Early Childhood Constraint Therapy in Cerebral Palsy (APPLES)
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|ClinicalTrials.gov Identifier: NCT02567630|
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Behavioral: Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy||Not Applicable|
Cerebral palsy (CP) is the most common physical disability in childhood.1 It affects 3.6/100 children in the US2 with ~10,000 new diagnoses every year. The prevalence of CP in developing countries is estimated to be ~5-10 times greater. CP is a disorder resulting from sensory and motor impairments due to perinatal brain injury, with lifetime consequences that range from poor adaptive and social function to communication and emotional disturbances,9 all contributing to a shortened life expectancy. The societal costs are difficult to estimate but the financial burden is well over $1 M per life affected. A growing number of evidence-based therapies aim to improve gross motor function through changes in body structures and function in children with CP (e.g. hip surveillance, surgery). However, infants with CP have a fundamental disadvantage in recovering motor function: they do not receive accurate sensory feedback from their movements, leading to neglect of an affected extremity and difficulty learning new movements, a process called developmental disregard (DD). As a consequence, even children who receive time- and resource-intensive standard therapies have stable or declining motor function and developmental trajectories that do not "catch up" to those of typically developing children. DD can then lead to school-age learning problems, decreased participation in physical and social activities and costly long-term mental and physical morbidities.
Constraint-Induced Movement Therapy (CIMT) is one of the few effective neurorehabilitative strategies shown to improve upper extremity motor function in adults and older children with CP, potentially overcoming developmental disregard. It is mainly applicable to CP patients who are diagnosed with asymmetric or hemiparetic forms of the disorder, in which one side of the body is more affected than the other. CIMT is based on the premise that preferential use of an affected upper extremity (by constraining the less affected one), and shaping with repetition of movement by skilled therapists, can overcome neglect and restore function of that extremity.
The investigators are conducting a randomized trial of CIMT in children with CP using a wait-list control group. This design allows every child with CP to eventually receive the treatment and avoids issues of equipoise. The RCT portion of the study extends only for a 7-month period, from baseline to 6 months after the 1-month CIMT ends. For CP wait-listed controls, the study continues for 6 months following the CMIT intervention, separate from the completed RCT. We will reference data from both groups to a cohort of typically developing (TD) children to determine developmental trajectories.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||145 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Early Childhood Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy|
|Actual Study Start Date :||October 5, 2015|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2020|
- Behavioral: Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy
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.
- Kinematics of reach [ Time Frame: Change from Baseline to Post intervention (1 month), and 6 months later ]
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.
- Somatosensory processing measurement by ERP [ Time Frame: Change from Baseline to Post intervention (1 month), and 6 months later ]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.
- Bayley Scales of Infant and Toddler Development (Bayley III) — 3rd Edition [ Time Frame: Change from Baseline to Post intervention (1 month), and 6 months later ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567630
|Contact: Stephanie Burkhardt, MPH||614-722-4883||Stephanie.Burkhardt@nationwidechildrens.org|
|United States, Ohio|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Nathalie L Maitre, MD, PHD 614-722-4428 Nathalie.Matire@nationwidechildrens.org|
|Contact: Stephanie Burkhardt, MPH 614-722-4883 Stephanie.Burkhardt@nationwidechildrens.org|
|Principal Investigator: Nathalie L Maitre, MD,PHD|
|Principal Investigator:||Nathalie L Maitre, MD, PhD||Nationwide Childrens hospital|