Wereables for Upper Limb Functionality in Hemiparesis (WeFun)

Universidade da Coruña

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Unilateral Cerebral Palsy

Treatments: Device: WeFun-wearable activated; Device: WeFun-wearable desactivated

Study type: Interventional

Funder types: Other

Identifiers

NCT06872736

PID2021-126782OA-I00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

1 month daily routine program with wefun-weareable activated

Experimental group

Description:

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.

Treatment:

Device: WeFun-wearable activated

1 month daily routine program with wefun-wearable desactivated

Active Comparator group

Description:

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.

Treatment:

Device: WeFun-wearable desactivated