Wereables for Upper Limb Functionality in Hemiparesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-07

Study Completion Date

2026-12-20

Brief Summary

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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.

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Detailed Description

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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

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Unilateral Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Selected Physical Therapy Program, wearable, routine program, double blind, contrabalanced randomization

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Allocation in the experimental and control group is blinded for children, families and researchers who assesses. Outcome measures are blinded for the researcher doing the intervention. Researchers doing the analysis are blinded to the conditions.

Study Groups

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1 month daily routine program with wefun-weareable activated

Children will follow a daily routine program based on goals set by families, which will be initiated by the wearable. Children in the experimental group will have the wearable's experimental movement functions activated.

Group Type EXPERIMENTAL

WeFun-wearable activated

Intervention Type DEVICE

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.

1 month daily routine program with wefun-wearable desactivated

Children will follow a daily routine program based on goals set by families, which will be initiated by the wearable. Children in the control group will not have experimental functions in their wearables.

Group Type ACTIVE_COMPARATOR

WeFun-wearable desactivated

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No