Clinical trial NCT06872736: Wereables for Upper Limb Functionality in Hemiparesis
Official title: Innovative Use of Wereable Technology for Improving Functionality in Children with Unilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Unilateral Cerebral Palsy
Keywords: children
unilateral cerebral palsy
function
mobility
upper limb
weareable
technology
routines
family centered approach
activity
participation
family
developmental disregard
environmental enrichment
natural environment
quality of life
movement analysis
fatigue
upper extremity
family involvement in research
hemiparesis
cerebral palsy
early intervention
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
Collaborators: name: Complexo Hospitalario Universitario de A Coruña
First posted: 2025-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Selected Physical Therapy Program, wearable, routine program, double blind, contrabalanced randomization
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bimanual performance/functional hand use
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
Secondary outcomes:
measure: Sociodemographic variables
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Upper Extremity Use (UEU) - WeFUN-wearable measure
timeFrame: Baseline, during intervention period, immediately after the intervention and after 2 months follow-up
measure: Asymmetry Index (AI) - WeFUN-wearable measure
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Grip strength
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Static motor fatigability
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Dynamic motor fatigability
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Hand Dexetrity
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Participation measures
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Quality of life measures
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Attention measures
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Self-perceived occupational performance
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Goal attainment
timeFrame: Baseline, immediately after the intervention and after 2 months follow-up
measure: Usability measures
timeFrame: immediately after the intervention
measure: Adherence measures
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Universidade da Coruña
Study officials:
References:
citation: Albrecht EC, Khetani MA. Environmental impact on young children's participation in home-based activities. Dev Med Child Neurol. 2017 Apr;59(4):388-394. doi: 10.1111/dmcn.13360. Epub 2016 Dec 17.
citation: Reid LB, Rose SE, Boyd RN. Rehabilitation and neuroplasticity in children with unilateral cerebral palsy. Nat Rev Neurol. 2015 Jul;11(7):390-400. doi: 10.1038/nrneurol.2015.97. Epub 2015 Jun 16.
citation: Gordon AM, Bleyenheuft Y, Steenbergen B. Pathophysiology of impaired hand function in children with unilateral cerebral palsy. Dev Med Child Neurol. 2013 Nov;55 Suppl 4:32-7. doi: 10.1111/dmcn.12304.
citation: Carton de Tournai A, Herman E, Ebner-Karestinos D, Gathy E, Araneda R, Renders A, De Clerck C, Kilcioglu S, Dricot L, Macq B, Vandermeeren Y, Bleyenheuft Y. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Infants With Unilateral Cerebral Palsy: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2445133. doi: 10.1001/jamanetworkopen.2024.45133.