The FBRI VTC Neuromotor Research Clinic

NCT03325946 | Recruiting

• 1 other identifier: 13-196
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromotor Impairments; Cerebral Palsy; Microcephaly; Autism; Trauma, Brain; Acquired Brain Injury; Pediatric Stroke

Outcome Measures

Primary Outcomes (1)

• Emerging Behaviors Scale

  This is a measure of the number of skills a child uses from a set of 31 typical used on a daily basis

  up to 12 months

Secondary Outcomes (4)

• Assisting Hand Assessment

  Within 1 week prior to treatment and Within 1 week after treatment

• Pediatric Motor Activity Log

  Within 1 week prior to treatment and Within 1 week after treatment

• Peabody Developmental Motor Scales 2

  Within 1 week prior to treatment and Within 1 week after treatment

• The Bayley Motor Scales of Infant Development -III

  Within 1 week prior to treatment and Within 1 week after treatment

Other Outcomes (1)

• Video Assessments

  Within 1 week prior to treatment, during treatment, and Within 1 week after treatment

Study Arms (4)

Children and Adults with Cerebral Palsy

Behavioral: ACQUIRE Therapy

Children and Adults with Microcephaly

Behavioral: ACQUIRE Therapy

Children and Adults with other Neuromotor Impairments

Behavioral: ACQUIRE Therapy

Children who have had a stroke

Behavioral: ACQUIRE Therapy

Interventions

ACQUIRE Therapy BEHAVIORAL

Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs

Children and Adults with Cerebral Palsy; Children and Adults with Microcephaly; Children and Adults with other Neuromotor Impairments; Children who have had a stroke

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with neuromotor impairment who want to try and gain motor skills and function

You may qualify if:

• Neuromotor Impairment

You may not qualify if:

• fragile health

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute - VTC

Roanoke, Virginia, 24016, United States

RECRUITING

Related Publications (2)

• Wallace DA, Rebekah Trucks M, DeLuca SC. Clinical use of ACQUIRE Therapy for Children Diagnosed With CASK-Gene Related Disabilities. Adv Rehabil Sci Pract. 2024 Nov 27;13:27536351241302852. doi: 10.1177/27536351241302852. eCollection 2024 Jan-Dec.

  PMID: 39610761 DERIVED

• 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.

  PMID: 29258560 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Microcephaly; Autistic Disorder; Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Stephanie DeLuca, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie DeLuca, PhD

CONTACT

540-526-2098; stephdeluca@vt.edu

Laura Bateman

CONTACT

540-526-2033; laurapb2@vtc.vt.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 30, 2017
• Study Start: January 1, 2013
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)