Recruiting

Observational Study

Sponsor:

Virginia Polytechnic Institute and State University

Code:

NCT03325946

Conditions

Neuromotor Impairments

Cerebral Palsy

Microcephaly

Autism

Trauma, Brain

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

ACQUIRE Therapy

Study Details

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.

Conditions

Neuromotor Impairments

Cerebral Palsy

Microcephaly

Autism

Trauma, Brain

Study ID

NCT03325946

Start date

Jan 1, 2013

Status verified date

Jan, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Neuromotor Impairment

Exclusion Criteria:

  • fragile health

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Children and Adults with Cerebral Palsy

Children and Adults with Microcephaly

Children and Adults with other Neuromotor Impairments

Children who have had a stroke

Interventions

ACQUIRE Therapy

Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs

Primary outcome measure

  • Emerging Behaviors Scale [ Time Frame: up to 12 months ]

Central Contacts and Locations

Central contacts

Locations

Fralin Biomedical Research Institute - VTC

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

More Information

Sponsor

Virginia Polytechnic Institute and State University

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Virginia Polytechnic Institute and State University on 2026-01-21.