NCT07135791 Monitoring Fatigue In Daily Life In Adults With Cerebral Palsy or Acquired Brain Injury
| NCT ID | NCT07135791 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital, Rigshospitalet |
| Condition | Fatigue Symptom |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-03-26 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Contact & Investigator
Anne Norup, Ph.D.
STUDY DIRECTOR
Neurorehabilitation Research and Knowledge Centre, Rigshospitalet
Frequently Asked Questions
Who can join the NCT07135791 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 65 Years, studying Fatigue Symptom. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07135791 currently recruiting?
Yes, NCT07135791 is actively recruiting participants. Contact the research team at fdor0002@regionh.dk for enrollment information.
Where is the NCT07135791 trial being conducted?
This trial is being conducted at Glostrup Municipality, Denmark.
Who is sponsoring the NCT07135791 clinical trial?
NCT07135791 is sponsored by Copenhagen University Hospital, Rigshospitalet. The principal investigator is Anne Norup, Ph.D. at Neurorehabilitation Research and Knowledge Centre, Rigshospitalet. The trial plans to enroll 120 participants.