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NCT05867368 · ClinicalTrials.gov registry record · NA
Hand-Arm Bimanual Intensive Therapy in Virtual Reality Versus Standard Hand-Arm Bimanual Intensive Therapy
A NA study of Hemiplegic Cerebral Palsy, sponsored by University of Nebraska.
- Active
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT05867368: Active NA study of Hemiplegic Cerebral Palsy, sponsored by University of Nebraska.
NCT05867368 is a NA study of Hemiplegic Cerebral Palsy that is active but no longer recruiting, run by University of Nebraska. The registered enrollment target is 17 participants, below the 41-participant average among 5 other Hemiplegic Cerebral Palsy trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05867368, a NA study of Hemiplegic Cerebral Palsy, is active but no longer recruiting, sponsored by University of Nebraska.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this intervention study is- 1. To determine if a camp that solely uses VR software based on HABIT (HABIT-VR) still improves the motor planning and execution deficits in children with hemiplegic cerebral palsy (HCP) and 2. To determine if HABIT-VR improves bimanual coordination and affected hand function in children with HCP at least as well as a standard HABIT. Children with motor planning and execution deficits will receive 40 hours of either HABIT-VR or standard HABIT (4 hours per day, 5days/week, for two consecutive weeks), during which the investigators will track their performance of the tasks and their movements through 3-D motion tracking of the VR system. Post-camp, again the investigators will assess upper-extremity motor function. Additionally the investigators will assess pre to post camp improvement in hand function and bimanual coordination using Assisting Hand Assessment (AHA), Manual Ability Classification System (MACS), and manual dexterity using Box and Block test and 9 Hole Peg test.
Primary Outcome
The Assisting Hand Assessment (AHA)measure and describe how effectively individuals with a hand/arm impairment use their two hands together to perform bimanual tasks. The scale range from 22 points, meaning that the hand is not used at all, to 88 points meaning that the hand is used effectively, like a normal non-dominant hand. The score reflects the child's ability to use the affected hand in bimanual performance. Higher scores are better.
Conditions Studied
Interventions
- BEHAVIORAL HABIT-VR
- BEHAVIORAL Standard HABIT
Study Locations (1)
Nebraska
- University of Nebraska Medical Center, Munroe-Meyer Institute - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-07-18 |
| Est. Completion | 2026-09-21 |
| Phase | NA |
What the registry record for NCT05867368 still lists
NCT05867368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 41-participant average among 5 other Hemiplegic Cerebral Palsy trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Hemiplegic Cerebral Palsy appearing as the primary indexed condition, and to 2 interventions - of which HABIT-VR is the first listed.
NCT05867368 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT05867368 about?
NCT05867368 is a clinical study titled "Hand-Arm Bimanual Intensive Therapy in Virtual Reality Versus Standard Hand-Arm Bimanual Intensive Therapy". The goal of this intervention study is- 1. To determine if a camp that solely uses VR software based on HABIT (HABIT-VR) still improves the motor planning and execution deficits in children with hemiplegic cerebral palsy (HCP) and 2. To determine if HABIT-VR improves bimanual coordination and affect...
What is the current status of trial NCT05867368?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 17 participants. The study started on 2022-07-18. Estimated completion is 2026-09-21.
What conditions does trial NCT05867368 study?
This clinical trial studies the following conditions: Hemiplegic Cerebral Palsy.
What interventions are being tested in trial NCT05867368?
The interventions under investigation include: HABIT-VR (BEHAVIORAL), Standard HABIT (BEHAVIORAL).
Who is sponsoring clinical trial NCT05867368?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05867368 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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