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

Not Applicable

Completed

• Conditions: Hemiplegia; Neurological Injury
• Interventions: Behavioral: Constraint induced movement therapy (CIMT); Behavioral: Hand-arm bimanual intensive training (HABIT)

• Registration Number: NCT02875054
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-23
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Casting	Constraint induced movement therapy (CIMT)	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).
Continued Casting	Constraint induced movement therapy (CIMT)	Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks).
Continued Casting	Hand-arm bimanual intensive training (HABIT)	Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks).
Intermittent Casting	Hand-arm bimanual intensive training (HABIT)	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).

Primary Outcome Measures

Name	Time	Method
Assisting Hand Assessment	6 Months	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	6 Months	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.
Pediatric Motor Activity Log	6 Months	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States