An interventional study of A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions. and A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions in Children With Cerebral Palsy Who Are Ambulant and Cerebral Palsy GMFCS-ER I-II, sponsored by Lund University. Recruiting at 1 site in Sweden. Open to participants aged 10 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by Lund University · Not applicable, Interventional, and Treatment
Among 19 studies in Cerebral Palsy with a site in Sweden — 9 open to participants now, 10 under way, none of them phase 3. Cerebral Palsy · Sweden.
Among the 19 studies in Cerebral Palsy with a site in Sweden, this one is the 6th largest by planned enrollment of the 10 interventional ones, is the only one that started in 2025, is one of 9 with no phase, and was the 18th registered.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 20 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →9 of the 19 studies in Cerebral Palsy with a site in Sweden are open now, in 1 country. Each count lists the studies.
Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.
This study: 10 Years to 16 Years · all sexes · healthy volunteers too.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2025.
Median enrollment 28 across the 10 interventional studies, 150 across the 9 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
2 of 19 have an industry lead sponsor. The 10 most frequent:
Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.
Lund University has 2 studies filed under Cerebral Palsy — fewer than ten, so there is no comparison to draw.
6 of the studies in Cerebral Palsy with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05867940Region SkaneEffects of Physical Activity on Prescription (PAP) as a Health-enhancing Intervention in People With Disabilities | 2026-12 |
| NCT05497609Eva PontenThe Muscle in Children With Cerebral Palsy - Longitudinal Exploration of Microscopic Muscle Structure. | 2026-12-15 |
| NCT07374432Karolinska InstitutetFull Speed Ahead: For Joyful Movement and Health | 2026-12-30 |
| NCT07025694Lund UniversityExercise Training Among Children With Cerebral Palsy to Increase Health and Well-being - A Feasibility Study | 2026-12-31 |
| NCT05901259Otto Bock Healthcare Products GmbHThe EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes | 2027-08-01 |
Among the 19 studies in Cerebral Palsy with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
The use of eHealth in children with cerebral palsy (CP) holds promise to increase participation in exercise. eHealth, has shown to increase accessibility to appropriate healthcare professionals as well as reduces time- and energy consuming transportation to/from physical appointments[5]. In children with CP reduced transportation to and from appointments, increased access to appropriate healthcare s professionals have shown to increase exercise.
However, the knowledge on how eHealth can support children with CP to participate in exercise is scarce and to the best of our knowledge there are no studies studying eHealth to increase exercise in children with CP. If HOME-EX research project is successful, we will unravel knowledge that will facilitate implementation of prescription of targeted, personalized exercise regimes to children with CP to enhance health and wellbeing and furthermore set a healthy lifestyle.
PURPOSE AND AIMS
The overall goal of the HOME-EX project is to develop, feasibility test, pilot the efficacy and map the conditions for future implement an eHealth application to support participation in exercise at home in children with CP who are ambulant (CP-A). The specific aims are:
Aim 1: From a pre-exciting eHealth-solution develop an application for Android-based tablet supporting exercise in the home of the children with CP-A in co-creation with children, family caregivers, professional caregivers, sports professionals and researchers.
Aim 2: Develop exercise sessions, as online supervised session and pre-video recorded sessions in co-creation with children, family caregivers, professional caregivers, sports professionals and researchers, to be delivered by the eHealth-solution.
Aim 3: To study the feasibility of the delivery of the exercise sessions from the eHealth-solution.
PROJECT DESCRIPTION Cerebral palsy (CP) is the most common physical disability in childhood, approximately 1.6/1000 children have CP with affected muscle tone, movement and motor skills, often accompanied by pain, epilepsy and intellectual, communicational and behavioural impairment.
The degree of motor impairment in CP is extremely variable and classified with the 5-level Gross Motor Function Classification System Expanded \& Revised (GMFCS-E\&R). Children with CP-A (GMFCS-E\&R level I-II) can either walk and/ stand independently.
Project management Since children are non-autonomous, the common point of departure for our research is the family; lifestyle changes as well as interventions must be implemented through the family. Feasibility testing aims to analyse clinical, procedural, and methodological uncertainties of the exercise testing and the exercise training interventions designed in co-creation with stakeholders. If no major changes are made to the study design and/or the intervention these children will be included into the piloting phase.
Recruitment In total, 20 children - 10 children with CP-A and 10 who are TD as healthy controls - aged between 10 to 16 years old will be recruited. The children in the two groups will be matched for age, BMI, and physical activity level.
