The FBRI VTC Neuromotor Research Clinic

Recruiting

• Conditions: Neuromotor Impairments; Cerebral Palsy; Acquired Brain Injury; Microcephaly; Trauma, Brain; Autism; Pediatric Stroke
• Interventions: Behavioral: ACQUIRE Therapy

• Registration Number: NCT03325946
• Lead Sponsor: Virginia Polytechnic Institute and State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-10-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Neuromotor Impairment

Exclusion Criteria

• fragile health

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children and Adults with Microcephaly	ACQUIRE Therapy	-
Children and Adults with Cerebral Palsy	ACQUIRE Therapy	-
Children and Adults with other Neuromotor Impairments	ACQUIRE Therapy	-
Children who have had a stroke	ACQUIRE Therapy	-

Primary Outcome Measures

Name	Time	Method
Emerging Behaviors Scale	up to 12 months	This is a measure of the number of skills a child uses from a set of 31 typical used on a daily basis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fralin Biomedical Research Institute - VTC; 🇺🇸 Roanoke, Virginia, United States