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

Hemiplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875054
• Other study ID #: 16-00990
• Status: Completed
• Phase: N/A
• First received: August 12, 2016
• Last updated: April 19, 2017
• Start date: June 2016
• Est. completion date: January 1, 2017

Study information

• Verified date: April 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Neurological Injury
• Trauma, Nervous System

Intervention

Behavioral:
• Constraint induced movement therapy (CIMT)
Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity
• Hand-arm bimanual intensive training (HABIT)
Facilitates the translation of gains to improve goal-directed bimanual performance.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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