Actively Recruiting
Real-Time Monitoring of Fatigue in Daily Life Among Adults with Cerebral Palsy or Acquired Brain Injury: An Observational Study
Led by Rigshospitalet, Denmark · Updated on 2025-08-22
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
C
Center for Rehabilitation of Brain Injury (Center for Hjerneskade)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how adults with cerebral palsy (CP) and acquired brain injury (ABI) experience fatigue throughout their daily lives. It compares fatigue patterns and levels in adults with CP and ABI to those in healthy volunteers to find out if their experiences differ. Fatigue is a major issue for these groups, affecting their quality of life and daily functioning, and this study seeks to capture the fluctuations and triggers of fatigue in real-time. Participants will be monitored using a method called Ecological Momentary Assessment (EMA), which involves answering brief surveys on a mobile phone 10 times a day for seven days. During this period, they will also wear an accelerometer to track movement and complete a daily sleep diary. Before starting the monitoring week, participants attend a briefing session, and after the monitoring, they receive personalized feedback on their fatigue, activity, and sleep data. Throughout the study, participants will report on their symptoms, mood, activities, and social context in real-time. Researchers will analyze these reports alongside activity and sleep data to identify patterns and factors affecting fatigue. The primary measure is the fatigue level recorded multiple times daily over the monitoring week. The study includes adults aged 30 to 65 years and involves feedback sessions to discuss individual data. Participation lasts about two weeks, including briefing, monitoring, and feedback.
CONDITIONS
Brief Title
Monitoring Fatigue In Daily Life In Adults With Cerebral Palsy or Acquired Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Score at least 4 on the 7-item Fatigue Severity Scale (for CP and ABI participants only)
- Speak, read, and write Danish
- Live in a private residence, not in institutional care
- Able to walk independently or with assistive devices over short distances
- Able to use a smartphone independently
- For cerebral palsy: self-reported diagnosis of CP
- For cerebral palsy: Gross Motor Function Classification System level II or less
- For cerebral palsy: Communication Function Classification System level II or less
- For acquired brain injury: self-reported diagnosis including stroke, traumatic brain injury, brain infections, toxins, anoxia, or encephalopathy
- For acquired brain injury: between 3 months and 2 years after injury
- For acquired brain injury: modified Rankin Scale score 3 or less
You will not qualify if you...
- History of other neurological disorders or chronic fatigue syndrome requiring treatment
- Current substance or alcohol abuse
- Night shift work or recent travel across time zones (1-3 zones within the last week, 4-6 zones within the last two weeks, or at least 7 zones within the last 4 weeks)
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for instruction in the monitoring protocol
Duration - 7 consecutive days
Participants complete real-time monitoring of fatigue and related factors using a smartphone survey and wearable accelerometer over seven consecutive days.
Notifications to answer a brief survey 10 times a day; daily completion of a sleep diary
Duration - 1 day, approximately 1 week after monitoring
Participants attend a feedback session where results from the real-time monitoring of fatigue, activity, and sleep are presented and discussed.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Neurorehabilitation Research and Knowledge Centre, Rigshospitalet
Glostrup Municipality, Denmark, 2600
Actively Recruiting
Research Team
F
Frederik Dornonville de la Cour, Ph.D.
S
Sun-Hee S Christensen, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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