NCT07135791Recruiting
Monitoring Fatigue In Daily Life In Adults With Cerebral Palsy or Acquired Brain Injury
Real-Time Monitoring of Fatigue In Daily Life Among Adults With Cerebral Palsy or Acquired Brain Injury: An Observational Study
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 29 Jul 2025
- Start date
- 26 Mar 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Stroke
- NCT number
- NCT07135791
What you commit to
- Study type: Observational
- Planned participants: 120
- From 26 Mar 2025 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of other neurological disorders or chronic fatigue syndrome requiring treatment
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 30 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurorehabilitation Research and Knowledge Centre, Rigshospitalet Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.