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The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP)

A legfontosabb adatok

Hol
New York és Portland (Egyesült Államok)Mind a 2 helyszín megnézése

Helyszínek itt: Egyesült Államok

  • Teachers College, Columbia UniversityNew York, Egyesült ÁllamokNo longer taking part
  • Shriners Hospitals for ChildrenPortland, Egyesült ÁllamokNo longer taking part

A vizsgálat adatai

Ki végzi
Shriners Hospitals for Children
Azonosító
NCT03940989
A regiszteradat frissítve
2024. március 28.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

Kizáró feltételek: Orthopedic surgery in the last year or plans during the study period; Traumatic Brain Injury; Predominate Dystonia; Predominate Athetosis.

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).

ClinicalTrials.gov NCT03940989