Hemiparetic Cerebral PalsyNCT00991692
A Multisite Trial of ACQUIREc Therapy
A study testing Therapy services (ACQUIREc Therapy) in people with Hemiparetic Cerebral Palsy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
A multisite trial to testing different dosage levels of a systematic form of Pediatric Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6 hours of daily therapy services for 21 days. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Hemiparetic Cerebral Palsy
- What is being tested?
- Therapy services (ACQUIREc Therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 3-6 years of age
- Hemiparetic CP
Who cannot join
- No prior CI therapy treatments
- No Botox for 6-months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35124
About this study
A multisite trial to testing different dosage levels of a systematic form of Pediatric Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6 hours of daily therapy services for 21 days. This was compared to a moderate dosage level of 3 hours of daily therapy services for 21 days. It was hypothesized that children receiving the higher therapy dosage would have greater and more clinically significant benefits from ACQUIREc Therapy but that both groups of children would benefit from the therapy services.
- Conditions
- Hemiparetic Cerebral Palsy
- Being tested
- Therapy services (ACQUIREc Therapy)
- Keywords
- Pediatric CI Therapy, ACQUIREc Therapy, Dosage, Occupational Therapy, Physical Therapy, Cerebral Palsy, Hemiparesis
- Medical subject headings
- Cerebral Palsy, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy services (ACQUIREc Therapy)Other
Also called Occupational Therapy, Physical Therapy, Pediatric CI Therapy, ACQUIREc Therapy
Dosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals.
| Study group | Role | What they receive |
|---|---|---|
| Treatment dosage levels examined | Experimental | Not described Receives: Other: Therapy services (ACQUIREc Therapy) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiparetic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Stephanie C DeLuca, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991692
- Sponsor's protocol ID
- deluca-ms1
- Status last verified
- Oct 2009
- First submitted
- 7 Oct 2009
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
DeLuca SC, Case-Smith J, Stevenson R, Ramey SL. Constraint-induced movement therapy (CIMT) for young children with cerebral palsy: effects of therapeutic dosage. J Pediatr Rehabil Med. 2012;5(2):133-42. doi: 10.3233/PRM-2012-0206.
PubMed 22699104
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multisite Trial of ACQUIREc Therapy
- ClinicalTrials.gov ID
- NCT00991692
- Acronym / sponsor ID
- deluca-ms1
- Conditions
- Hemiparetic Cerebral Palsy
- Keywords
- Pediatric CI Therapy, ACQUIREc Therapy, Dosage, Occupational Therapy, Physical Therapy, Cerebral Palsy, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Oct 2009 (estimated)
- 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.
A multisite trial to testing different dosage levels of a systematic form of Pediatric Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6 hours of daily therapy services for 21 days. This was compared to a moderate dosage level of 3 hours of daily therapy services for 21 days. It was hypothesized that children receiving the higher therapy dosage would have greater and more clinically significant benefits from ACQUIREc Therapy but that both groups of children would benefit from the therapy services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment dosage levels examined | Experimental | Other: Therapy services (ACQUIREc Therapy) |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 3-6 years of age
- Hemiparetic CP
Key exclusion criteria (2 listed)
- No prior CI therapy treatments
- No Botox for 6-months
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 |
|---|---|---|
| Therapy services (ACQUIREc Therapy)Also: Occupational Therapy, Physical Therapy, Pediatric CI Therapy, ACQUIREc TherapyDosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals. | Other | Treatment dosage levels examined |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2009.
- Derived from this study: PubMed 22699104DeLuca SC, Case-Smith J, Stevenson R, Ramey SL. Constraint-induced movement therapy (CIMT) for young children with cerebral palsy: effects of therapeutic dosage. J Pediatr Rehabil Med. 2012;5(2):133-42. doi: 10.3233/PRM-2012-0206.
Related trials for Hemiparetic Cerebral Palsy
Active, not recruiting
Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy
Cerebral Palsy (CP), Hemiparetic Cerebral Palsy
Not yet recruiting
Mirror Therapy in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy, Mirror Hands
Not yet recruiting
Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP
Hemiparetic Cerebral Palsy
Active, not recruiting
Effect of Blood Flow Restriction Training Exercises on Hand Grip Strength in Hemiparetic Cerebral Palsied Children
Cerebral Palsy Spastic Hemiplegic
RecruitingObservational study
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
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. This study is not recruiting at the moment.
Stephanie C DeLuca, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy services (ACQUIREc Therapy) in people with Hemiparetic Cerebral Palsy, run by University of Alabama at Birmingham 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Oct 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00991692, which also lists 1 linked publication.
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 8 Oct 2009.