Clinical trial NCT03325946: The FBRI VTC Neuromotor Research Clinic
Official title: The FBRI VTC Neuromotor Research Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromotor Impairments
Cerebral Palsy
Microcephaly
Autism
Trauma, Brain
Acquired Brain Injury
Pediatric Stroke
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 500
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with neuromotor impairment who want to try and gain motor skills and function

Brief summary: The FBRI VTC Neuromotor Research Clinic was established and opened in May of 2013 to provide intensive therapeutic services to individuals with motor impairment secondary to neuromotor disorders. It is direct by Dr. Stephanie DeLuca and based on the principles surrounding ACQUIREc Therapy.

ACQUIREc Therapy is an evidenced-based approach to pediatric constraint-induced movement therapy, which refers to a multi-component form of therapy that is focused on helping children who have asymmetric motor abilities between the two sides of the body. Historically, ACQUIREc Therapy has the unimpaired or less impaired upper extremity constrained (by a cast or a splint) while also receiving active therapy from a specially trained therapist who shapes new skills and functional activities with the child's more impaired upper extremity but who is also a licensed Occupational or Physical Therapist (OT/PT). Therapy dosages are high much higher than tradition OT or PT - often lasting many hours per day, up to 6 hours a day, 5 days a week, for 2-4 weeks.

Investigators have developed further treatments based on the same principles of intensive services combined with behavior shaping for other areas of the body that are also affected by weakness (e.g., the leg and trunk) also, but which usually do not involve constraint. These have been more generally labeled ACQUIRE Therapy.

All forms involve intensive, play-based therapy for children with asymmetric motor impairments of the arms and hands. The primary focus of treatment is to facilitate the acquisition of new motor skills in the child's weaker body parts through high levels of intensive therapy using scientifically-based behavioral guidelines. Therapy is also delivered in naturalistic environments.

ACQUIREc Therapy as a treatment method has been tested in two randomized controlled trials, and a specific manual for its implementation has been developed. Dr. (s) Ramey and DeLuca previously founded a similar clinic, The Pediatric Neuromotor Research Clinic, at the University of Alabama at Birmingham where Dr. DeLuca directed the research clinic for 13 years and oversaw the implementation of the ACQUIREc Therapy treatment protocol in more than 400 cases.

This research will involve analyzing and interpreting the clinical data of children going through clinical procedures at the FBRI VTC Neuromotor Research Clinic. All participation is voluntary and no children will denied services if families choose not to participate.


Eligibility criteria: Inclusion Criteria:

* Neuromotor Impairment

Exclusion Criteria:

* fragile health

Primary outcomes:
measure: Emerging Behaviors Scale
timeFrame: up to 12 months
Secondary outcomes:
measure: Assisting Hand Assessment
timeFrame: Within 1 week prior to treatment and Within 1 week after treatment
measure: Pediatric Motor Activity Log
timeFrame: Within 1 week prior to treatment and Within 1 week after treatment
measure: Peabody Developmental Motor Scales 2
timeFrame: Within 1 week prior to treatment and Within 1 week after treatment
measure: The Bayley Motor Scales of Infant Development -III
timeFrame: Within 1 week prior to treatment and Within 1 week after treatment
Other outcomes:
measure: Video Assessments
timeFrame: Within 1 week prior to treatment, during treatment, and Within 1 week after treatment
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute - VTC
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Stephanie DeLuca, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.