Comparing CIMT With Virtual Reality to CIMT

Blinded, Randomized Trial Comparing Constraint Induced Movement Therapy With Virtual Reality to Constraint Induced Movement Therapy Alone and the Correlation of Patient Characteristics With Responsiveness to Intervention

This study is being done to compare constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) and its impact on how the children with unilateral cerebral palsy use their arm. CIMT is an intensive upper limb therapy for children with one sided (unilateral) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities. Both groups will work on using both arms together to complete activities (bimanual training) as a way to transfer newly learned skills with one hand into two handed tasks. Assessments before and after the intervention will include clinical assessments (where a research team member observes the child doing tasks and ask questions), motion capture (where the child's movement is recorded using multiple cameras), and wearable sensors on the wrists (like a watch).

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Constraint Induced Movement Therapy; Behavioral: CIMT + VR

Detailed Description

The purpose of this research study is to compare the effectiveness of constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) in children with unilateral cerebral palsy. Both groups will also work on bimanual training (using both arms together to complete activities) as a way to transfer newly learned skills with one hand into two handed tasks. One group will receive CIMT, and the other group will receive CIMT and the VR technology. CIMT is an intensive upper limb therapy for children with unilateral (one sided) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities. Participants in the CIMT+VR group of this study protocol will do everything the CIMT group does PLUS will utilize at least 4 of the following VR technologies each day of intervention: FitMi, Tyromotion Pablo Upper Extremity, Hocoma Armeo® Spring Pediatric, Nintendo Wii, and Parrot Drone.

FitMi is a neurorehabilitation device that provides visual feedback on motor performance as the individual interacts with wireless switches (Flint Rehab, 2020). The targeted areas of upper limb function for the study include grasp, release, and thumb opposition.

Tyromotion Pablo® Upper Extremity is a sensor based rehabilitation device with interactive therapies for the whole body. It provides targeted training for pronation/supination and force regulation for gross grasp, tip pinch, lateral and three point pinch (Tyromotion). The targeted areas of upper limb function for the study include supination, grip strength, and pinch strength.

Hocoma Armeo® Spring Pediatric is a device that combines the assistance of an exoskeleton and VR games created to improve hand function in the pediatric population. The Hocoma Armeo ® Spring Pediatric encourages repetitive movement of the UL with the aim of increasing quantity and improving quality of movements and can be customized for range of motion and the amount of gravity assistance the exoskeleton provides the child while playing the VR games. The targeted areas of upper limb function for the study include upper arm movement and wrist extension.

Nintendo Wii® is a video game console that uses a handheld pointing device that detects movement in three directions. The system requires the individual to hold the controller in the hand while moving the upper extremity. The targeted areas of upper limb function for the study include stabilize and hold. Parrot Drone is a stable quadcopter mini drone that can be flown indoors and outdoors. It has an autopilot feature that keeps the drone steady even if the user lets go of the controller. The drone can be controlled with a remote control or from a smart device that will target isolated finger and thumb movements.

Participants may exit the study prior to completion of the program due to non-compliance, social and economic barriers, disease progression, misdiagnosis or no longer meeting inclusion criteria. Caregivers may withdraw their child from the study at any time for any reason.

Participants enrolled in the study will complete (1) baseline assessments, including physical assessments with motion capture, which will require a visit to Scottish Rite for Children (SRC), (2) an upper limb intervention program that will require visits to Scottish Rite each weekday for two weeks, and (3) post-intervention assessments, including physical assessments with motion capture, that will require a visit to Scottish Rite, for a total of 12 visits. Assessment visits will each take about 3 hours and group intervention sessions will last 6 hours each day. Participants will also be asked as an option to wear an accelerometer (ActiGraph) on their wrists during waking hours (approximately 12 hours per day) 2-3 days before and after the intervention and during the 2 weeks of intervention for a total of 16-18 days. Total study duration for participants will be about 4 weeks

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75219
      • Scottish Rite for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have cerebral palsy (a brain injury that causes muscle movement problems) or are a non-progressive brain injury to the developing brain and have difficulty using one of your arms

Exclusion Criteria:

• unable to complete assessment protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CIMT; Both groups will participate in 60 hours of intensive therapy over 10 days at SRC (6 hours per day Monday-Friday) following the established 'Pirate Camp' CIMT protocol. The full protocol can be found at: https://twu.edu/occupational-therapy/Camp-Based-Augmented-CIMT-Guide/. Both groups will participate in child friendly outdoor and indoor activities that promote the use of the involved side for example; parachute games, sock toss, penny pick up.	Behavioral: Constraint Induced Movement Therapy; CIMT is an intensive upper limb therapy for children with unilateral (one sided) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities; Other Names: CIMT
Experimental: CIMT+VR; The CIMT+VR group will use the VR technology to work on upper limb motor skills for approximately two hours per day (4 of the activities described under Key Information at the beginning of this form) while the CIMT-only group will participate in traditional motor-based task-specific activities. Both the VR games and traditional intervention will target the improvement of the same upper limb domains.	Behavioral: CIMT + VR; Participants in the CIMT+VR group of this study protocol will do everything the CIMT group does PLUS will utilize at least 4 of the following VR technologies each day of intervention: FitMi, Tyromotion Pablo® UpperExtremity, Hocoma Armeo® Spring Pediatric, Nintendo Wii, and Parrot Drone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assisting Hand Assessment (AHA)	assessment of bimanual hand skills in children with cerebral palsy well the involved hand performs during two handed activities,	Baseline, pre-intervention and immediate post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melbourne Unilateral Upper Limb Assessment (MUUL)	how well the involved hand works and active range of motion	Baseline, pre-intervention and immediate post-intervention
ICF Brief Core Set for Cerebral Palsy	Interview based on ICR Core Set	Baseline, pre-intervention
Hypertonia Assessment Tool Assessment Tool (HAT)	tone assessment	Baseline, pre-intervention and immediate post-intervention
Canadian Occupational Performance Measure Occupational Performance Measure (COPM)	Goal setting	Baseline, pre-intervention and immediate post-intervention
sensory assessment	assess sensory of hand stereognosis, two point discrimination, proprioception,	Baseline, pre-intervention and immediate post-intervention
motion capture with electromyography (EMG)	while completing the AHA	Baseline, pre-intervention and immediate post-intervention
option wearing of ActiGraphs on upper limbs	real time tracking of use of upper extremities	Baseline, pre-intervention and immediate post-intervention

Collaborators and Investigators

• Sponsor: Texas Scottish Rite Hospital for Children
• Collaborators: Texas Woman's University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: STU 2021-0271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No