Intensive Infant Rehabilitation for Perinatal Stroke

(I-ACQUIRE Trial)

Recruiting at 16 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

216 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment I-ACQUIRE for Intensive Infant Rehabilitation for Perinatal Stroke?

Research on increased-intensity rehabilitation for stroke and traumatic brain injury (TBI) suggests that more intensive therapy can improve outcomes, particularly for upper limb impairments. This implies that similar intensive approaches, like I-ACQUIRE, might be beneficial for infants with perinatal stroke. ^{1 2 3 4 5}

Is intensive infant rehabilitation for perinatal stroke safe?

The research articles provided do not contain specific safety data for intensive infant rehabilitation for perinatal stroke or related treatments like I-ACQUIRE. They focus on stroke rehabilitation in adults and do not address safety in infants. ^{2 4 6 7 8}

How is the I-ACQUIRE treatment for perinatal stroke different from other treatments?

The I-ACQUIRE treatment is unique because it involves intensive rehabilitation specifically designed for infants who have experienced a perinatal stroke, focusing on high and moderate dosage levels of therapy. This approach is different from usual and customary treatments, which may not be as intensive or tailored to the specific needs of infants with this condition. ^{9 10 11 12 13}

What is the purpose of this trial?

This trial is testing a new therapy program called I-ACQUIRE for infants who have had a stroke. The program involves intensive sessions with therapists to help improve movement and strength. The study will compare two different amounts of therapy to usual treatments to see which works best.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Does an early increased-intensity interdisciplinary upper limb therapy programme following acute stroke improve outcome? [2017]

2. England pubmed.ncbi.nlm.nih.gov

Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Dose of Rehabilitation Approaches for Severe Upper Limb Impairments and Disability During Early Acute and Subacute Stroke: A Systematic Review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

An early mobilization protocol successfully delivers more and earlier therapy to acute stroke patients: further results from phase II of AVERT. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Determining optimal poststroke exercise: Study protocol for a randomized controlled trial investigating therapeutic intensity and dose on functional recovery during stroke inpatient rehabilitation. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Revisiting dose and intensity of training: Opportunities to enhance recovery following stroke. [2022]

7. England pubmed.ncbi.nlm.nih.gov

How are balance and mobility problems after stroke treated in England? An observational study of the content, dose and context of physiotherapy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Risks of acute hospital transfer and mortality during stroke rehabilitation. [2022]

9. China pubmed.ncbi.nlm.nih.gov

Comparison of the intervention methods for perinatal brain injury. [2006]

10. England pubmed.ncbi.nlm.nih.gov

Current Therapeutic Management of Perinatal Stroke with a Focus on the Upper Limb: A Cross-Sectional Survey of UK Physiotherapists and Occupational Therapists. [2022]

11. Singapore pubmed.ncbi.nlm.nih.gov

Neonatal stroke: Clinical characteristics and neurodevelopmental outcomes. [2022]

12. China pubmed.ncbi.nlm.nih.gov

[Application of stroke rehabilitation unit in municipal hospitals during the acute phase of cerebral infarction]. [2008]

13. China pubmed.ncbi.nlm.nih.gov

[Early rehabilitation intervention reduces the incidence of extrauterine growth retardation in preterm infants]. [2020]