Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03940989
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2019-05-02
Brief Title:
The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy BCP
Sponsor:
Shriners Hospitals for Children
Organization:
Shriners Hospitals for Children
Study Overview
Official Title:
The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy BCP
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
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:
A recent systematic review found that therapeutic interventions that apply principles of motor learning with intense practice improve functional upper extremity movement in children with unilateral CP Evidence of efficacy for any treatment approach aimed at improving motor function in bilateral CP the most prevalent form is lacking Preliminary investigation suggests that intensive 90 hours goal-directed task-specific training provided in a 3-week day camp format can improve functional movement of both the upper UE and lower extremity LE and postural control in children with BCP To date HABIT-ILE has only been provided in a day camp setting over several weeks Implementing the dosing schedule of this promising intensive approach in a hospital setting requires innovative resource allocation space and staff thus examining alternative delivery models is imperative The purpose of this study is to conduct a multi-center randomized control trial RCT to determine whether 90 hours of HABIT-ILE improves functional motor skills activity and motivation in children with BCP when dosed in a camp format at 6-hoursday 5 daysweek for three weeks and 6-hoursday one dayweek for 15 weeks
Detailed Description:
Cerebral Palsy CP is the leading cause of childhood motor impairment with 1 in 323 American children affected The resulting impaired motor function in individuals with CP limits their ability to independently perform many functional activities and participate in academic social and leisure activities Children with CP are referred to physical occupational and speech therapy at varying intensities 1-3x week for years depending on individual needs While these therapeutic services are offered regularly the clinical efficacy and optimal dosing parameters are being challenged In a meta-analysis of all available therapeutic interventions for CP just 5 had strong enough evidence to recommend implementation into clinical practice for children with unilateral CP Novak et al 2013 and no therapies had sufficient evidence of efficacy for treatment of upper UE or lower extremities LE in children with bilateral CP BCP The key features of interventions with proven evidence of clinical efficacy include a motor learning approach involving active movement an environment to shape desired movements and a much higher treatment intensity than provided in weekly therapies Despite BCP being the most prevalent subtype the majority of the research evaluating the clinical efficacy and dosing parameters of therapeutic interventions has been determined in children with UCP with upper extremity approaches such as Constraint Induced Movement Therapy CIMT and Hand-Arm Bimanual Intensive Therapy HABIT demonstrating efficacy
One promising therapy gaining interest and support for children with BCP is Hand-Arm Bimanual Intensive Therapy Including the Lower Extremities HABIT-ILE HABIT-ILE aims to improve upper and lower movement control by engaging the UE and LE during combined activities for many hours every day for 3 weeks Preliminary investigation has demonstrated that children with BCP participating in a 90-hour HABIT-ILE day camp achieve improvement within the body function and structure activity and participation levels of the International Classification of Functioning Disability and Health ICF While intensive therapies such as HABIT-ILE are typically provided in a day camp setting over several weeks implementing the dosing schedule of this promising intensive approach in a hospital setting requires innovative resource allocation space and staff In order to establish the efficacy of this approach for children with BCP it is essential to further examine the efficacy of the 3-week HABIT-ILE camp format of delivery in a larger multisite trial in addition to examining whether an alternative model of intensity and resource allocation can demonstrate similar efficacy The overall aim of the proposed work is to determine the effectiveness of two different dosing schedules of an intensive therapeutic intervention that applies motor learning to upper and lower extremity movement and postural control to improve functional motor skills activity and self-mastery in children with BCP The specific aims are
Specific Aim 1 To determine if there are significant gains and retention in functional motor skills activity and self-mastery in children with BCP receiving 90 hours of HABIT-ILE dosed in a camp format for 6-hours per day 5 days per week for three weeks and for 6-hours a day one day per week for 15 weeks
Specific Aim 2 To determine whether the degree of involvement age and self-mastery predict the magnitude and maintenance of change seen in children with BCP receiving 90 hours of HABIT-ILE dosed in a camp format for 6-hours per day 5 days per week for three weeks and for 6-hours a day one day per week for 15 weeks
One promising therapy gaining interest and support for children with BCP is Hand-Arm Bimanual Intensive Therapy Including the Lower Extremities HABIT-ILE HABIT-ILE aims to improve upper and lower movement control by engaging the UE and LE during combined activities for many hours every day for 3 weeks Preliminary investigation has demonstrated that children with BCP participating in a 90-hour HABIT-ILE day camp achieve improvement within the body function and structure activity and participation levels of the International Classification of Functioning Disability and Health ICF While intensive therapies such as HABIT-ILE are typically provided in a day camp setting over several weeks implementing the dosing schedule of this promising intensive approach in a hospital setting requires innovative resource allocation space and staff In order to establish the efficacy of this approach for children with BCP it is essential to further examine the efficacy of the 3-week HABIT-ILE camp format of delivery in a larger multisite trial in addition to examining whether an alternative model of intensity and resource allocation can demonstrate similar efficacy The overall aim of the proposed work is to determine the effectiveness of two different dosing schedules of an intensive therapeutic intervention that applies motor learning to upper and lower extremity movement and postural control to improve functional motor skills activity and self-mastery in children with BCP The specific aims are
Specific Aim 1 To determine if there are significant gains and retention in functional motor skills activity and self-mastery in children with BCP receiving 90 hours of HABIT-ILE dosed in a camp format for 6-hours per day 5 days per week for three weeks and for 6-hours a day one day per week for 15 weeks
Specific Aim 2 To determine whether the degree of involvement age and self-mastery predict the magnitude and maintenance of change seen in children with BCP receiving 90 hours of HABIT-ILE dosed in a camp format for 6-hours per day 5 days per week for three weeks and for 6-hours a day one day per week for 15 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None