Early Childhood Constraint Therapy in Cerebral Palsy

NCT02567630 | Unknown DMC

• 1 other identifier: IRB15-00547
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective interventional study involving young children who will all receive non-invasive, passive assessments of sensory and motor function. In addition a subpopulation of young children with cerebral palsy will participate in a randomized controlled trial of constraint-induced movement therapy, a routinely prescribed therapy used in clinical practice for children with motor difficulties. The study attempts to apply a rigorous scientific approach to study a widely used but poorly studied practice. The design is an RCT with wait-list controls to allow all children to benefit from the therapy, even if they are randomized to the control group. All children, regardless of group allocation will continue with their standard of care occupational and physical therapy throughout the study.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• Kinematics of reach

  We will use a motion analysis system tracks reflective markers at a rate of 240 Hz with spatial precision at the 1-mm level to capture movement in three-dimensional space. Markers will be positioned bilaterally on the head of the second metacarpal bone and on the object. Tracker software will be used to determine the three-dimensional position of the hand as it approaches each object, and to construct segments, angles and moments using Matlab software. For each trial, approach velocity and movement units (marked by changes in speed or position) will be calculated. A single movement unit is defined as the portion of reach between one acceleration and another. The sum composite of movement units in one reach attempt is defined as smoothness. The motion tracking data will also be used to determine the time from presentation to first contact, time from first contact to grasp and approach velocity on the unilateral task.

  Change from Baseline to Post intervention (1 month), and 6 months later

• Somatosensory processing measurement by ERP

  A high-density array of 128 electrodes embedded in soft sponges (Geodesic Sensor Net, EGI, Inc., Eugene, OR) will be used to record ERPs with a sampling rate of 1000 Hz, filters set to 0.1-400 Hz. All electrodes will be referred to Cz and re-referenced offline to an average reference. Recording of brainwaves will be controlled by Net Station (v. 4.3; EGI, Inc., Eugene, OR). E-Prime (v. 2.0, PST, Inc., Pittsburgh, PA) software will control stimulus delivery. Air puffs will be delivered using a custom-made apparatus with two flexible nozzles, one positioned approximately 0.5" below the palm of hand secured in a molded soft holder (puff condition), the other placed in proximity but directed away (sham condition). The pressure at the skin surface is 5 psi, or less than the pressure of the smallest microfilament used to test for neuropathies. For each hand, 60 puffs will be presented randomly interspersed with 60 sham trials.

  Change from Baseline to Post intervention (1 month), and 6 months later

• Bayley Scales of Infant and Toddler Development (Bayley III) - 3rd Edition

  The Bayley III is the gold standard for the evaluation of former NICU graduates, and we have extensive experience using it in the Follow-Up Clinic. The motor scales provide a developmental and functional assessment, address unimanual as well as bimanual skills, are normed against a large population and designed to be adjusted for varying degrees of prematurity. The Bayley fine motor items for 6-24 months (score range: 0-42) measure prehension, motor planning, grasping patterns, and eye-hand coordination. The examiner is masked to intervention vs. control group membership and administers the fine motor subscale twice, repeating unilateral items for right and left hands. Most (about 80%) of the Bayley fine motor items for infants aged 6 to 24 months require unilateral reach and grasp. In addition to standard testing, separate scores will be obtained to characterize the difference between more and less affected extremity.

  Change from Baseline to Post intervention (1 month), and 6 months later

Interventions

Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy BEHAVIORAL

The CIMT intervention includes 3 components: (1) placement of a removable soft constraint for ½ each day, with a non-invasive wear monitor (2) demonstration and prescribed home-use of a sensory kit (3) and a reach/grasp tool. The intervention lasts 4 weeks as has been published in older children as well as used in infant trial descriptions.

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

• Maitre NL, Jeanvoine A, Yoder PJ, Key AP, Slaughter JC, Carey H, Needham A, Murray MM, Heathcock J; BBOP group. Kinematic and Somatosensory Gains in Infants with Cerebral Palsy After a Multi-Component Upper-Extremity Intervention: A Randomized Controlled Trial. Brain Topogr. 2020 Nov;33(6):751-766. doi: 10.1007/s10548-020-00790-5. Epub 2020 Aug 3.

  PMID: 32748303 DERIVED

• Chorna O, Heathcock J, Key A, Noritz G, Carey H, Hamm E, Nelin MA, Murray M, Needham A, Slaughter JC, Maitre NL. Early childhood constraint therapy for sensory/motor impairment in cerebral palsy: a randomised clinical trial protocol. BMJ Open. 2015 Dec 7;5(12):e010212. doi: 10.1136/bmjopen-2015-010212.

  PMID: 26644127 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nathalie L Maitre, MD, PhD

  Nationwide Childrens hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director NICU follow up program

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: October 5, 2015
• Study Start: October 5, 2015
• Primary Completion: January 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

US (1)