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Can early intensive therapy boost motor skills in kids with cerebral palsy?

NCT ID NCT04362800

Disease control Sponsor: University Hospital, Brest Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an early, intensive therapy program called HABIT-ILE in 36 preschool children (ages 1-4) with bilateral cerebral palsy. The therapy focuses on coordinated use of both hands and legs through structured activities. Researchers measured changes in gross motor function and daily performance to see if starting this therapy early can improve outcomes.

What this could mean

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

Active substance
Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)
What this could lead to
If successful, this could point toward an effective early intervention to improve motor skills and daily function in young children with bilateral cerebral palsy.
What could go wrong
This is a small, early-stage study with only 36 participants, so results may not apply to all children. The therapy is intensive and may be challenging for some families to maintain.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Jan 2021

Finished

Sep 2021

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

12 to 59 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 with bilateral cerebral palsy proven to be spastic or dyskinetic * 1 to 4 years old inclusive (12 to 59 months) (age corrected if premature) able to follow instructions and to be able to carry out all the assessments, in accordance with his age * Being matched to a child according to age, etiology of CP / classification of motor function (GMFCS) * Signature of consent by the two holders of parental authority Exclusion Criteria: * Exceed 4 years and 11 months (59 months) during the internship evaluation period. * Uncontrolled epilepsy. * History of toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period). * Visual or cognitive deficit preventing the child from seeing the games and interacting * Usual contraindications to magnetic resonance imaging (MRI) such as metal implants.

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Conditions

The condition(s) this trial relates to.

cerebral palsy

As listed by the trial registrant

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

Cerebral palsy

Contacts and locations

Locations

  • Fondation ILDYS - Site de Ty Yann

    Brest, Brest, 29000, France

  • Les Capucins

    Angers, Angers, 49000, France

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