Monitoring daily fatigue 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
This project will try to capture how often and how intense fatigue is for adults with cerebral palsy or acquired brain injury by asking them to report symptoms on their phone multiple times a day.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Glostrup Municipality) |
| Trial ID | NCT07135791 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with self-reported cerebral palsy (GMFCS ≤ II, CFCS ≤ II) or acquired brain injury (3 months–2 years post-injury, mRS ≤ 3) who score at least 4 on the Fatigue Severity Scale, speak/read/write Danish, live in private residences, can walk short distances, and can operate a smartphone independently are ideal candidates.
Not a fit: People living in institutional care, those with severe mobility or communication impairments, non‑Danish speakers, individuals unable to use a smartphone, or patients with excluded types or timelines of brain injury are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians and patients tailor fatigue management by identifying daily patterns and triggers of worsening fatigue.
How similar studies have performed: Ecological momentary assessment has been successfully used to capture momentary symptoms in other conditions, though its focused application to fatigue in CP and early ABI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Glostrup Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.