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Trial record 97 of 214 for:    Cerebral Palsy | United States

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

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ClinicalTrials.gov Identifier: NCT03940989
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Teachers College, Columbia University
University of Kentucky
Information provided by (Responsible Party):
Susan Sienko, Shriners Hospitals for Children

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: HABIT-ILE Not Applicable

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 : 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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Gross Motor Function Measure (GMFM) [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    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.

  2. Change in Jebsen-Taylor Test of Hand Function [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    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. Change in Pediatric Balance Scale [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    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.

  4. Change in Trunk Control Measurement Scale [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    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.


Secondary Outcome Measures :
  1. Change in Box and Blocks [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    Grasping, transporting and releasing blocks. The test is performed three times for each hand and the mean number of blocks transferred in a minute from the trials will be used to assess gains in manual dexterity.

  2. Change in 2-minute walk [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    The total distance walked in 2 minutes will be used to assess changes in mobility.

  3. Change in ABILOCO [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    The ABILOCO-kids is a 10-item parent-report measure of locomotor ability for children with lower limb impairments. The items represent continuous progression in difficulty of the locomotor activity.

  4. Change in ABILHAND [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    The ABILHAND-kids is a 21-item parent-report measure of bimanual activity for children with CP. The bimanual activities demonstrate continuous progression in difficulty. Higher scores indicate greater ability.

  5. Change in Pediatric Evaluation of Disability Inventory (PEDI-CAT) [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    Parent questionnaire to assess both capability and performance of functional activities in self-care, mobility, and social function. Each of the three scales will be assessed separately to determine whether specific functional activity areas change with intervention. Higher scores indicate a higher functional level.

  6. Change in Dimensions of Mastery Questionnaire [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    The 45-item parent-report questionnaire assesses two elements of mastery motivation: instrumental (persistence at object-related tasks, social activities with adults, social interactions with peers, and gross motor tasks) and expressive (behavioral indicators of positive affect during or following tasks and negative reaction to failure). Subscale scores will be used to determine whether motivation impacts gains in functional motor skills and whether gains in functional motor skills impact the magnitude of motivation.

  7. Change in Canadian Occupational Performance Measure (COPM) [ Time Frame: One assessment at Baseline 2 will be used to define goals. Two end of study evaluations (EOS) one the week after completion of camp and a 6-month followup ]
    Semi-structured interview that enables and open dialogue between the patient/parent on issues of importance to the patient/parent. The COPM is an individualized measure designed to detect change in a child's self-reported occupational performance over time. Occupations are classified into three categories: self-care, productivity and leisure.

  8. Change in Functional and quantitative muscle strength [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    Measurement of muscle strength.Quantitative strength of the abductors, knee extensors, and ankle plantarflexors will be measured with a hand-held dynamometer. Functional assessments of standing heel rise, sit to stand and lateral steps ups will assess functional strength. Higher numbers indicate greater strength.

  9. Change in Community Participation [ Time Frame: 4 Assessments: Baseline 1 will be group dependent (15 weeks or 3 weeks prior to camp) Baseline 2 will be at start of camp. Two end of study evaluations: one the week following completion of camp and one at 6-months followup ]
    FitBits will be used to examine activity within the community. The mean number of steps per day within the time period will be used to assess change in community activity.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940989


Contacts
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Contact: Susan Sienko, PhD 503-221-3481 ssienko@shrinenet.org
Contact: Cathleen Buckon, MS 503-221-3471 cbuckon@shrinenet.org

Locations
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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   
Sponsors and Collaborators
Shriners Hospitals for Children
Teachers College, Columbia University
University of Kentucky
Investigators
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Principal Investigator: Susan Sienko, PhD Shriners Hospitals for Children-Portland
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Responsible Party: Susan Sienko, Research Associate, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT03940989    
Other Study ID Numbers: 79142
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases