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Virtual Reality Occupational Therapy for Hemiplegia in Kids (MOVE-IT Trial)

N/A

Recruiting

Research Sponsored by Barron Associates, Inc.

Eligibility Criteria Checklist

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

Must have

Diagnosis of hemiplegia resulting from cerebral palsy, stroke, or other form of brain injury

Participant has antigravity strength in the affected UE at the elbow to at least 45 degrees of active flexion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 minutes

Awards & highlights

MOVE-IT Trial Summary

This trial will compare the efficacy of MOVE-IT, a remotely supervised home exercise program, to usual care for recovery of upper extremity function in children with hemiplegia.

Who is the study for?

This trial is for children with hemiplegia due to cerebral palsy, stroke, or brain injury. They must be medically stable and able to perform certain physical tasks like maintaining postures and controlled arm movements. Kids should communicate effectively with familiar people and pass a basic color-matching test. They can't join if they've had recent intensive therapies, uncontrolled seizures, severe visual impairments that affect computer use, or conditions causing agitation/stress from the study.Check my eligibility

What is being tested?

The MOVE-IT Intervention involves using virtual reality in a home exercise program for kids with hemiplegia to improve arm function. It's compared against usual care (UCT Control) in this rater-blinded randomized controlled trial where participants are randomly assigned to either group.See study design

What are the potential side effects?

Since this is an occupational therapy intervention involving virtual reality exercises, side effects may include mild discomfort or dizziness during VR use, potential stress from following the exercise regimen at home, and possible frustration if difficulties arise while performing tasks.

MOVE-IT Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have hemiplegia due to cerebral palsy, stroke, or brain injury.

Select...

I can lift my arm at the elbow to at least a 45-degree angle.

Select...

My child can hold their head up, sit, and control their arm movements.

Select...

I can lift my arm in different directions while sitting up.

Select...

My child has difficulty using their hand to handle objects.

MOVE-IT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Jebsen Taylor Hand Function Test (JTHFT)

Secondary outcome measures

Pediatric Evaluation and Disability Inventory Computer Adaptive Test (PEDI-CAT)

Pediatric Motor Activity Log

Quality of Upper Extremity Skills Test (QUEST)

+2 more

MOVE-IT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MOVE-IT Home Exercise Program (HEP)Experimental Treatment1 Intervention

Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.

Group II: Usual Care Treatment (UCT) ControlActive Control1 Intervention

Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Barron Associates, Inc.Lead Sponsor

6 Previous Clinical Trials

186 Total Patients Enrolled

University of VirginiaOTHER

754 Previous Clinical Trials

1,245,025 Total Patients Enrolled

Duke UniversityOTHER

2,363 Previous Clinical Trials

3,420,438 Total Patients Enrolled

Media Library

MOVE-IT Intervention (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04510857 — N/A

Occupational Therapy Research Study Groups: MOVE-IT Home Exercise Program (HEP), Usual Care Treatment (UCT) Control

Occupational Therapy Clinical Trial 2023: MOVE-IT Intervention Highlights & Side Effects. Trial Name: NCT04510857 — N/A

MOVE-IT Intervention (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04510857 — N/A

Frequently Asked Questions

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

To whom is access to this experiment available?

"This clinical trial is recruiting 48 children between the ages of 4 and 12 who have virtual reality experience. To be eligible, candidates must meet certain criteria including being medically sound, demonstrating anti-gravity head/trunk posture with controlled arm movements (GMFCS rating I - IV), having effective communication skills with familiar partners but not unfamiliar ones (CFCS rating I - III), diagnosis of hemiplegia due to cerebral palsy/stroke or other brain injury(MACS II - V) , antigravity elbow flexion strength at least 45 degrees in affected upper extremity (UE). Shoulder muscles should have 30 degree active"

Answered by AI

Are there any slots still available to join this trial?

"The clinical trial in question, which was initially posted March 1st 2022 and last updated August 16th 2022 is no longer recruiting. However, 44 other trials are currently searching for participants."

Answered by AI