The FBRI VTC Neuromotor Research Clinic

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorVirginia Polytechnic Institute and State University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Neuromotor Impairment

Disqualifiers

fragile health

Trial population

Individuals with neuromotor impairment who want to try and gain motor skills and function

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ACQUIRE Therapy

    Behavioral

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

Treatment groups

500 Participants
are divided into 4 treatment groups
Group A: Children and Adults with Cerebral Palsy1 intervention
Group B: Children and Adults with Microcephaly1 intervention
Group C: Children and Adults with other Neuromotor Impairments1 intervention
Group D: Children who have had a stroke1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to 12 months

Secondary outcomes

1

Assisting Hand Assessment

This is a measure of bimanual arm and hand use

Time frame
Within 1 week prior to treatment and Within 1 week after treatment
2

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

Time frame
Within 1 week prior to treatment and Within 1 week after treatment
3

Peabody Developmental Motor Scales 2

This is a measure of a child's motor abilities in comparison to typical development

Time frame
Within 1 week prior to treatment and Within 1 week after treatment
4

The Bayley Motor Scales of Infant Development -III

This is a measure of a infants's motor abilities in comparison to typical development

Time frame
Within 1 week prior to treatment and Within 1 week after treatment

Other outcomes

1

Video Assessments

Videos of play and therapy sessions

Time frame
Within 1 week prior to treatment, during treatment, and Within 1 week after treatment

Sponsors and contacts

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