Wereables for Upper Limb Functionality in Hemiparesis

NCT06872736 | Recruiting Phase 2

• 1 other identifier: PID2021-126782OA-I00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Bimanual performance/functional hand use

  The Assisting Hand Assessment (AHA) evaluates the spontaneous use of the more affected upper limb during bimanual activities. For these assessments a semi-structured play session with standardized toys and materials, that require the use of both hands, is performed and video-recorded. Subsequently, 20 items are scored in a rating range of 4 points, and the sum of scores in AHA may vary between 22 and 88 points. Through Rasch analysis this ordinal scale is transformed into AHA units ranging from 0 to 100 to obtain the final score. The AHA has shown to be a reliable and valid assessment for children and adolescents with unilateral cerebral palsy.

  Baseline, immediately after the intervention and after 2 months follow-up

Secondary Outcomes (14)

• Sociodemographic variables

  Baseline, immediately after the intervention and after 2 months follow-up

• Upper Extremity Use (UEU) - WeFUN-wearable measure

  Baseline, during intervention period, immediately after the intervention and after 2 months follow-up

• Asymmetry Index (AI) - WeFUN-wearable measure

  Baseline, immediately after the intervention and after 2 months follow-up

• Grip strength

  Baseline, immediately after the intervention and after 2 months follow-up

• Static motor fatigability

  Baseline, immediately after the intervention and after 2 months follow-up

Study Arms (2)

1 month daily routine program with wefun-weareable activated

EXPERIMENTAL

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.

Device: WeFun-wearable activated

1 month daily routine program with wefun-wearable desactivated

ACTIVE COMPARATOR

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.

Device: WeFun-wearable desactivated

Interventions

WeFun-wearable activated 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-weareable activated

WeFun-wearable desactivated 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.

1 month daily routine program with wefun-wearable desactivated

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade da Coruña: lead
• Complexo Hospitalario Universitario de A Coruña: collaborator

Study Sites (1)

Universidade da Coruña

A Coruña, A Coruña, 15006, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 27988938 BACKGROUND

• 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.

  PMID: 26077839 BACKGROUND

• 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.

  PMID: 24237277 BACKGROUND

• 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.

  PMID: 39556397 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Fatigue; Paresis; Cerebral Palsy

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Verónica Robles García, PhD

CONTACT

+34 981167000; veronica.robles@udc.es

Irene González Eiroa, MsC

CONTACT

+34 981167000; irene.gonzalez.eiroa@udc.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 12, 2025
• Study Start: June 7, 2024
• Primary Completion: September 14, 2024
• Study Completion (Estimated): December 20, 2026
• Last Updated: March 12, 2025

Record last verified: 2024-03

Locations

ES (1)