Menu
Recruiting NCT03325946

The FBRI VTC Neuromotor Research Clinic

Observational Neuromotor Impairments Cerebral Palsy Microcephaly Autism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACQUIRE Therapy.
Who it may be relevant to
Registry conditions: Neuromotor Impairments, Cerebral Palsy, Microcephaly, Autism. Basic parameters: 3 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Emerging Behaviors Scale [Time frame: up to 12 months]
Secondary outcome measures (4)
  • Assisting Hand Assessment [Time frame: Within 1 week prior to treatment and Within 1 week after treatment]
  • Pediatric Motor Activity Log [Time frame: Within 1 week prior to treatment and Within 1 week after treatment]
  • Peabody Developmental Motor Scales 2 [Time frame: Within 1 week prior to treatment and Within 1 week after treatment]
  • The Bayley Motor Scales of Infant Development -III [Time frame: Within 1 week prior to treatment and Within 1 week after treatment]

Eligibility criteria

Inclusion criteria

  • Neuromotor Impairment

Exclusion criteria

  • fragile health

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Fralin Biomedical Research Institute - VTC — Roanoke

Publications

  • Wallace DA, Rebekah Trucks M, DeLuca SC. Clinical use of ACQUIRE Therapy for Children Diagnosed With CASK-Gene Related Disabilities. Adv Rehabil Sci Pract. 2024 Nov 27;13:27536351241302852. doi: 10.1177/27536351241302852. eCollection 2024 Jan-Dec. PMID 39610761
  • DeLuca SC, Wallace DA, Trucks MR, Mukherjee K. A clinical series using intensive neurorehabilitation to promote functional motor and cognitive skills in three girls with CASK mutation. BMC Res Notes. 2017 Dec 19;10(1):743. doi: 10.1186/s13104-017-3065-z. PMID 29258560

Identifiers

NCT: NCT03325946 · 13-196

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