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Completed

NCT Number: NCT04816175

Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay

This trial will consist of a clinical series of up to 50 children with Global Developmental Delay and concomitant microcephaly or hyperkinetic movements. All children will be assessed for psychomotor function using standardized assessments, goal specific assessments, with the potential addition of neuroimaging assessment, prior to and after receiving an intensive burst of neuromotor therapy. The interventional effects will be explored by comparing the pre and post interventional assessments and neuroimaging.

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Key information

Conditions

Microcephaly Communication Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dyskinesias Global Developmental Delay Hyperkinesis Hyperkinesis With Developmental Delay Learning Disabilities Malformations of Cortical Development Malformations of Cortical Development, Group I Mental Disorders Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Nervous System Malformations Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at Virginia Tech

Roanoke, Virginia, 24016, United States

About this study

Up to 50 children between the ages of 6 months and 15 years will be recruited to participate in a burst of intensive neuromotor intervention in the form of Acquire therapy, delivered by the treatment team at Virginia Tech's Neuromotor Research Clinic. All children will have a diagnosis of Global Developmental Delay, with concomitant microcephaly or hyperkinetic movements. The children will be assessed for psychomotor function prior to and after the treatment intervention, using a series of standardized and goal specific assessments, with the possibility of additional neuroimaging assessments when possible. Acquire therapy is an intensive intervention in that it is delivered with high intensity, wherein goal directed behaviors are promoted at high levels of repetition and delivered at a high dose (4-6 hours a day) in an intensive burst of 3-4 weeks of 5 day a week treatment. Acquire therapy is an operant conditioning based intervention delivered in a cycle of refinement, reinforcement and repetition. It is play-based with activities selected to drive behavior toward goals that are specific to each child and selected based on each child's interests and needs. As such a specific protocol cannot be outlined. However, all goal directed activities are designed to promote awareness of and engagement with others and the environment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Global Developmental Delay with Microcephaly or hyperkinetic movements.

Exclusion criteria

  • Medical Instability
  • Under 6 months of age over 15 years of age

Treatment and study plan

Acquire Therapy

Behavioral

This intervention is an operant conditioning based neurorehabilitation protocol for the promotion of psychomotor function

Primary outcomes

  1. Change from baseline on Motor Function Assessment

    Time frame: 5-12 weeks

    A validated motor function assessment tool the CanChild Gross Motor Function Measure -88 will be used to measure change on motor function. The child can score between 0 and 264 points. The higher the child's score the more tasks they were able to attempt and/or complete.

Secondary outcomes

  1. Change from baseline on measure of EEG coherence in alpha band

    Time frame: 5-12 weeks

    EEG data will be analyzed for changes in coherence in alpha band. Pre and post coherence in alpha band will be probed for changes by electrode pair.

  2. Change from baseline on measure of EEG coherence in theta band.

    Time frame: 5-12 weeks

    EEG data will be analyzed for changes in coherence in theta band. Pre and post coherence in theta band will be probed for changes by electrode pair.

  3. Change from baseline on measure of EEG coherence in beta band.

    Time frame: 5-12 weeks

    EEG data will be analyzed for changes in coherence in beta band. Pre and post coherence in beta band will be probed for changes by electrode pair.

  4. Change from baseline on measure of EEG coherence in delta band.

    Time frame: 5-12 weeks

    EEG data will be analyzed for changes in coherence in delta band. Pre and post coherence in delta band will be probed for changes by electrode pair.

  5. Change from baseline on EEG power in alpha band.

    Time frame: 5-12 weeks

    EEG data will be analyzed for changes in power in alpha band. Pre and post power will be compared for alpha band.

  6. Change from baseline on EEG power in beta band.

    Time frame: 5-12 weeks

    EEG data will be analyzed for changes in power in beta bands. Pre and post power will be compared for beta band.

  7. Change from baseline on EEG power in theta band.

    Time frame: 5-12 weeks

    EEG data will be analyzed for changes in power in theta band. Pre and post power will be compared for theta band.

  8. Change from baseline on EEG power in delta bands.

    Time frame: 5-12 weeks

    EEG data will be analyzed for changes in power in delta bands. Pre and post power will be compared for delta band.

  9. Change from baseline on Disability Assessment

    Time frame: 5-12 weeks

    Using the Pediatric evaluation of disability inventory with scores ranging from 0-100 with higher scored indicating greater functionality.

  10. Change from baseline on fMRI measures of connectivity

    Time frame: 5-12 weeks

    fMRI data will be probed for change from baseline on measures of connectivity.

  11. Change from baseline on fMRI regional activation patterns.

    Time frame: 5-12 weeks

    fMRI data will be probed for change from baseline on measures of regional activation.

  12. Change from baseline on Motor Assessment

    Time frame: 5-12 weeks

    Using the Peabody Developmental Motor Scales, the Peabody consists of 6 subtests, that are each completed according to the child's age as a starting point. If a child were to complete all 6 subtests, and were to start at the earliest age block for all subtests the child would complete 255 items, with scores ranging from 0-510, the higher the score the more tasks the child was able to complete.

  13. Change from baseline on goal specific assessment

    Time frame: 5-12 weeks

    Using a goal specific assessment form developed in the neuromotor research clinic children will be assessed for changes on child specific goals using a metric goal attainment assessment method (See Mann, J 2020 Dev Neurorehab). The child will be measured on their percent change on child-specific goals, with ranges from 0 percent change to infinity percent change. The higher the percent change the more the child changed on that particular goal.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • American Academy of Cerebral Palsy and Developmental Medicine

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 25, 2021
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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