Neuromotor ImpairmentsNCT03325946
The FBRI VTC Neuromotor Research Clinic
An observational study of Neuromotor Impairments and Cerebral Palsy, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Neuromotor Impairments, Cerebral Palsy, Microcephaly
- What is being tested?
- ACQUIRE Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- Child, Adult
Study population: Individuals with neuromotor impairment who want to try and gain motor skills and function
Who may be able to join
- Neuromotor Impairment
Who cannot join
- fragile health
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fralin Biomedical Research Institute - VTC
Roanoke, Virginia, 24016
Stephanie DeLuca, PhD, 540-526-2098, stephdeluca@vt.edu
Laura Bateman, 540-526-2033, Laurapb2@vtc.vt.edu
About this study
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.
Read more
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.
- Conditions
- Neuromotor Impairments, Cerebral Palsy, Microcephaly, Autism, Trauma, Brain, Acquired Brain Injury
- Being tested
- ACQUIRE Therapy
- Medical subject headings
- Cerebral Palsy, Microcephaly, Autistic Disorder, Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACQUIRE TherapyBehavioural
Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs
| Study group | Role | What they receive |
|---|---|---|
| Children and Adults with Cerebral Palsy | Not described Receives: Behavioral: ACQUIRE Therapy | |
| Children and Adults with Microcephaly | Not described Receives: Behavioral: ACQUIRE Therapy | |
| Children and Adults with other Neuromotor Impairments | Not described Receives: Behavioral: ACQUIRE Therapy | |
| Children who have had a stroke | Not described Receives: Behavioral: ACQUIRE Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 12 months
Secondary outcomes (4)
Assisting Hand Assessment
This is a measure of bimanual arm and hand use
Measured: 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
Measured: 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
Measured: 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
Measured: Within 1 week prior to treatment and Within 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Jan 2013
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuromotor ImpairmentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie DeLuca, Virginia Polytechnic Institute and State University
- Investigators
- Stephanie DeLuca, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325946
- Sponsor's protocol ID
- 13-196
- Status last verified
- Jan 2026
- First submitted
- 9 Oct 2017
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is released only with participant (parental/ guardian) permission
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 39610761DeLuca 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FBRI VTC Neuromotor Research Clinic
- ClinicalTrials.gov ID
- NCT03325946
- Acronym / sponsor ID
- 13-196
- Conditions
- Neuromotor Impairments, Cerebral Palsy, Microcephaly, Autism, Trauma, Brain, Acquired Brain Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Individuals with neuromotor impairment who want to try and gain motor skills and function
Key inclusion criteria (1 listed)
- Neuromotor Impairment
Key exclusion criteria (1 listed)
- fragile health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACQUIRE TherapyIntensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs | Behavioural | Children and Adults with Cerebral Palsy, Children and Adults with Microcephaly, Children and Adults with other Neuromotor Impairments, Children who have had a stroke |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 39610761Wallace 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.
- Derived from this study: PubMed 29258560DeLuca 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.
- Individual participant dataSharing planned: No. Data is released only with participant (parental/ guardian) permission
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie DeLuca, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromotor Impairments and Cerebral Palsy, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie DeLuca, PhD (540-526-2098, stephdeluca@vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emerging Behaviors Scale (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325946, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.