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Could a simple brace help babies with cerebral palsy?

NCT ID NCT06027580

Symptom relief Sponsor: Medical College of Wisconsin Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a wearable trunk brace, called the SPIO Core-Max Expedition TLSO, can improve head, trunk, and arm function in infants aged 6 to 18 months with cerebral palsy. Thirty infants will wear the brace for 2 hours daily over 6 months, and researchers will measure changes in posture and quality of life compared to standard care. The goal is to see if this device offers practical benefits for daily movement and comfort.

What this could mean

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

Active substance
SPIO Core-Max Expedition TLSO (a wearable trunk brace)
What this could lead to
If it works, this brace could help infants with cerebral palsy gain better head and trunk control, possibly improving their quality of life and daily function.
What could go wrong
This is a small, early-stage study with only 30 infants. The brace may not provide meaningful benefits over standard care, and results may not apply to all children with cerebral palsy.

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.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

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.

Who is studied

Children aged 6 months to 18 months age corrected with abnormal muscle tone assessed by a provider as likely to benefit from use of a compression garment.

Ages

6 to 18 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: * Study subjects aged 6 months to 18 months age corrected with abnormal muscle tone * No previous use of SPIO® or similar Lycra/compression garments * Assessed by provider as likely to benefit from use of compression garment Exclusion Criteria: * Non-English speaking * Inability for family to bring study subject to assessments * Orthosis or casting that contraindicate SPIO® Core-MAX® during the study period * Botulinum toxin injections within 3 months, or during study participation * Having prior orthopedic or neurosurgery surgeries within one year

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Conditions

The condition(s) this trial relates to.

cerebral palsy Muscle Hypotonia Muscle Spasticity

As listed by the trial registrant

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

Cerebral palsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Medical College of Wisconsin/Children's Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

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