Clinical trial NCT06506682: Comparing CIMT With Virtual Reality to CIMT
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Texas Scottish Rite Hospital for Children
Sponsor class: OTHER
Collaborators: name: Texas Woman's University
First posted: 2024-07-17
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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

Eligibility criteria: 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

Primary outcomes:
measure: Assisting Hand Assessment (AHA)
timeFrame: Baseline, pre-intervention and immediate post-intervention
Secondary outcomes:
measure: Melbourne Unilateral Upper Limb Assessment (MUUL)
timeFrame: Baseline, pre-intervention and immediate post-intervention
measure: ICF Brief Core Set for Cerebral Palsy
timeFrame: Baseline, pre-intervention
measure: Hypertonia Assessment Tool Assessment Tool (HAT)
timeFrame: Baseline, pre-intervention and immediate post-intervention
measure: Canadian Occupational Performance Measure Occupational Performance Measure (COPM)
timeFrame: Baseline, pre-intervention and immediate post-intervention
measure: sensory assessment
timeFrame: Baseline, pre-intervention and immediate post-intervention
measure: motion capture with electromyography (EMG)
timeFrame: Baseline, pre-intervention and immediate post-intervention
measure: option wearing of ActiGraphs on upper limbs
timeFrame: Baseline, pre-intervention and immediate post-intervention
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Scottish Rite for Children
state: Texas
Study officials:
References: