Camp High 5: Evaluation of the Effect on Upper Limb Function

Study Overview
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Brief Summary
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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).

Official Title
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Camp High 5 2016: Evaluation of the Effect on Upper Limb Function

Conditions
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Neurological Injury, Hemiplegia

Intervention / Treatment
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* Behavioral: Constraint induced movement therapy (CIMT)
* Behavioral: Hand-arm bimanual intensive training (HABIT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continued Casting<br>Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks). | Behavioral: Constraint induced movement therapy (CIMT)<br>* Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity<br>Behavioral: Hand-arm bimanual intensive training (HABIT)<br>* Facilitates the translation of gains to improve goal-directed bimanual performance.<br>|
| Active Comparator: Intermittent Casting<br>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). | Behavioral: Constraint induced movement therapy (CIMT)<br>* Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity<br>Behavioral: Hand-arm bimanual intensive training (HABIT)<br>* Facilitates the translation of gains to improve goal-directed bimanual performance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 Months | 
| 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. | 6 Months | 
| 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. | 6 Months |