Clinical trial NCT07025694: Exercise Training Among Children With Cerebral Palsy to Increase Health and Well-being - A Feasibility Study
Official title: Feasibility Testing of a Homebased Exercise Intervention in Children With Cerebral Palsy Who Are Ambulant - The HOME-EX Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children With Cerebral Palsy Who Are Ambulant
Cerebral Palsy GMFCS-ER I-II
Keywords: Children
Cerebral Palsy
Exercise
Feasibility
MICT
HIIT
eHealth
Home based exercise
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* children with CP-A defined as GMFCS-E\&R I-II
* children who are TD and not participating in any regular and planned leisure time physical exercise will be included in the study.

Exclusion Criteria:

* Ambulant children with CP walking with a walking aid (GMFCS-E\&R III);
* ambulant children who are TD with other neurological diagnoses, metabolic diagnoses, orthopaedic disabilities, asthma, heart diseases, cognitive impairment, or indigestion of regular medication.

Primary outcomes:
measure: Complaiance to the exercise regim
timeFrame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Secondary outcomes:
measure: Variance in the predefinde workload
timeFrame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
measure: Number of adversed events due to illness
timeFrame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
measure: Number of adverse avents due to technical issues
timeFrame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
measure: Maximal exercise capacity
timeFrame: From inclusion in the study undtil the last exercise test in total 20 weeks.
Other outcomes:
measure: Experiance
timeFrame: From inclusion in the study until the last exercise test in total 20 weeks.
measure: Usability
timeFrame: From inclusion in the study until the last exercise test in total 20 weeks.
Locations:
city: Lund
country: Sweden
facility: Medical Faculty, Lund University
state: Scania
Study officials:
affiliation: Department of Health Sciences, Medical Faculty, Lund Univeristy, Sweden
name: Åsa B Tornberg, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: