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Behavioural Intervention

Intensive Motor Learning Intervention for Cerebral Palsy

N/A
Waitlist Available
Led By Susan Sienko, PhD
Research Sponsored by Shriners Hospitals for Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to get up from a chair with standby assist
Diagnosis of Bilateral Cerebral Palsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial will test if an intensive motor learning intervention can improve movement in children with bilateral CP when delivered in a hospital setting.

Who is the study for?
This trial is for children with Bilateral Cerebral Palsy (BCP), GMFCS levels II-IV, who can follow directions and speak English. They should be able to perform certain physical tasks like getting up from a chair with help and walking 10 steps with or without assistance. Participants need to live near specific locations in NY, SC, or OR and agree not to use Botox/Dysport for 3 months before assessments.Check my eligibility
What is being tested?
The study tests HABIT-ILE, an intensive training aimed at improving motor skills in kids with BCP. It's a randomized control trial comparing two dosing schedules: a 'camp' format of 6 hours/day for three weeks versus the same total hours spread over one day/week for fifteen weeks.See study design
What are the potential side effects?
Since this intervention involves physical therapy rather than medication, side effects may include muscle soreness, fatigue, or frustration during the learning process. However, these are generally mild and temporary as part of rehabilitation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can stand up from a chair with some help.
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I have been diagnosed with Bilateral Cerebral Palsy.
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My mobility is somewhat to very limited due to my condition.
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I agree not to use Botox/Dysport for 3 months before my major check-ups.
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I can walk 10 steps on my own or with help.
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I can sit up with support for my arms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Gross Motor Function Measure (GMFM)
Change in Jebsen-Taylor Test of Hand Function
Change in Pediatric Balance Scale
+1 more
Secondary outcome measures
Change in 2-minute walk
Change in ABILHAND
Change in ABILOCO
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: 3-Week CampExperimental Treatment1 Intervention
Subject will participate in a HABIT-ILE camp format for 6-hours/day, 5 days/week for three weeks.
Group II: 15-Week CampExperimental Treatment1 Intervention
Subject will participate in a HABIT-ILE camp format for 6-hours/day, one day/week for 15 weeks.

Find a Location

Who is running the clinical trial?

Shriners Hospitals for ChildrenLead Sponsor
97 Previous Clinical Trials
23,925 Total Patients Enrolled
12 Trials studying Cerebral Palsy
654 Patients Enrolled for Cerebral Palsy
Teachers College, Columbia UniversityOTHER
24 Previous Clinical Trials
5,818 Total Patients Enrolled
6 Trials studying Cerebral Palsy
334 Patients Enrolled for Cerebral Palsy
Susan Sienko, PhDPrincipal Investigator - Shriners Hospitals for Children-Portland
Shriners Hospitals for Children

Media Library

HABIT-ILE (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03940989 — N/A
Cerebral Palsy Research Study Groups: 3-Week Camp, 15-Week Camp
Cerebral Palsy Clinical Trial 2023: HABIT-ILE Highlights & Side Effects. Trial Name: NCT03940989 — N/A
HABIT-ILE (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03940989 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants for this trial limited to adults over 18 years of age?

"Patients aged between 5 and 17 can participate in this medical experiment."

Answered by AI

Are there vacancies available in this clinical trial?

"That is correct. According to information available on clinicaltrials.gov, this medical trial was first posted on April 1st 2019 and has been actively seeking patients since then - with the latest update being June 10th 2022. The study requires 48 participants located across 4 sites."

Answered by AI

In which regions is this research accessible?

"Currently, this clinical trial is enrolling patients from 4 different cities; New york City, Greenville, Portland and a quartet of other locations. To reduce the burden on participants during travel to appointments it's recommended that applicants select the site nearest them for enrolment."

Answered by AI

What is the scope of this research project in terms of participants?

"To proceed with this medical trial, 48 suitable patients must be recruited. Those interested can look into enrolling at Teachers College, Columbia University in New york or Shriners Hospitals for Children in Greenville, South carolina."

Answered by AI

What is the primary aim of this medical experiment?

"This medical trial's primary outcome will be monitored by the Change in Trunk Control Measurement Scale. Secondary objectives include assessing changes in Box and Blocks, Dimensions of Mastery Questionnaire, and ABILOCO-Kids (a 10-item parent-report measure of locomotor ability for children with lower limb impairments)."

Answered by AI

Are there any eligibility criteria for participants in this clinical experiment?

"The study is seeking 48 individuals aged 5 to 17 with cerebral palsy who reside in close proximity of Columbia University, Shriners Hospitals for Children-Greenville, or Shriners Hospitals for Children-Portland. Additionally, participants must fall into Gross Motor Function Classification System (GMFCS) levels II - IV and demonstrate the ability to rise from a chair using standby assist, sit on a mat table utilizing upper extremity support, comprehend directions given by staff as well as walk 10 steps aided/unassisted and with standby assistance. The applicants should also accept a 3 month restriction on Botox/Dysport use prior to"

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Shriners Hospitals for Children
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP)
Susan Sienko 2019. "The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy (BCP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03940989.
~6 spots leftby Apr 2025
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