The FBRI VTC Neuromotor Research Clinic

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Microcephaly; Acquired Brain Injury; Autism; Trauma, Brain; Neuromotor Impairments; Pediatric Stroke
• Intervention / Treatment: Behavioral: ACQUIRE Therapy

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Laura Bateman; Phone Number: 540-526-2033; Email: Laurapb2@vtc.vt.edu
• Study Contact Backup: Name: Stephanie DeLuca, PhD; Phone Number: 540-526-2098; Email: stephdeluca@vt.edu

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Recruiting
      • Fralin Biomedical Research Institute - VTC
      • Contact: Laura Bateman; Phone Number: 540-526-2033; Email: Laurapb2@vtc.vt.edu
      • Contact: Stephanie DeLuca, PhD; Phone Number: 540-526-2098; Email: stephdeluca@vt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Neuromotor Impairment

Exclusion Criteria:

• fragile health

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children and Adults with Cerebral Palsy	Behavioral: ACQUIRE Therapy; Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs
Children and Adults with Microcephaly	Behavioral: ACQUIRE Therapy; Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs
Children and Adults with other Neuromotor Impairments	Behavioral: ACQUIRE Therapy; Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs
Children who have had a stroke	Behavioral: ACQUIRE Therapy; Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assisting Hand Assessment	This is a measure of bimanual arm and hand use	Within 1 week prior to treatment and Within 1 week after treatment
Pediatric Motor Activity Log	This is a parental report about a child's ability to use an impaired arm and hand on a daily basis	Within 1 week prior to treatment and Within 1 week after treatment
Peabody Developmental Motor Scales 2	This is a measure of a child's motor abilities in comparison to typical development	Within 1 week prior to treatment and Within 1 week after treatment
The Bayley Motor Scales of Infant Development -III	This is a measure of a infants's motor abilities in comparison to typical development	Within 1 week prior to treatment and Within 1 week after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Video Assessments	Videos of play and therapy sessions	Within 1 week prior to treatment, during treatment, and Within 1 week after treatment

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Investigators: Principal Investigator: Stephanie DeLuca, PhD, Virginia Polytechnic Institute and State University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Congenital Abnormalities; Brain Damage, Chronic; Musculoskeletal Diseases; Craniocerebral Trauma; Trauma, Nervous System; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Cerebral Palsy; Brain Injuries; Brain Injuries, Traumatic; Microcephaly
• Other Study ID Numbers: 13-196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data is released only with participant (parental/ guardian) permission

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No