RecruitingNCT07135791

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


Sponsor

Rigshospitalet, Denmark

Enrollment

120 participants

Start Date

Mar 26, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 30 YearsMax Age: 65 Years

Inclusion Criteria11

  • 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
  • Self-reported diagnosis of CP
  • Gross Motor Function Classification System (GMFCS) level ≤ II
  • Communication Function Classification System level ≤ II
  • 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 Criteria3

  • 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)

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Interventions

DIAGNOSTIC_TESTReal-time monitoring

Complete a brief 20-item survey 10 times a day for seven consecutive days, while wearing an accelerometer and completing daily sleep diaries.


Locations(1)

Neurorehabilitation Research and Knowledge Centre, Rigshospitalet

Glostrup Municipality, Denmark

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NCT07135791


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