A Phase 2/3 interventional study of WeFun-wearable activated and WeFun-wearable desactivated in Unilateral Cerebral Palsy, sponsored by Universidade da Coruña. Recruiting at 1 site in Spain. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Universidade da Coruña · Phase 2/3, Interventional, and Treatment
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.
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Universidade da Coruña is the lead sponsor of 33 studies on the registry; 8 are open to participants now.
Compared within Motor Activity, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Families can be retired from the study after starting if:
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
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
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 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.
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-up
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-up
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-up
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-up
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-up
Static motor fatigability
Assessed with Biometrics E-LINK H-500 Hand Kit (dynamometer). Static motor fatigability will be measured during a 30-second sustained maximal contraction using the grip dynamometer. This measurement will be repeated three times. Static motor fatigability will be quantified with 2 outcome measures: mean force (Fmean) and the static fatigue index. First, the peak force within the first 10 seconds was identified, and only the curve after this peak was used in the calculations. For Fmean, the remaining time was divided into 3 equal parts, and Fmean was calculated for the first and last parts of the curve. For the SFI, the part of the curve before the peak force was excluded from the calculation. Within the remaining curve, the area under the force-time curve and a hypothetical area under the force-time curve were calculated. The hypothetical area under the force-time curve mimics a situation in which strength would have been sustained at the maximum level during the trial and no
Time frame: Baseline, immediately after the intervention and after 2 months follow-up
Dynamic motor fatigability
Assessed with Biometrics E-LINK H-500 Hand Kit (dynamometer). Dynamic motor fatigability will be measured while the child had to squeeze repeatedly as hard and fast as possible during a 30-second period. The measurement will be successful if the child repeatedly squeezed over the entire 30 seconds regardless of the frequency (Brauers 2022). Three trials of this measurement will be performed. Dynamic motor fatigability was quantified by Fmean and the number of peaks (Npeaks). The 30-second force-time curve was divided into 3 equal parts (10 seconds each), and Fmean and Npeaks were calculated for the first and third parts. A decrease in Fmean and/or a decrease in Npeaks between the first and third parts indicated higher motor fatigability.
Time frame: Baseline, immediately after the intervention and after 2 months follow-up
Hand Dexetrity
Box and Block Test (BBT) will be used for measuring hand dexterity by using two compartment box containing 150 blocks. The test includes grasping, moving, and releasing wooden blocks from one side to the other. The score was recorded for 1 minute as the number of blocks passed over the wooden partition
Time frame: Baseline, immediately after the intervention and after 2 months follow-up
Participation measures
Participation and Environment Measure (Young Children YC-PEM, for 3- to 5-year-old participants; Children PEM-CY, for-5 to 7-years-old participants) will be administered. Young Children Participation and Environment Measure (YC-PEM) The YC-PEM and PEMCY analyze the child's participation in different contexts, as well as the characteristics and resources of the environment and it´s implication on participation in children with or without disabilities. It´s a questionnaire, that families respond, and which also allows to know their desire of change, and different strategies they use to optimize the child's participation in their activities of daily life. Scores are calculated for each setting through: 1) The average of all frequency ratings (range = 0-7) are used to calculate frequency; 2) The average of all involvement ratings (range = 1-5) are used to calculate level of involvement; 3) The number of items scored as "yes, change desired" are added, divided by the total number o
Time frame: Baseline, immediately after the intervention and after 2 months follow-up
Quality of life measures
The Pediatric Quality of Life Inventory (PedsQL) cerebral palsy and multidimensional fatigue module, parental version is used. It´s a questionnaire that assesses the quality of life of children from 2 to 18 years. It contains a specific module for children with cerebral palsy. Parents can make the report from 2 to 18 years and assessed the perceptions of parents about their children's HRQOL. The scale contains 35 items and covers aspects of daily activities, school, movement and balance, pain, fatigue, eating activities, speech and communication. The scientific literature relating to PedsQL supports the reliability, validity, and sensitivity of the PedsQL in children with cerebral palsy.
Time frame: Baseline, immediately after the intervention and after 2 months follow-up
Attention measures
Teddy Bear Cancellation Test will be use to measure selective attention and hemineglect in children with unilateral cerebral palsy. A digital version of Teddy Bear is used to obtain more data of the assessment.
Time frame: Baseline, immediately after the intervention and after 2 months follow-up
Self-perceived occupational performance
The Canadian Occupational Performance Measure (COPM) will be used to assess the children's self-perceived occupation performance over different categories, including self-care, leisure and productivity. The parents or caregiver rates performance and satisfaction for each functional goal on a ten point ordinal scale, where 1 = "not able to do it all"/"not satisfied at all" and 10 = "able to do it extremely well"/"extremely satisfied".
Time frame: Baseline, immediately after the intervention and after 2 months follow-up
Goal attainment
Goal attainment will be objectified using the Goal Attainment Scale (GAS) for at least two individualized therapy goals. The GAS enables the conversion of goal attainment on a 5-point scale into t-scores. The score for each functional outcome ranges from -3 to 2. The participant's baseline performance is represented by a score of -2. Improvements in functional goal performance correspond to scores ranging from -1 to +2, with score 0 being the expected outcome.
Time frame: Baseline, immediately after the intervention and after 2 months follow-up
Usability measures
Subjective Usability Scale (SUS), a Likert-type scale with questions about effectiveness (can users achieve their objectives), efficiency (how much effort is expending in achieving the objectives) and satisfaction while using the WeFun-wearable.
Time frame: immediately after the intervention
Adherence measures
In terms of adherence we will register number of weeks participating in the intervention, number and type of activities performed and possible dropouts. For checking acceptability and safety we will register parents´ answers some questions using a Likert-type scale.
Time frame: immediately after the intervention
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidade da Coruña