The FBRI VTC Neuromotor Research Clinic

Cerebral Palsy Clinical Trial

Official title:

The FBRI VTC Neuromotor Research Clinic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03325946
• Other study ID #: 13-196
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Virginia Polytechnic Institute and State University
• Contact: Stephanie DeLuca, PhD
• Phone: 540-526-2098
• Email: stephdeluca[@]vt.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

Inclusion Criteria:

• Neuromotor Impairment

Exclusion Criteria:

• fragile health

Related Conditions & MeSH terms

• Acquired Brain Injury
• Autism
• Brain Injuries
• Brain Injuries, Traumatic
• Cerebral Palsy
• Microcephaly
• Neuromotor Impairments
• Pediatric Stroke
• Trauma, Brain

Intervention

Behavioral:
• ACQUIRE Therapy
Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute - VTC	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Video Assessments	Videos of play and therapy sessions	Within 1 week prior to treatment, during treatment, and Within 1 week after treatment
Primary	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	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
Secondary	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
Secondary	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
Secondary	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