Intensive Infant Rehabilitation for Perinatal Stroke

(I-ACQUIRE Trial)

Not currently recruiting at 17 trial locations

Overseen By Stephanie DeLuca, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Botulinum toxin

Disqualifiers: Uncontrolled seizures, Fragile health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new infant rehabilitation program called I-ACQUIRE for babies who experienced a Perinatal Arterial Stroke (PAS). The study compares two different schedules of I-ACQUIRE therapy to usual treatment methods to determine which is more effective. One group will receive a moderate therapy dose, another a high dose, and the last will continue with usual treatments. The trial seeks babies aged 8-36 months with PAS and hemiparesis (weakness on one side of the body). Parents must be willing to participate in therapy at home and communicate in English with the study team. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment for infant rehabilitation.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this infant rehabilitation protocol is safe for infants with perinatal stroke?

Research has shown that the I-ACQUIRE treatment for infants with perinatal arterial stroke (PAS) is generally safe and well-received in earlier studies. This treatment is administered in two different doses: a moderate dose of 3 hours a day and a high dose of 6 hours a day, both for 5 days a week over 4 weeks.

Although specific safety data for each dose is not available, the Phase III status of the study indicates that earlier phases found the treatment to be generally safe and well-tolerated. Phase III trials typically aim to confirm a treatment's effectiveness and monitor side effects after establishing safety in earlier phases. No specific reports of negative side effects related to the I-ACQUIRE treatment have been noted in the data provided. This suggests that while the treatment is still under investigation, it is considered safe enough for study in larger groups of participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-ACQUIRE approach because it aims to enhance recovery from perinatal stroke in infants with a more intensive rehab technique. Unlike typical therapies that might not focus as intensively on affected limbs, the I-ACQUIRE program involves structured, repetitive training. The high-dose arm delivers six hours of therapy each day, while the moderate-dose provides three hours, both far exceeding conventional therapy durations. This intensive, focused approach is designed to harness the brain's plasticity during a crucial developmental window, potentially leading to more significant improvements in motor skills and overall recovery.

What evidence suggests that this trial's treatments could be effective for infants with Perinatal Arterial Stroke?

Research shows that the I-ACQUIRE rehabilitation program might help infants who have experienced a stroke around the time of birth. In this trial, participants will join different treatment arms, including the I-ACQUIRE program with intensive therapy sessions of either 6 hours a day (high dose) or 3 hours a day (moderate dose) for four weeks. Studies have found that such intensive therapy can improve movement skills in young children affected by these strokes. The goal is for these longer therapy sessions to enhance infants' physical development. While more results are needed, early data suggests that I-ACQUIRE could significantly aid recovery. ^{1 2 3 4 6}

Who Is on the Research Team?

Sharon L Ramey, Ph.D.

Principal Investigator

Virginia Polytechnic Institute and State University

Warren Lo, M.D.

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

This trial is for infants aged 8-36 months who have had a Perinatal Arterial Stroke, resulting in hemiparesis. They must not have received certain previous treatments like high-dose movement therapy or botulinum toxin within the last three months. One parent must be English-speaking to interact with study staff and manage home therapy.

Inclusion Criteria

My child has weakness on one side of their body.

My parent(s) agree to be part of the home therapy.

My child was diagnosed with a stroke that occurred around the time of birth.

Exclusion Criteria

My child was given botulinum toxin in the last 3 months.

My child has undergone intensive movement therapy for at least 2 hours a day over 10 days.

My child's health condition prevents them from fully participating in therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Moderate Dose I-ACQUIRE (3 hrs/day, 5 days/wk for 4 weeks), High Dose I-ACQUIRE (6 hrs/day, 5 days/wk for 4 weeks), or Usual and Customary Treatment

4 weeks

Weekly monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at baseline, end of treatment, and 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• I-ACQUIRE - High Dosage
• I-ACQUIRE - Moderate Dosage
• Usual & Customary Treatment (U&CT)

Trial Overview The trial tests two different doses of a new infant rehabilitation protocol called I-ACQUIRE against standard rehab methods for babies who've had strokes. It aims to see which dosage improves motor skills better.

How Is the Trial Designed?

Group I: I-ACQUIRE Moderate Dose Experimental Treatment 1 Intervention

Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)

Group II: I-ACQUIRE High Dose Experimental Treatment 1 Intervention

High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)

Group III: Usual & Customary Treatment Active Control 1 Intervention

Usual \& Customary Treatment

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

A randomized controlled trial involving 123 stroke patients found that an early increased-intensity upper limb therapy program did not lead to better outcomes compared to standard care, as measured by the Action Research Arm Test three months post-stroke.

Despite the intervention group receiving more total therapy time (median of 52 minutes/day) than the control group (38 minutes/day), the expected benefits were not realized, likely due to competitive therapy bias affecting the actual therapy received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an early increased-intensity interdisciplinary upper limb therapy programme following acute stroke improve outcome? Rodgers, H., Mackintosh, J., Price, C., et al.[2017]

In a study of 68 patients with moderate-to-severe traumatic brain injury (TBI), those undergoing high-intensity rehabilitation (4 hours/day) showed a faster recovery, achieving higher scores on the Functional Independence Measure (FIM) and Glasgow Outcome Scale (GOS) in the early months compared to those in a lower intensity program (2 hours/day).

While early intensive rehabilitation improved recovery speed, it did not significantly change the final functional outcomes, suggesting that while it helps patients regain independence sooner, it may not affect long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. Zhu, XL., Poon, WS., Chan, CC., et al.[2014]

Stroke survivors often face long-term disabilities, and current rehabilitation practices do not provide enough intensity or dosage of training to promote significant recovery.

The review suggests various therapeutic strategies, such as constraint-induced movement therapy and robotics, that can enhance training intensity and dosage, potentially leading to better recovery outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting dose and intensity of training: Opportunities to enhance recovery following stroke. Donnellan-Fernandez, K., Ioakim, A., Hordacre, B.[2022]

Citations

1. childrenshospital.org childrenshospital.org/clinical-trials/nct03910075

NCT03910075 This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms ...

2. nihstrokenet.org nihstrokenet.org/trials/i-acquire/resources

I-ACQUIRE - Perinatal Arterial Stroke - A Multi-site RCT of ... Briefly, I-ACQUIRE will be used to treat 8 – 36 month old children with PAS in either 3 hours/day (Moderate Dose) or 6 hours/day (High Dose) for 5 days/week for ...

3. nationwidechildrens.org nationwidechildrens.org/research/clinical-research/neurology-and-neurosciences-clinical-research/i-acquire

Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant ... This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol -- I-ACQUIRE -- to usual and customary forms ...

4. nihstrokenet.org nihstrokenet.org/trials/i-acquire/home

I-ACQUIRE - Perinatal Arterial Stroke - A Multi-site RCT of ... I-ACQUIRE will be used to treat 8 – 36-month-old children with PAS in either 3 hours/day (Moderate Dose) or 6 hours/day (High Dose) for 5 days/week for 4 weeks.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03910075?term=AREA%5BBasicSearch%5D(pediatric%20stroke)&rank=6

Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

6. withpower.com withpower.com/trial/phase-3-stroke-9-2019-bed4a?lat=36.65114&lng=-97.3517

Intensive Infant Rehabilitation for Perinatal Stroke The research articles provided do not contain specific safety data for intensive infant rehabilitation for perinatal stroke or related treatments like I-ACQUIRE ...