Study 1: Addressing aim 1-2 - Development of an exercise-application Methodology: Workshops to further develop the eHealth app: Four separate workshops will then be conducted to discuss the functions and the setup of communication of the initial prototype, as well as how to deliver the exercise sessions and what they preferably may contain. Workshop 1 will consist of 4-6 children children with CP-A and TD. Workshop 2 will consist of family caregivers. Workshop 3 of professional caregivers as physiotherapists and workshop 4 of sport professionals as personal trainers. The workshops will employ a participatory approach, enabling active contributions from participants and be facilitated by researchers from the research group. After the workshops, the eHealth app will be updated by a technician based on the feedback received.
Study 2: Addressing aim 3 - Feasibility testing of an exercise-application Methodology: Four children in each group, in total eight children, will take part in the feasibility analysis. During the first three weeks will the children be supervised at schedule timepoints through an eHealth solution and during the last three weeks the children follows pre-recorded exercise sessions at a suitable time for the family.
After the first 6 weeks of exercise training procedural, clinical and methodological uncreates will be analysed. Feedback from the participants and their family-caregivers, will be collected through semi-structured interviews to evaluate the feasibility of the exercise training intervention. Depending on the findings during the feasibility testing, the exercise training intervention may change.
DATA ANALYS AND STATISTIC A mixed method approach will be used to meet the aims of the project and collect both quantitative and qualitative data.
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:
Children with CP-A defined classified with the 5-level Gross Motor Function Classification System Expanded \& Revised (as GMFCS-E\&R) as GMFCS-E\&R I-II.
Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions. · Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions · Other: Moderate Intensity Continues Training · Other: High intensity interval training
Ambulant children who are TD with no other neurological diagnoses, metabolic diagnoses, orthopaedic disabilities, asthma, heart diseases, cognitive impairment, or indigestion of regular medication.
Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions. · Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions · Other: Moderate Intensity Continues Training · Other: High intensity interval training
Feasibility, acceptability and usability testing of delivering home-based exercise MICT and HIIT via a Vidoe-call at fixed time-points. Tuesday, Thursday, Saturday during the 3 week-period of supervision via zoom.
Also known as: Vidoecall exercise
Feasibility, acceptability and usability testing of delivering home-based exercise MICT and HIIT via a pre-recorded videos at convenient time-point with at least one day in between during the periods of video-supervision
Also known as: Pre-recorded exercise
The MICT exercise training on a spinning-bike will consist of moderate intensity-longer (60%Wpeak) duration exercise carried out 3 times per week. Tuesday, Thursday, Saturday during the 3 week-period of supervision via zoom, and at time-point with at least one day in between during the periods of video-supervision. Exercise will consist of continuous biking at an individualized workload based on pre-exercise testing, for a total time of 30 minutes.
Also known as: MICT
The HIIT exercise training on a spinning-bike will begin by using a protocol consisting of bouts of high-intensity (95%Wpeak) exercise lasting for 60 seconds. These bouts will be interspersed by 4 minutes of low intensity exercising (40%Wpeak). There will be 5 bouts per session. Exercise will consist of continuous biking at individualized workloads based on pre-exercise testing. The exercise will be carried out 3 times per week. Tuesday, Thursday, Saturday during the 3 week-period of supervision via zoom, and at time-point with at least one day in between during the periods of video-supervision.
Also known as: HIIT
Complaiance to the exercise regim
Number of exercise sessions performed
Time frame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Variance in the predefinde workload
Coefficient of variance during each exercise session assessed by the spinning bike.
Time frame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Number of adversed events due to illness
Number registered in the ehealth app
Time frame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Number of adverse avents due to technical issues
Number registered in the ehealth app
Time frame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Maximal exercise capacity
Indirect calorimetry will be used during a maximal incremental exercise test. The exercise test will be initiated by cycling on a cycle ergometer for 6 minutes at 30 W, followed by an increase of 10W/minute until exhaustion. The test will performed before and after each exercise period. Exercise tests will be performed on a cycle ergometer (Monark 936, Monark Exercise AB, Vansbro, Sweden). An airtight mask covering the mouth and nose will be worn to measure breath-by-breath of VO2 and VCO2, for determination of maximal oxygen consumption (VO2peak), maximal workload (WRpeak), oxygen kinetics and Respiratory Exchange Ratio (RER) (Oxycon Mobile, Jaeger, Germany). Heart rate will be recorded continuously throughout the test (Polar, Finland).
Time frame: From inclusion in the study undtil the last exercise test in total 20 weeks.
Experiance
Semi-structured interviews
Time frame: From inclusion in the study until the last exercise test in total 20 weeks.
Usability
Usability questinnary
Time frame: From inclusion in the study until the last exercise test in total 20 weeks.
Plan to share: No — A small study group with risk of identification of individuals
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 19 months is above that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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