Clinical trial NCT03940989: The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP)
Official title: The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
Collaborators: name: Teachers College, Columbia University
First posted: 2019-05-07
Enrollment: 39
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-hours/day, 5 days/week for three weeks and 6-hours/day, one day/week 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.

Eligibility criteria: Need to live within commuting distance of Columbia University (NY, NY), Shriners Hospitals for Children-Greenville (Greenville, SC) or Shriners Hospitals for Children-Portland (Portland, OR)

Inclusion Criteria:

* Diagnosis of Bilateral Cerebral Palsy
* Gross Motor Function Classification System (GMFCS) levels II-IV
* Able to get up from a chair with standby assist
* Able to sit on a mat table with upper extremity support
* Ability to understand directions
* Ability to walk 10 steps with/without assistive device and standby assist
* Ability to understand and speak english
* Willing to restrict Botox/Dysport use for 3 months prior to each of the 4 full assessments
* Willing to be randomized to either camp format

Exclusion Criteria:

* Traumatic Brain Injury
* Predominate Dystonia
* Predominate Athetosis
* Orthopedic surgery in the last year or plans during the study period

Primary outcomes:
measure: Change in Gross Motor Function Measure (GMFM)
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
measure: Change in Jebsen-Taylor Test of Hand Function
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
measure: Change in Pediatric Balance Scale
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
measure: Change in Trunk Control Measurement Scale
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Secondary outcomes:
measure: Change in Box and Blocks
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
measure: Change in 2-minute walk
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
measure: Change in ABILOCO
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
measure: Change in ABILHAND
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
measure: Change in Pediatric Evaluation of Disability Inventory (PEDI-CAT)
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
measure: Change in Dimensions of Mastery Questionnaire
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
measure: Change in Canadian Occupational Performance Measure (COPM)
timeFrame: One assessment at Baseline will be used to define goals. Two end of study evaluations (EOS) one the week after completion of camp and a 6-month followup
measure: Change in Functional and quantitative muscle strength
timeFrame: 3 Assessments: Baseline will be just before the start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
city: Portland
country: United States
facility: Shriners Hospitals for Children
state: Oregon
Study officials:
affiliation: Shriners Hospitals for Children-Portland
name: Susan Sienko, PhD
role: PRINCIPAL_INVESTIGATOR
References: