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Real-Time Monitoring of Fatigue In Daily Life Among Adults With Cerebral Palsy or Acquired Brain Injury: An Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Denmark
Neurorehabilitation Research and Knowledge Centre, Rigshospitalet
RECRUITING
Glostrup Municipality
Contact Information
Primary
Frederik Dornonville de la Cour, Ph.D.
fdor0002@regionh.dk
+4538634292
Backup
Sun-Hee S Christensen, MSc
sun-hee.skovgaard.christensen.01@regionh.dk
+4538624292
Time Frame
Start Date: 2025-03-26
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 120
Treatments
Cerebral palsy
Adults with cerebral palsy
Acquired brain injury
Adults with acquired brain injury
Healthy volunteers
Adults without neurological conditions
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark
Collaborators: Center for Rehabilitation of Brain Injury (Center for Hjerneskade), Elsass Foundation, Vejlefjord Rehabilitation

This content was sourced from clinicaltrials.gov