Back to resultsCamp High 5: Evaluation of the Effect on Upper Limb Function
Primary Purpose
Neurological Injury, Hemiplegia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Constraint induced movement therapy (CIMT)
Hand-arm bimanual intensive training (HABIT)
Sponsored by
About this trial
This is an interventional treatment trial for Neurological Injury
Eligibility Criteria
Inclusion Criteria:
- Participants will range from 2 years to 11 years 11 months of age at time of enrollment. Children under 5 years of age will attend a morning session and children 6 years and older will attend an -Diagnosis: hemiplegia resulting from a neurological Injury
- Manual Ability Classification System or Mini Manual Ability Classification System classification I-III
Exclusion Criteria:
- Botox injection within past 6 months or planned for within 6 months post camp
- Inability to follow commands
- Family unable to commit to daily sessions for 4 weeks
- Unable to tolerate assigned casting protocol (3-24 hours) daily for 4 weeks
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Continued Casting
Intermittent Casting
Arm Description
Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks).
Participants who wear a univalve cast for 3 hours of constraint camp with home exercise program of 2 hours cast wear on the weekends (intermittent casting).
Outcomes
Primary Outcome Measures
Pediatric Motor Activity Log
parent questionnaire to determine how well and how often the family perceives the child Spontaneously uses their affected Upper Extremity throughout the day at home. This assessment is scored by adding up the parental score and getting an average score.
Assisting Hand Assessment
Test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance.
Melbourne-2
Test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions aged 2.5 to 15 years.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02875054
Brief Title
Camp High 5: Evaluation of the Effect on Upper Limb Function
Official Title
Camp High 5 2016: Evaluation of the Effect on Upper Limb Function
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized control trial to evaluate uni-manual and bimanual upper limb function as well as compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (CP) following a hybrid camp model of modified constraint induced movement therapy (mCIMT) and hand-arm bimanual intensive training (HABIT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Injury, Hemiplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continued Casting
Arm Type
Active Comparator
Arm Description
Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks).
Arm Title
Intermittent Casting
Arm Type
Active Comparator
Arm Description
Participants who wear a univalve cast for 3 hours of constraint camp with home exercise program of 2 hours cast wear on the weekends (intermittent casting).
Intervention Type
Behavioral
Intervention Name(s)
Constraint induced movement therapy (CIMT)
Intervention Description
Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity
Intervention Type
Behavioral
Intervention Name(s)
Hand-arm bimanual intensive training (HABIT)
Intervention Description
Facilitates the translation of gains to improve goal-directed bimanual performance.
Primary Outcome Measure Information:
Title
Pediatric Motor Activity Log
Description
parent questionnaire to determine how well and how often the family perceives the child Spontaneously uses their affected Upper Extremity throughout the day at home. This assessment is scored by adding up the parental score and getting an average score.
Time Frame
6 Months
Title
Assisting Hand Assessment
Description
Test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance.
Time Frame
6 Months
Title
Melbourne-2
Description
Test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions aged 2.5 to 15 years.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants will range from 2 years to 11 years 11 months of age at time of enrollment. Children under 5 years of age will attend a morning session and children 6 years and older will attend an -Diagnosis: hemiplegia resulting from a neurological Injury
Manual Ability Classification System or Mini Manual Ability Classification System classification I-III
Exclusion Criteria:
Botox injection within past 6 months or planned for within 6 months post camp
Inability to follow commands
Family unable to commit to daily sessions for 4 weeks
Unable to tolerate assigned casting protocol (3-24 hours) daily for 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renat Sukhov, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Camp High 5: Evaluation of the Effect on Upper Limb Function
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