NCT06872736

Wereables for Upper Limb Functionality in Hemiparesis

Innovative Use of Wereable Technology for Improving Functionality in Children with Unilateral Cerebral Palsy

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universidade da Coruña · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Unilateral Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	WeFun-wearable activated	1 month daily routine program with weekly visits in natural environments (home, community, etc) together with WeFun-weareable to increase spontaneous use of the upper limb in children with UCP during activities of daily life and leisure. Activities are priorized by Canadian Occupational Performance Measure and Goal Atteinment Scale. Programs are designed together with a transdisciplinary team, acting as consultants. Children in the experimental group will have the wearable's experimental movement functions activated.
DEVICE	WeFun-wearable desactivated	1 month daily routine program with weekly visits in natural environments (home, community, etc) together with WeFun-weareable to increase spontaneous use of the upper limb in children with UCP during activities of daily life and leisure. Activities are priorized by Canadian Occupational Performance Measure and Goal Atteinment Scale. Programs are designed together with a transdisciplinary team, acting as consultants. Children in the control group will not have experimental functions in their wearables.

Timeline

• Start date: 2024-06-07
• Primary completion: 2024-09-14
• Completion: 2026-12-20
• First posted: 2025-03-12
• Last updated: 2025-03-12

Locations

1 site across 1 country: Spain