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 1 week after the camp for 5 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 week after the camp for 5 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
9-Hole Peg Test Score
Assisting Hand Assessment Score
Box and Blocks Score
Secondary outcome measures
Galvanic Skin Response
Heart Rate
Skin Temperature
HABIT-VR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HABIT-VRExperimental Treatment1 Intervention
Children will receive hand arm bimanual intensive therapy, however, it will be through the use of custom virtual reality games. Children will receive 40 hrs of one-on-one bimanual therapy, delivered through the virtual reality games. Activities will be self-selected, but all games have a task constraint, requiring both hands to succeed.
Group II: Standard HABITActive Control1 Intervention
Children will receive hand arm bimanual intensive therapy the way it is typically delivered. Children will receive 40 hrs of one-on-one bimanual therapy, delivered as play. Activities will be self-selected, but all options will require both hands to succeed.
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Who is running the clinical trial?
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,714 Total Patients Enrolled
3 Trials studying Cerebral Palsy
1,074 Patients Enrolled for Cerebral Palsy
James E Gehringer, PhDPrincipal InvestigatorUniversity of Nebraska
1 Previous Clinical Trials
20 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is visually impaired or blind.My child has a neurological condition affecting their ability to move their arms.My child has a condition affecting their ability to follow objects with their eyes.My parents agree to and will follow the study's requirements.My child has been diagnosed with HCP.My child can use their hands but with varying levels of difficulty.My child has a physical deformity that affects their ability to handle objects.
Research Study Groups:
This trial has the following groups:- Group 1: HABIT-VR
- Group 2: Standard HABIT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research include elderly subjects aged 55 and above?
"Participants that meet the enrollment criteria must be between 6 and 16 years old."
Answered by AI
Is it feasible for me to join this clinical trial?
"To participate in this research, children with cerebral palsy between the ages of 6 and 16 can be selected. The trial is looking to enroll around 20 patients."
Answered by AI
Are there any vacancies remaining for participants in this trial?
"Clinicaltrials.gov reveals that this research project is presently recruiting patients, having initially been posted on July 18th 2022 and being most recently updated in May 15th 2023."
Answered by AI
How many individuals has the team recruited for this research endeavor?
"Affirmative. According to the clinical trials website, this experiment is actively seeking participants since its initial post on July 18th 2022 and most recent update being May 15th 2023. Only twenty individuals are required for participation from a single medical centre."
Answered by AI
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