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The FBRI VTC Neuromotor Research Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03325946
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie DeLuca, Virginia Polytechnic Institute and State University

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.


Condition or disease Intervention/treatment
Neuromotor Impairments Cerebral Palsy Microcephaly Autism Trauma, Brain Acquired Brain Injury Behavioral: ACQUIRE Therapy

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The FBRI VTC Neuromotor Research Clinic
Actual Study Start Date : January 1, 2013
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027


Group/Cohort Intervention/treatment
Children and Adults with Cerebral Palsy Behavioral: ACQUIRE Therapy
Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs

Children and Adults with Microcephaly Behavioral: ACQUIRE Therapy
Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs

Children and Adults with other Neuromotor Impairments Behavioral: ACQUIRE Therapy
Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs




Primary Outcome Measures :
  1. Emerging Behaviors Scale [ Time Frame: up to 12 months ]
    This is a measure of the number of skills a child uses from a set of 31 typical used on a daily basis


Secondary Outcome Measures :
  1. Assisting Hand Assessment [ Time Frame: Within 1 week prior to treatment and Within 1 week after treatment ]
    This is a measure of bimanual arm and hand use

  2. Pediatric Motor Activity Log [ Time Frame: Within 1 week prior to treatment and Within 1 week after treatment ]
    This is a parental report about a child's ability to use an impaired arm and hand on a daily basis

  3. Peabody Developmental Motor Scales 2 [ Time Frame: Within 1 week prior to treatment and Within 1 week after treatment ]
    This is a measure of a child's motor abilities in comparison to typical development

  4. The Bayley Motor Scales of Infant Development -III [ Time Frame: Within 1 week prior to treatment and Within 1 week after treatment ]
    This is a measure of a infants's motor abilities in comparison to typical development



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Individuals with neuromotor impairment who want to try and gain motor skills and function
Criteria

Inclusion Criteria:

  • Neuromotor Impairment

Exclusion Criteria:

  • fragile health

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325946


Contacts
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Contact: Stephanie DeLuca, PhD 540-526-2098 stephdeluca@vt.edu
Contact: Laura Bateman 540-526-2033 laurapb2@vtc.vt.edu

Locations
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United States, Virginia
Fralin Biomedical Research Institute - VTC Recruiting
Roanoke, Virginia, United States, 24016
Contact: Stephanie DeLuca, PhD    540-526-2098    stephdeluca@vt.edu   
Contact: Laura Bateman    540-526-2033    Laurapb2@vtc.vt.edu   
Fralin Biomedical Research Institute - VTC Recruiting
Roanoke, Virginia, United States, 24016
Contact: Stephanie C DeLuca, PhD    540-526-2098    stephdeluca@vt.edu   
Contact: Laura Bateman    540-526-2033    laurapb2@vt.edu   
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Investigators
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Principal Investigator: Stephanie DeLuca, PhD Virginia Polytechnic Institute and State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stephanie DeLuca, Associate Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT03325946    
Other Study ID Numbers: 13-196
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data is released only with participant (parental/ guardian) permission

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Microcephaly
Brain Injuries
Cerebral Palsy
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Malformations of Cortical Development, Group I
Malformations of Cortical Development
Nervous System Malformations
Congenital Abnormalities