What is the mechanism of action of this treatment?

Common treatments for Cerebral Palsy (CP) that aim to improve motor function, coordination, and hand use include intensive therapies like Hand-Arm Bimanual Intensive Therapy (HABIT) and its VR-based variant, HABIT-VR. These therapies work by providing repetitive, task-specific practice and sensory feedback, which enhance neuroplasticity and motor learning. VR-based therapies offer an engaging, interactive environment that can make exercises more effective by providing real-time feedback and immersive tasks. This is important for CP patients as it can lead to significant improvements in motor planning, execution, and bimanual coordination, thereby enhancing their daily functioning and independence.

What side effects are associated with this type of intervention?

Common treatments for Cerebral Palsy, such as Hand-Arm Bimanual Intensive Therapy (HABIT) and its VR-based variation (HABIT-VR), aim to improve motor planning, execution, bimanual coordination, and hand function through repetitive, task-specific exercises. Known side effects of these intensive therapies can include temporary muscle soreness, fatigue, and frustration. VR-based therapies may also cause eye strain, dizziness, and motion sickness. These side effects are generally mild and transient.

What prior FDA approvals exist?

The FDA has not specifically approved any treatments for Cerebral Palsy that directly align with the Virtual Reality-based Hand-Arm Bimanual Intensive Therapy (HABIT-VR) being studied. However, various therapies and interventions aimed at improving motor function and coordination in CP patients are commonly used. These include physical therapy, occupational therapy, and constraint-induced movement therapy (CIMT). While these therapies are not VR-based, they share similar goals of enhancing motor skills and functional use of the affected limbs. The use of VR in therapy is an emerging field and may offer new avenues for treatment pending further research and potential FDA approval.

What other types of research exist?

Promising alternatives to HABIT-VR for Cerebral Palsy patients include: 1) Constraint-Induced Movement Therapy (CIMT), which involves restricting the use of the unaffected limb to encourage use of the affected limb, 2) Robotics-Assisted Therapy, which uses robotic devices to provide repetitive, task-specific training, and 3) Functional Electrical Stimulation (FES), which applies electrical currents to stimulate muscle contractions and improve motor function. These therapies have shown potential in improving motor skills and coordination in CP patients.

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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 during the camp up to 40 hours

Awards & highlights

Summary

This trial is testing two types of therapy camps for children with one-sided cerebral palsy. One camp uses virtual reality games to help improve hand and arm movements, while the other uses traditional physical activities. Both methods aim to make kids use their weaker hand more, helping to improve its strength and coordination. Virtual reality (VR) is a relatively new and innovative approach to facilitate hand function in children with cerebral palsy.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the camp up to 40 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the camp up to 40 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the camp up to 40 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

9-Hole Peg Test Score

Assisting Hand Assessment Score

Box and Blocks Score

Secondary study objectives

Galvanic Skin Response

Heart Rate

Skin Temperature

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cerebral Palsy (CP) that aim to improve motor function, coordination, and hand use include intensive therapies like Hand-Arm Bimanual Intensive Therapy (HABIT) and its VR-based variant, HABIT-VR. These therapies work by providing repetitive, task-specific practice and sensory feedback, which enhance neuroplasticity and motor learning. VR-based therapies offer an engaging, interactive environment that can make exercises more effective by providing real-time feedback and immersive tasks. This is important for CP patients as it can lead to significant improvements in motor planning, execution, and bimanual coordination, thereby enhancing their daily functioning and independence.

HABIT+tDCS: a study protocol of a randomised controlled trial (RCT) investigating the synergistic efficacy of hand-arm bimanual intensive therapy (HABIT) plus targeted non-invasive brain stimulation to improve upper extremity function in school-age children with unilateral cerebral palsy.Hand-arm bimanual intensive therapy and daily functioning of children with bilateral cerebral palsy: a randomized controlled trial.Effectiveness of Hand-Arm Bimanual Intensive Therapy on Hand Function among Children with Unilateral Spastic Cerebral Palsy: A Meta-Analysis.

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Who is running the clinical trial?

University of NebraskaLead Sponsor

554 Previous Clinical Trials

1,145,416 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

Media Library

HABIT-VR Clinical Trial Eligibility Overview. Trial Name: NCT05867368 — N/A

Cerebral Palsy Research Study Groups: HABIT-VR, Standard HABIT

Cerebral Palsy Clinical Trial 2023: HABIT-VR Highlights & Side Effects. Trial Name: NCT05867368 — N/A

HABIT-VR 2023 Treatment Timeline for Medical Study. Trial Name: NCT05867368 — N/A

~6 spots leftby Sep 2025

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