A Feasibility Randomised Controlled Trial of an Online Exercise Programme for Adults With Cerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland
About this trial
Adults with cerebral palsy (CP) often face challenges in accessing exercise programmes that are appropriate for their needs. Barriers such as limited mobility, a lack of tailored options, and restricted access to physiotherapy services can make participation difficult. Exercise is important for improving physical health, mental well-being, and overall quality of life. However, many adults with CP do not have regular opportunities to take part in structured physical activity. This study aims to investigate whether an online exercise programme can serve as an effective and accessible alternative.
The main aim of the study is to assess the feasibility of delivering an online exercise programme for adults with CP. Key areas of focus will include demand, implementation, practicality, adaptability, acceptability, and potential benefits to physical, mental, and social well-being.
A total of 60 adults with CP will be recruited and randomly assigned to one of two groups (30 participants per group). One group will complete an 8-week online exercise and education programme. The second group will receive the same educational materials during the study and will be provided with information about the home exercise programme after the 8-week intervention period. Data will be collected on attendance, completion rates, engagement with exercises, and any reported adverse events. Health-related surveys will be completed before and after the programme to assess any changes. In addition, a selected group of participants from the intervention group will take part in interviews to provide feedback on their experiences.
Findings from this study may support the development of accessible, effective, and person-centred online exercise programmes for adults with CP. Results may help improve future programme design and contribute to better care and support for adults with CP in Ireland.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 and over with cerebral palsy (CP) residing on the island of Ireland.
Individuals of any Gross Motor Function Classification System (GMFCS) level.
Individuals with other associated impairments.
People with mild-to-moderate intellectual disability who can access the online platform and follow study instructions, with or without support.
Disqualifiers
Individuals with severe intellectual disability where sufficient adaptations cannot be made.
Adults with unstable medical conditions.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise and education programme
Other interventionParticipants will complete 8-week online exercise programme consisting of an online exercise class once per week. The exercises will target improving strength, balance and range of movement. In addition, participants will receive educational materials on exercise, nutrition, walking changes, fatigue, optimizing bone health, pain management, mental health, sleep and physical activity maintenance.
control group
Other interventionThe control group will receive educational materials over 8 weeks
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Exercise and EducationExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Physical function
Physical function will be measured using the PROMIS physical function- Short Form 10a scale.
Time frame
Duration of study 2 years2
Mobility
Mobility will be measured using the Functional mobility scale on a scale of 0-6.
Time frame
rolling recruitment over 1.2 years3
Presence of Pain
Pain will be assessed using a self-reported questionnaire, measured as Yes or No with description.
Time frame
Duration of study 2 yearsSecondary outcomes
1
Pain intensity
Pain intensity will be measured using the PROMIS Pain intensity form
Time frame
Duration of study 2 years2
Pain quality
Pain quality will be assessed using the PROMIS Neuropathic Pain Quality 5a and Nociceptive Pain Quality 5a scales, with total scores calculated for each to reflect the severity and type of pain experienced.
Time frame
Duration of study 2 years3
Pain interference
Pain quality will be assessed using the PROMIS Pain interference Short Form-8a, with total scores calculated to reflect the quality of pain experienced.
Time frame
Duration of study 2 years4
Fatigue
Fatigue will be assessed using the PROMIS Fatigue Short Form 13a (FACIT Fatigue) scale, with total scores calculated to reflect the severity of fatigue experienced by participants.
Time frame
Duration of study 2 yearsOther outcomes
1
Practicality
Practicality will be assessed by recording adverse events. Measured as Yes or No with description
Time frame
Duration of study 2 years2
Recruitment rate
This will include recording the total number of people who responded to invitations or advertisements to participate in the study.
Time frame
Duration of study 2 years3
Fidelity to the intervention receipt
Fidelity of intervention receipt will be measured by recording the number of sessions attended by participants in the intervention group throughout the study.
Time frame
Duration of study 2 years4
Fidelity of the intervention content
Fidelity of intervention content will be assessed by self-reported completion of exercises, collected weekly from the intervention group and at follow-up from the control group.
Time frame
Duration of study 2 yearsSponsors and contacts
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Source ClinicalTrials.gov