Ignite Creation Date:
2024-05-06 @ 9:09 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02914925
Status:
UNKNOWN
Last Update Posted:
2016-09-26
First Post:
2016-09-21
Brief Title:
The Effect of Combined Armeospring and CIT on Neuro-motor and Functional Recovery in Children With Unilateral CP
Sponsor:
St Marys Hospital for Children
Organization:
St Marys Hospital for Children
Study Overview
Official Title:
The Effect of Combined Armeospring Pediatric and Constraint Induced Therapy on Neuro-motor and Functional Recovery in Children With Unilateral Cerebral Palsy
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the use of a commercially available arm weight supporting training system ArmeoSpring in conjunction with Constraint Induced Therapy CIT for improving upper extremity function for children with unilateral cerebral palsy In addition the study aims to assess the potential cortical changes with ArmeoSpring therapy and CIT with the use of the Transcranial Magnetic Stimulation TMS motor mapping
This within-subjects repeated-measures study will be conducted at St Marys Hospital for Children Subjects will be recruited from the general population A sample size of 10 participants is required for the study Minority and gender distributions of this study are expected to reflect the distributions in the general population of this region
Therapy Participating children will have their unaffected arm placed in a sling The sling is placed at the start of the day and the child is encouraged to have this on during all therapy sessionsThe affected arm will be used for repetitive therapeutic activitiesTherapy sessions will include activities aimed at building motor learning skills
TMS will be used to map the brain Participants will have MRI of the brain that is T1 weighted with 09 -11 voxel size to allow for on-screen navigation of the cerebral cortex while performing TMSThe stimulating coil will be held to the scalp over each M1 hemisphere and an induced electrical current passed through the coil will create a magnetic pulse that stimulates the brain
Children will be assessed using functional hand tests and TMS
This within-subjects repeated-measures study will be conducted at St Marys Hospital for Children Subjects will be recruited from the general population A sample size of 10 participants is required for the study Minority and gender distributions of this study are expected to reflect the distributions in the general population of this region
Therapy Participating children will have their unaffected arm placed in a sling The sling is placed at the start of the day and the child is encouraged to have this on during all therapy sessionsThe affected arm will be used for repetitive therapeutic activitiesTherapy sessions will include activities aimed at building motor learning skills
TMS will be used to map the brain Participants will have MRI of the brain that is T1 weighted with 09 -11 voxel size to allow for on-screen navigation of the cerebral cortex while performing TMSThe stimulating coil will be held to the scalp over each M1 hemisphere and an induced electrical current passed through the coil will create a magnetic pulse that stimulates the brain
Children will be assessed using functional hand tests and TMS
Detailed Description:
Objective This study will evaluate the effect of combined Armeospring pediatric and Constraint Induced Therapy on neuro-motor and functional recovery in children with unilateral cerebral palsy
Background Children with unilateral cerebral palsy CP tend not to use their impaired arm and hand throughout life This disuse of a limb during postnatal development can stunt the activity-dependent structural and functional development of the motor system Enabling young children to more readily use their affected extremity is likely to increase the competitive ability of the affected side and can improve the functional and anatomical integrity of the motor system
Several studies have shown that applying a restraint to the less affected hand with intensive repetitive use of the more affected hand has significant effect in overcoming learned non-use There is evidence that suggests that CIT produced significant cortical reorganization in adults with chronic and sub-acute cerebrovascular accident CVA and patients with chronic traumatic brain injury and for the lower limb of patients with CVA
The associations between motor physiology and motor performance in children with hemiplegic CP are being examined Recent study shows that children whose impaired hand is controlled by contralateral connections from the unaffected motor cortex show greater improvement to intensive hand training than children whose impaired hand is controlled by ipsilateral connections from the affected motor cortex
In order for future therapies to be applied selectively to brain regions most important in mediating recovery it is important to determine the location of plastic changes produced by intensive practice
Subject Population Children with CP Hemiplegia
Design Participating children enrolled will engage in intensive CI therapeutic activities along with 30-45 minutes of ArmeoSpring based activities at progressively increasing levels of difficult 6 hday for 5 days a week for three weeks Each childs performance will be tracked and activities will be modified based on performance
Hand function would be assessed using functional hands test AHA Box Blocks test Jebsen Taylor hand function test and TMS at three time points before after and six months after completion of the training protocol
Outcome measures Outcome variables of TMS will be measures of corticomotor excitability using single-pulse TMS Motor evoked potentials MEPs will be recorded via surface electromyography EMG
Significance Understanding how rehabilitation can modulate brain areas associated with motor deficits in CP
Background Children with unilateral cerebral palsy CP tend not to use their impaired arm and hand throughout life This disuse of a limb during postnatal development can stunt the activity-dependent structural and functional development of the motor system Enabling young children to more readily use their affected extremity is likely to increase the competitive ability of the affected side and can improve the functional and anatomical integrity of the motor system
Several studies have shown that applying a restraint to the less affected hand with intensive repetitive use of the more affected hand has significant effect in overcoming learned non-use There is evidence that suggests that CIT produced significant cortical reorganization in adults with chronic and sub-acute cerebrovascular accident CVA and patients with chronic traumatic brain injury and for the lower limb of patients with CVA
The associations between motor physiology and motor performance in children with hemiplegic CP are being examined Recent study shows that children whose impaired hand is controlled by contralateral connections from the unaffected motor cortex show greater improvement to intensive hand training than children whose impaired hand is controlled by ipsilateral connections from the affected motor cortex
In order for future therapies to be applied selectively to brain regions most important in mediating recovery it is important to determine the location of plastic changes produced by intensive practice
Subject Population Children with CP Hemiplegia
Design Participating children enrolled will engage in intensive CI therapeutic activities along with 30-45 minutes of ArmeoSpring based activities at progressively increasing levels of difficult 6 hday for 5 days a week for three weeks Each childs performance will be tracked and activities will be modified based on performance
Hand function would be assessed using functional hands test AHA Box Blocks test Jebsen Taylor hand function test and TMS at three time points before after and six months after completion of the training protocol
Outcome measures Outcome variables of TMS will be measures of corticomotor excitability using single-pulse TMS Motor evoked potentials MEPs will be recorded via surface electromyography EMG
Significance Understanding how rehabilitation can modulate brain areas associated with motor deficits in CP
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