Monitoring Fatigue In Daily Life In Adults With Cerebral Palsy or Acquired Brain Injury
Recruiting now
Conditions studied: Fatigue Symptom, Fatigue Intensity, Cerebral Palsy (CP), Acquired Brain Injury Including Stroke, Fatigue, Mental, Fatigue
In brief
The goal of this observational study is to learn about levels and patterns of fatigue in adults with cerebral palsy (CP) and acquired brain injury (ABI) in daily life. The main question it aims to answer is: How do adults with CP and ABI experience fatigue in daily life? Researchers will compare data from CP and ABI with healthy volunteers to see if they experience fatigue differently. Participants will: * Monitor their symptoms, mood, and behavior in real-time by completing a brief survey on their mobile phone 10 times a day for seven consecutive days. * Attend a briefing session the day prior to the seven-day period of real-time monitoring. * Wear an accelerometer for the seven-day period. * Complete a daily sleep diary for the seven-day period. * Receive feedback on their real-time monitoring data, sleep and activity data.
Key facts
- Study ID
- NCT07135791
- Run by
- Rigshospitalet, Denmark
- People needed
- 120
- Starts
- 2025-03-26
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2025-08-22
Who can join
Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Score of minimum 4 on the 7-item Fatigue Severity Scale (CP and ABI only)
- Speak, read, and write Danish
- Living in a private residence (i.e., not in institutional care or facilities providing 24-hour assistance)
- Able to walk independently or with assistive devices over short distances
- Able to operate a smartphone independently
- Additional inclusion criteria for CP specifically:
- Self-reported diagnosis of CP
- Gross Motor Function Classification System (GMFCS) level ≤ II
- Communication Function Classification System level ≤ II
- Additional inclusion criteria for ABI specifically:
- Self-reported diagnosis of ABI, including stroke, traumatic brain injury, brain infections, toxins, anoxia, or encephalopathy (transient ischemic attack, concussion or post-concussion syndrome, intracranial tumors, or progressive brain diseases are not included)
- Between three months and two years post-injury
- modified Rankin Scale (mRS) score ≤ 3
You may not qualify if…
- History of other neurological disorders or chronic fatigue syndrome requiring treatment
- Current substance or alcohol abuse
- Night shift work or travel across time zones (1 to 3 zones within the last week or 4 to 6 zones within the last two weeks or at least 7 zones within the last 4 weeks)
Where it is running
- Neurorehabilitation Research and Knowledge Centre, Rigshospitalet — Glostrup Municipality, Denmark (enrolling)
Full record on ClinicalTrials.gov
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