The FBRI VTC Neuromotor Research Clinic
Part of paid clinical trials in Roanoke, Virginia.
- Sponsor
- Virginia Polytechnic Institute and State University
- Study ID
- NCT03325946
- Status
- Recruiting
Conditions
- Acquired Brain Injury
- Autism
- Cerebral Palsy
- Microcephaly
- Neuromotor Impairments
- Pediatric Stroke
- Trauma, Brain
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Months - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- ACQUIRE Therapy — BEHAVIORALIntensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs
Study Details
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.
Key Dates
- Start date
- Jan 1, 2013
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 500 participants (estimated)
Arms
- Arm: Children and Adults with Cerebral Palsy
- Arm: Children and Adults with Microcephaly
- Arm: Children and Adults with other Neuromotor Impairments
- Arm: Children who have had a stroke
Primary Outcome Measure
Emerging Behaviors Scale [ Time Frame: up to 12 months ]
Central Contacts
- Stephanie DeLuca, PhD540-526-2098
- Laura Bateman540-526-2033
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fralin Biomedical Research Institute - VTC | Roanoke | Virginia | 24016 |
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