Wereables for Upper Limb Functionality in Hemiparesis

Last updated: March 7, 2025
Sponsor: Universidade da Coruña
Overall Status: Active - Recruiting

Phase

2/3

Condition

Cerebral Palsy

Treatment

WeFun-wearable activated

WeFun-wearable desactivated

Clinical Study ID

NCT06872736
PID2021-126782OA-I00
PID2021-126782OA-I00
  • Ages 3-8
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Botulinum toxin injection or surgical interventions in the upper limb within 6months 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 referenceperson.

  • Wearable activity if presumably lower than expected (few recordings of activity, <20%).

  • Families don't provide feedback about daily sessions through the satisfaction systemin the app/registration sheet.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: WeFun-wearable activated
Phase: 2/3
Study Start date:
June 07, 2024
Estimated Completion Date:
December 20, 2026

Study Description

Cerebral palsy represents the most common paediatric neurological disorders. Unilateral cerebral palsy (UCP) subtype is the most frequent, accounting for about 0.6-1 per 1000 live births. Many children with UCP experience upper limb dysfunction, which is often more pronounced than that on lower extremity limitation. Rehabilitation strategies on the affected upper limb are of paramount importance to diminish limitations, especially those that seek to improve independence and wellbeing. These strategies are often provided through technology, which got into the clinics spotlight years ago, after extensive innovation-driven and knowledge research.

However, technology development has not reached its tops and technology solutions will drive the optimization of scientific evidence-based rehabilitation strategies. In this project, we use scientific knowledge acquired in our laboratory regarding the validation of new technologies to evaluate and treat movement disorders. Specifically, an unprecedented wearable will be used that could assess movement and complement intervention to influence function to such an extent that it would ultimately improve participation and quality of life for children with UCP.

WeFun proposes a home-based multimodal technology-based training, related to the practice of activities of daily life, to improve the use of the affected upper limb. WeFun wearable allows daily assessment of the amount of movement, in combination with training of upper limb movements and daily routines for children with CP. Our hypothesis is that a wearable technology to improve function, the We-Fun-wearable, could be an effective tool for the assessment and approach of the upper limb in children with CP.

This study has the potential to establish a new evidence-based and cost-effective therapy, accessible to children with cerebral palsy and their families, so that a digital solution can be provided for a vulnerable group: children with disabilities.

Connect with a study center

  • Universidade da Coruña

    A Coruña, 15006
    Spain

    Active - Recruiting

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