The FBRI VTC Neuromotor Research Clinic

Study Overview
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Brief Summary
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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.

Official Title
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The FBRI VTC Neuromotor Research Clinic

Conditions
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Neuromotor Impairments, Cerebral Palsy, Microcephaly, Autism, Trauma, Brain, Acquired Brain Injury, Pediatric Stroke

Intervention / Treatment
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* Behavioral: ACQUIRE Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neuromotor Impairment Exclusion Criteria: fragile health

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children and Adults with Cerebral Palsy<br> | Behavioral: ACQUIRE Therapy<br>* Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs<br>|
| Children and Adults with Microcephaly<br> | Behavioral: ACQUIRE Therapy<br>* Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs<br>|
| Children and Adults with other Neuromotor Impairments<br> | Behavioral: ACQUIRE Therapy<br>* Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs<br>|
| Children who have had a stroke<br> | Behavioral: ACQUIRE Therapy<br>* Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |