ClinicalTrials.gg
RecruitingNCT03325946Updated Jan 21, 2026

The FBRI VTC Neuromotor Research Clinic

An observational study in Neuromotor Impairments, Cerebral Palsy and Microcephaly, sponsored by Virginia Polytechnic Institute and State University. Recruiting at 1 site in United States. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Virginia Polytechnic Institute and State University · Observational

From the registry’s dates

  • Started Jan 2013; still recruiting 13 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
3 Months to 18 Years
Sex
All
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Study 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.

02

Conditions studied

  • Neuromotor Impairments
  • Cerebral Palsy
  • Microcephaly
  • Autism
  • Trauma, Brain
  • Acquired Brain Injury
  • Pediatric Stroke
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's planned enrollment of 500 is above the median of 63 across 472 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 127 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Neuromotor Impairment

Exclusion criteria

Exclusion Criteria:

  • fragile health
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Children and Adults with Cerebral Palsy

    Behavioral: ACQUIRE Therapy

  • Children and Adults with Microcephaly

    Behavioral: ACQUIRE Therapy

  • Children and Adults with other Neuromotor Impairments

    Behavioral: ACQUIRE Therapy

  • Children who have had a stroke

    Behavioral: ACQUIRE Therapy

Interventions

  • BehavioralACQUIRE Therapy

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 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. PubMed 29258560 ↗

Individual participant data

Plan to share: No — Data is released only with participant (parental/ guardian) permission

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2013 (actual). Primary completion is estimated for Dec 2029, 203 months after the start.

Of 214 non-industry observational studies under Cerebral Palsy, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 60. This study's planned 203 months is above that.

Counting every sponsor, half of 218 studies reached it within 21 months; a quarter within 8 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2017
First posted
Oct 30, 2017
StartActual
Jan 1, 2013
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2029
Last update
Jan 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03325946
Responsible party
Stephanie DeLuca (Associate Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Oct 30, 2017
Start date
Jan 1, 2013
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jan 21, 2026

Study contacts

Stephanie DeLuca, PhD
Contact
stephdeluca@vt.edu
540-526-2098
Laura Bateman
Contact
laurapb2@vtc.vt.edu
540-526-2033
Stephanie DeLuca, PhD
principal investigator · Virginia Polytechnic Institute and State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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