Recruiting PHASE2, PHASE3 Unilateral Cerebral Palsy

New treatment option for Unilateral Cerebral Palsy

Official title Wereables for Upper Limb Functionality in Hemiparesis

ClinicalTrials.gov ID: NCT06872736

What this study is testing

What it's testing
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.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 3 to 8

You may be able to join if

  • 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).

You likely can't join if

  • 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.
See the full eligibility criteria
Who can join
  • 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).
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • A Coruña, A Coruña, Spain

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 3 years to 8 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include A Coruña, A Coruña, Spain. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.