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

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT02875054

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Neurological Injury Hemiplegia	Behavioral: Constraint induced movement therapy (CIMT) Behavioral: Hand-arm bimanual intensive training (HABIT)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT02875054

Other Study ID Numbers:

16-00990

First Posted:

Aug 23, 2016

Last Update Posted:

Apr 21, 2017

Last Verified:

Apr 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemiplegia

Trauma, Nervous System

Study Results

No Results Posted as of Apr 21, 2017