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

NCT02875054 | Completed

• 1 other identifier: 16-00990
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Neurological Injury; Hemiplegia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Continued Casting

ACTIVE COMPARATOR

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); Behavioral: Hand-arm bimanual intensive training (HABIT)

Intermittent Casting

ACTIVE COMPARATOR

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); Behavioral: Hand-arm bimanual intensive training (HABIT)

Interventions

Constraint induced movement therapy (CIMT) BEHAVIORAL

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

Continued Casting; Intermittent Casting

Hand-arm bimanual intensive training (HABIT) BEHAVIORAL

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

Continued Casting; Intermittent Casting

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Trauma, Nervous System; Hemiplegia

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Renat Sukhov, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 23, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

US (1)