Wereables for Upper Limb Functionality in Hemiparesis
Recruiting
Phase 2Phase 3Interventional Study
Unilateral Cerebral Palsy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
3 – 8
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Universidade da Coruña · Other
Who this trial is looking for
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The project is configured as a national interventional study that aims to determine the effectiveness of an intervention strategy using wearable technology, tailored to improve function (WeFun-wearable), on the spontaneous use of the affected upper extremity, activities of daily living and the participation in children with unilateral cerebral palsy.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Confirmed diagnosis of UCP.
* Children aged between 3 and 8 years old.
* Children rated on levels I to III on the Manual Ability Classification System (MACS).
Exclusion Criteria:
* Botulinum toxin injection or surgical interventions in the upper limb within 6 months prior to…
Inclusion Criteria:
* Confirmed diagnosis of UCP.
* Children aged between 3 and 8 years old.
* Children rated on levels I to III on the Manual Ability Classification System (MACS).
Exclusion Criteria:
* Botulinum toxin injection or surgical interventions in the upper limb within 6 months prior to study entry.
* Medical complications non-controlled that would interfere with study participation (e.g., not controlled epilepsy).
* Predominantly athetoid or dystonia movement patterns.
* Insufficient cognitive level to follow instructions,
* Non-corrected marked visual impairments.
Families can be retired from the study after starting if:
* Families don't assist or don't collaborate in the weekly sessions with the reference person.
* Wearable activity if presumably lower than expected (few recordings of activity, \<20%).
* Families don't provide feedback about daily sessions through the satisfaction system in the app/registration sheet.
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