Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerebral Palsy | Other: HABIT-ILE | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Assessor blinded to activities that the participant is working on during camp |
Primary Purpose: | Treatment |
Official Title: | The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP) |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | January 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: 3-Week Camp
Subject will participate in a HABIT-ILE camp format for 6-hours/day, 5 days/week for three weeks.
|
Other: HABIT-ILE
Goal-directed, task-specific training for both the upper (UE) and lower extremity (LE) and postural control.
|
Experimental: 15-Week Camp
Subject will participate in a HABIT-ILE camp format for 6-hours/day, one day/week for 15 weeks.
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Other: HABIT-ILE
Goal-directed, task-specific training for both the upper (UE) and lower extremity (LE) and postural control.
|
Ages Eligible for Study: | 5 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Need to live within commuting distance of Columbia University (NY, NY), Shriners Hospitals for Children-Lexington (Lexington, KY) or Shriners Hospitals for Children-Portland (Portland, OR)
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan Sienko, PhD | 503-221-3481 | ssienko@shrinenet.org | |
Contact: Cathleen Buckon, MS | 503-221-3471 | cbuckon@shrinenet.org |
United States, Kentucky | |
Shriners Hospital for Children Medical Center | Recruiting |
Lexington, Kentucky, United States, 40508 | |
Contact: Donna Oeffinger, PhD 859-268-5627 doeffinger@shrinenet.org | |
Principal Investigator: Donna Oeffinger, PhD | |
United States, New York | |
Teachers College, Columbia University | Recruiting |
New York, New York, United States, 10027 | |
Contact: Andrew Gordon, PhD 212-678-3326 ag275@tc.columbia.edu | |
Principal Investigator: Andrew Gordon, PhD | |
United States, Oregon | |
Shriners Hospitals for Children | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Susan Sienko, PhD 503-221-3481 ssienko@shrinenet.org | |
Contact: Cathleen Buckon,, MS 503-221-3471 cbuckon@shrinenet.org |
Principal Investigator: | Susan Sienko, PhD | Shriners Hospitals for Children-Portland |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 2, 2019 | ||||||||
First Posted Date ICMJE | May 7, 2019 | ||||||||
Last Update Posted Date | September 2, 2020 | ||||||||
Actual Study Start Date ICMJE | April 1, 2019 | ||||||||
Estimated Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP) | ||||||||
Official Title ICMJE | The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP) | ||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Masking Description: Assessor blinded to activities that the participant is working on during camp Primary Purpose: Treatment
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Condition ICMJE | Cerebral Palsy | ||||||||
Intervention ICMJE | Other: HABIT-ILE
Goal-directed, task-specific training for both the upper (UE) and lower extremity (LE) and postural control.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
48 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||
Estimated Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Need to live within commuting distance of Columbia University (NY, NY), Shriners Hospitals for Children-Lexington (Lexington, KY) or Shriners Hospitals for Children-Portland (Portland, OR) Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 5 Years to 17 Years (Child) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03940989 | ||||||||
Other Study ID Numbers ICMJE | 79142 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Susan Sienko, Shriners Hospitals for Children | ||||||||
Study Sponsor ICMJE | Shriners Hospitals for Children | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Shriners Hospitals for Children | ||||||||
Verification Date | August 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |