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

April 19, 2017 updated by: NYU Langone Health

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continued Casting
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)
Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity
Behavioral: Hand-arm bimanual intensive training (HABIT)
Facilitates the translation of gains to improve goal-directed bimanual performance.
Active Comparator: 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).
Behavioral: Constraint induced movement therapy (CIMT)
Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity
Behavioral: Hand-arm bimanual intensive training (HABIT)
Facilitates the translation of gains to improve goal-directed bimanual performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Motor Activity Log
Time Frame: 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.
6 Months
Assisting Hand Assessment
Time Frame: 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.
6 Months
Melbourne-2
Time Frame: 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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Renat Sukhov, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-00990

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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