RecruitingPhase 2Phase 3NCT06872736

Wereables for Upper Limb Functionality in Hemiparesis

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


Sponsor

Universidade da Coruña

Enrollment

40 participants

Start Date

Jun 7, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 YearsMax Age: 8 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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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Interventions

DEVICEWeFun-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.

DEVICEWeFun-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.


Locations(1)

Universidade da Coruña

A Coruña, A Coruña, Spain

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NCT06872736


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