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Can intensive hand therapy help babies recover from stroke?

NCT ID NCT03910075

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new intensive therapy called I-ACQUIRE for infants aged 8 to 36 months who had a stroke around birth and have weakness on one side. The therapy involves guided play and movement exercises for either 3 or 6 hours a day, 5 days a week for 4 weeks. Researchers compared these two dosages to standard rehab to see if the therapy helps babies gain new arm and hand skills.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
I-ACQUIRE therapy (a form of pediatric constraint-induced movement therapy)
What this could lead to
If successful, this could establish an effective rehabilitation approach to improve arm and hand function in infants who had a stroke around birth.
What could go wrong
The trial is completed but results are not yet widely reported. The therapy is intensive (up to 6 hours daily) and may be difficult for families to sustain. Benefits may vary by child.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

216 people

The number who actually took part.

Started

Oct 2019

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 36 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * child will be 8 - 36 months old when study treatment will be delivered * child has a diagnosis of Perinatal Arterial Stroke (PAS) * parent permission to provide the child's clinical MRI to the study * child has hemiparesis * parent(s) willing to participate in the home therapy component * one parent English language proficient and will take the lead in interacting with study staff and completing self-administered forms and interviews in English Exclusion Criteria: * child has medical or sensory condition(s) that prevent(s) full therapy participation (e.g., frequent uncontrolled seizures, fragile health) * child previously received Constraint-Induced Movement Therapy (CIMT) or modified CIMT with a dose of at least 2 hrs/day for ≥10 days * child received botulinum toxin in past 3 months * child is a ward of the state or other agency

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Fralin Biomedical Research Institute at Virginia Tech

    Roanoke, Virginia, 24016, United States

  • Kennedy Krieger Institute - Fairmount Rehabilitation

    Baltimore, Maryland, 21231, United States

  • Martha Morehouse Medical Plaza

    Columbus, Ohio, 43210, United States

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030, United States

  • Scottish Rite for Children - Dallas

    Dallas, Texas, 75219, United States

  • The Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425, United States

  • USCD Health La Jolla

    La Jolla, California, 92037, United States

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53792, United States

  • Washington University School of Medicine, St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Yale New Haven Children's Hospital

    New Haven, Connecticut, 06511, United States

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Other studies related to the condition(s) this trial covers.