Wereables for Upper Limb Functionality in Hemiparesis (NCT06872736) | Clinical Trial Compass
RecruitingPhase 2/3
Wereables for Upper Limb Functionality in Hemiparesis
Spain40 participantsStarted 2024-06-07
Plain-language summary
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.
Who can participate
Age range3 Years – 8 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Bimanual performance/functional hand use
Timeframe: Baseline, immediately after the intervention and after 2 months follow-up