Status:
RECRUITING
Monitoring Fatigue In Daily Life In Adults With Cerebral Palsy or Acquired Brain Injury
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Center for Rehabilitation of Brain Injury (Center for Hjerneskade)
Vejlefjord Rehabilitation
Conditions:
Fatigue Symptom
Fatigue Intensity
Eligibility:
All Genders
30-65 years
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 an...
Detailed Description
Fatigue is a major problem for adults with cerebral palsy (CP) or acquired brain injury (ABI), and contributes to disability, loss of productivity, and poor quality of life. Qualitative research indi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 26 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07135791
Start Date
March 26 2025
End Date
October 31 2026
Last Update
August 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Neurorehabilitation Research and Knowledge Centre, Rigshospitalet
Glostrup Municipality, Denmark, 2600