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

NCT07135791 · tracked via the Priya Life Science Denmark tracker

Sponsor

Copenhagen University Hospital, Rigshospitalet

Phase

Observational

Started

2025-03-26

Last updated

2025-08-22

Condition(s) studied

Fatigue SymptomFatigue IntensityCerebral Palsy (CP)Acquired Brain Injury Including StrokeFatigue, MentalFatigue

Investigational drug(s) / intervention(s)

Real-time monitoring

Real-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.

Study 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

Sex

ALL

Min age

30 Years

Max age

65 Years

Healthy volunteers

Accepted

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)

Primary outcome measure(s)

Ecological Momentary Assessment: "Fatigue item" — 10 times a day over 7 consecutive days
A single item variable: "How tired do you feel right now?" Rated on an 11-point slider scale ranging from 0 (no fatigue) to 10 (severe fatigue).

Trial sites (1)

Facility	City	Region	Status
Neurorehabilitation Research and Knowledge Centre, Rigshospitalet	Glostrup Municipality	Denmark	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07135791 on ClinicalTrials.gov ↗ ← All trials in Denmark