NCT03325946 The FBRI VTC Neuromotor Research Clinic
| NCT ID | NCT03325946 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Polytechnic Institute and State University |
| Condition | Neuromotor Impairments |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2013-01-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2013-01-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Stephanie DeLuca, PhD
PRINCIPAL INVESTIGATOR
Virginia Polytechnic Institute and State University
Frequently Asked Questions
Who can join the NCT03325946 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 18 Years, studying Neuromotor Impairments. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03325946 currently recruiting?
Yes, NCT03325946 is actively recruiting participants. Contact the research team at stephdeluca@vt.edu for enrollment information.
Where is the NCT03325946 trial being conducted?
This trial is being conducted at Roanoke, United States.
Who is sponsoring the NCT03325946 clinical trial?
NCT03325946 is sponsored by Virginia Polytechnic Institute and State University. The principal investigator is Stephanie DeLuca, PhD at Virginia Polytechnic Institute and State University. The trial plans to enroll 500 participants.