Actively Recruiting

Age: 30Years - 65Years
All Genders
Healthy Volunteers
NCT07135791

Monitoring Fatigue In Daily Life In Adults With Cerebral Palsy or Acquired Brain Injury

Led by Rigshospitalet, Denmark · Updated on 2025-08-22

120

Participants Needed

1

Research Sites

83 weeks

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

C

Center for Rehabilitation of Brain Injury (Center for Hjerneskade)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Monitoring Fatigue In Daily Life In Adults With Cerebral Palsy or Acquired Brain Injury

Who Can Participate

Age: 30Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (not in institutional care or 24-hour assistance facilities)
  • Able to walk independently or with assistive devices over short distances
  • Able to operate a smartphone independently
  • Self-reported diagnosis of cerebral palsy
  • Gross Motor Function Classification System level 64 II (for CP participants)
  • Communication Function Classification System level 64 II (for CP participants)
  • Self-reported diagnosis of acquired brain injury including stroke, traumatic brain injury, brain infections, toxins, anoxia, or encephalopathy
  • Between three months and two years post-injury (for ABI participants)
  • Modified Rankin Scale score 64 3 (for ABI participants)
Not Eligible

You will not qualify if you...

  • History of other neurological disorders or chronic fatigue syndrome requiring treatment
  • Current substance or alcohol abuse
  • Night shift work or travel across time zones (1-3 zones within the last week, 4-6 zones within the last two weeks, or at least 7 zones within the last 4 weeks)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Neurorehabilitation Research and Knowledge Centre, Rigshospitalet

Glostrup Municipality, Denmark, 2600

Actively Recruiting

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Research Team

F

Frederik Dornonville de la Cour, Ph.D.

CONTACT

S

Sun-Hee S Christensen, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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