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

NCT03940989 | Completed

• 1 other identifier: 79142
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (4)

• Change in Gross Motor Function Measure (GMFM)

  Objective assessment of crawling, kneeling, standing, walking, running, jumping.The GMFM is scored on a 4-point scale ranging from does not initiate (0) to completes (3). Each dimension is scored independently providing a measure of functional motor ability within the dimension.

  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

• Change in Jebsen-Taylor Test of Hand Function

  Objective test of hand function for activities of daily living. Scoring is based on time to perform the individual tasks and times are compared to normative tables with assessment by age and gender.

  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

• Change in Pediatric Balance Scale

  Assessment of Standing Balance. THE PBS is a 14 item performance based balance test which is scored on a 5-point scale ranging from a low of 0 to a maximum of 4, with a maximum score of 56.

  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

• Change in Trunk Control Measurement Scale

  The TCMS assesses trunk control during both static and dynamic sitting balance. Dynamic sitting is further divided into selective movement control and dynamic reaching. Higher scores indicate greater balance.

  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 (8)

• Change in Box and Blocks

  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

• Change in 2-minute walk

  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

• Change in ABILOCO

  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

• Change in ABILHAND

  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

• Change in Pediatric Evaluation of Disability Inventory (PEDI-CAT)

  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

Study Arms (2)

3-Week Camp

EXPERIMENTAL

Subject will participate in a HABIT-ILE camp format for 6-hours/day, 5 days/week for three weeks.

Other: HABIT-ILE

15-Week Camp

EXPERIMENTAL

Subject will participate in a HABIT-ILE camp format for 6-hours/day, one day/week for 15 weeks.

Other: HABIT-ILE

Interventions

HABIT-ILE OTHER

Goal-directed, task-specific training for both the upper (UE) and lower extremity (LE) and postural control.

15-Week Camp; 3-Week Camp

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shriners Hospitals for Children: lead
• Teachers College, Columbia University: collaborator

Study Sites (2)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

Shriners Hospitals for Children

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Susan Sienko, PhD

  Shriners Hospitals for Children-Portland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor blinded to activities that the participant is working on during camp
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 7, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)