Monitoring daily fatigue in adults with cerebral palsy or acquired brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses ecological momentary assessment to capture momentary fatigue, mood, and behavior by prompting participants on their smartphones 10 times daily for seven consecutive days. Participants will attend a briefing, wear an accelerometer, complete a daily sleep diary, and receive feedback combining real-time reports with sleep and activity data. Researchers will compare patterns from adults with CP and ABI to healthy volunteers to identify differences in daily fatigue dynamics. The aim is to map fluctuations and context-dependent triggers that could inform personalized management strategies.

Why it matters

Who can join: the full rules

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)

Where it's running

• Neurorehabilitation Research and Knowledge Centre, Rigshospitalet
  Glostrup Municipality, Denmark Recruiting

Study contacts

• Study coordinator: Frederik Dornonville de la Cour, Ph.D.
• Email: fdor0002@regionh.dk
• Phone: +4538634292

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.