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

NCT ID: NCT04816175

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2022-08-11

Brief Summary

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.

Detailed Description

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.

Conditions

Microcephaly; Hyperkinesis With Developmental Delay; Global Developmental Delay

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Intervention

All children will receive 3-5 weeks of intensive neuromotor Acquire therapy, an operant conditioning, play based therapy that maximizes therapeutic movements, attention, and engagement.

Group Type: EXPERIMENTAL

Acquire Therapy

Intervention Type: BEHAVIORAL

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

Interventions

Acquire Therapy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Cerebral Palsy and Developmental Medicine

OTHER

Sponsor Role: collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie DeLuca

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie C DeLuca, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

Fralin Biomedical Research Institute at Virginia Tech

Roanoke, Virginia, United States

Countries

United States

References

DeLuca SC, Wallace DA, Trucks MR, Mukherjee K. A clinical series using intensive neurorehabilitation to promote functional motor and cognitive skills in three girls with CASK mutation. BMC Res Notes. 2017 Dec 19;10(1):743. doi: 10.1186/s13104-017-3065-z.

Reference Type: BACKGROUND

PMID: 29258560 (View on PubMed)

Mann J, Wallace DA, DeLuca S. Case study on the use of intensive pediatric neurorehabilitation in the treatment of kernicterus. J Clin Mov Disord. 2020 Feb 3;7:1. doi: 10.1186/s40734-020-0084-z. eCollection 2020.

Reference Type: BACKGROUND

PMID: 32042435 (View on PubMed)

Ramey SL, DeLuca S, Stevenson RD, Case-Smith J, Darragh A, Conaway M. Children with Hemiparesis Arm and Movement Project (CHAMP): protocol for a multisite comparative efficacy trial of paediatric constraint-induced movement therapy (CIMT) testing effects of dosage and type of constraint for children with hemiparetic cerebral palsy. BMJ Open. 2019 Jan 15;9(1):e023285. doi: 10.1136/bmjopen-2018-023285.

Reference Type: BACKGROUND

PMID: 30782701 (View on PubMed)

Other Identifiers

IRB #18-490

Identifier Type: -

Identifier Source: org_study_id