Wereables for Upper Limb Functionality in Hemiparesis
ConditionUnilateral Cerebral Palsy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age3-8
SponsorUniversidade da Coruña
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
WeFun-wearable activated
Device1 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.
WeFun-wearable desactivated
Device1 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: 1 month daily routine program with wefun-weareable activatedExperimental treatment 1 intervention
Group B: 1 month daily routine program with wefun-wearable desactivatedActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, immediately after the intervention and after 2 months follow-upSecondary outcomes
1
Sociodemographic variables
Those sociodemographic and clinical variables that may influence the data obtained will be recorded. These are: age, sex, medical diagnosis, therapeutic and medical interventions performed, manual ability classification system (MACS) level, medical complications, medication and vision/hearing/behavioral problems.
Time frame
Baseline, immediately after the intervention and after 2 months follow-up2
Upper Extremity Use (UEU) - WeFUN-wearable measure
Activity recorded across six axes of the accelerometer and gyroscope of the wearable will be combined and processed to obtained Upper Extremity Use (UEU) variable which will represent the quantity of upper extremity movement (mean activity counts per second over an entire monitored activity). This activity will be recorder during all the protocol (assessments and intervention period).
Time frame
Baseline, during intervention period, immediately after the intervention and after 2 months follow-up3
Asymmetry Index (AI) - WeFUN-wearable measure
During AHA assessment, UEU will be extracted separately for both the dominant and non-dominant (or affected) hand and calculated an Asymmetry Index (AI) following the Edinburgh Inventory formula to check how much each arm contributes to the activity. This measurement will be recorded only at the laboratory assessments.
Time frame
Baseline, immediately after the intervention and after 2 months follow-up4
Grip strength
Grip strength is assessed with Biometrics E-LINK H-500 Hand Kit (dynamometer). children performed three MVC with the grip dynamometer with each hand. After each MVC, a 30-s rest was provided. The mean of the three trials is used.
Time frame
Baseline, immediately after the intervention and after 2 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade da Coruña
Lead sponsor
Complexo Hospitalario Universitario de A Coruña
Collaborator
Source ClinicalTrials.gov