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

NCT ID: NCT02875054

Last Updated: 2017-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-01-01

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).

Detailed Description

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Conditions

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Neurological Injury Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Continued Casting

Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks).

Group Type ACTIVE_COMPARATOR

Constraint induced movement therapy (CIMT)

Intervention Type BEHAVIORAL

Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity

Hand-arm bimanual intensive training (HABIT)

Intervention Type BEHAVIORAL

Facilitates the translation of gains to improve goal-directed bimanual performance.

Intermittent Casting

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).

Group Type ACTIVE_COMPARATOR

Constraint induced movement therapy (CIMT)

Intervention Type BEHAVIORAL

Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity

Hand-arm bimanual intensive training (HABIT)

Intervention Type BEHAVIORAL

Facilitates the translation of gains to improve goal-directed bimanual performance.

Interventions

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Constraint induced movement therapy (CIMT)

Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity

Intervention Type BEHAVIORAL

Hand-arm bimanual intensive training (HABIT)

Facilitates the translation of gains to improve goal-directed bimanual performance.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renat Sukhov, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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16-00990

Identifier Type: -

Identifier Source: org_study_id

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