Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506682
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-05-29
Brief Title:
Comparing CIMT With Virtual Reality to CIMT
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to compare constraint induced movement therapy CIMT to CIMT combined with virtual reality technology CIMTVR 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 childs 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 CIMTVR 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 CIMTVR 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 pronationsupination 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
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 pronationsupination 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None