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.
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
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)
All participants will be residing in Denmark. Participants with CP will be recruited nationally via two sites located in the eastern and western part of Denmark, respectively: Glostrup and Kolding. They are not required to have any affiliation with clinical settings or organizations. Healthy volunteers will be recruited via a single site in the eastern part of Denmark (Glostrup). Participants with ABI will be recruited via two specialized rehabilitation centers in the eastern and western part of Denmark: 1. Vejlefjord Rehabilitation, providing both inpatient and outpatient rehabilitation programs for children and adults with functional impairments following brain injury. 2. Center for Rehabilitation of Brain Injury, providing outpatient rehabilitation services for individuals with acquired brain injury.
Cohort
Prospective
Real-time monitoring
Diagnostic testComplete a brief 20-item survey 10 times a day for seven consecutive days, while wearing an accelerometer and completing daily sleep diaries.
Ecological Momentary Assessment: "Fatigue item"
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).
SENS motion® activity sensor
SENS motion® wearable activity sensor is an accelerometer that will be attached to the thigh using a patch. The accelerometer will be used to measure physical activity, sedentary behavior, and sleep. If the participants have any physical impairments, the patch will be worn on the least affected thigh.
Consensus Sleep Diary (CSD)
The Consensus Sleep Diary (CSD) is a self-report 9-item instrument designed to track sleep patterns on a daily basis for typically 1-2 weeks. The questions ask about: (1) the time of getting into bed; (2) the time at which the individual attempted to fall asleep; (3) sleep onset latency; (4) number of awakenings; (5) duration of awakenings; (6) time of final awakening; (7) final rise time; (8) perceived sleep quality, rated on a 5-level scale from 1 (very poor) to 5 (very good); and (9) an additional space for open-ended comments from the respondent. We added two items from the expanded CSD for Morning about napping or dozing during the day: (10) number of naps/dozings; and (11) duration of naps/dozings. Participants are instructed to complete the CSD within one hour of getting out of bed in the morning.
Ecological Momentary Assessment "Energy item"
A single item variable: "How much energy do you have right now?" Rated on an 11-point slider scale ranging from 0 (pictogram of an empty battery) to 10 (pictogram of a full battery).
Ecological Momentary Assessment: "Fatigue domain item"
A single item variable: "How does your fatigue feel right now?" Response categories are: "Primarily physical", "Primarily mental", "Both", "Neither", and "Not relevant"
Fatigue Severity Scale (FSS)
A self-report 9-item questionnaire measuring the impact of fatigue in daily life. The scale provides a total average score of the nine items, ranging from 1 to 7, with 1 indicating no or little experience with functional limitations due to fatigue and 7 indicating severe functional limitations due to fatigue.
The Fatigue Impact and Severity Self-Asssessment (FISSA)
A self-administered 37-item questionnaire. It includes a total fatigue score (the sum of items 1-31), ranging from 31 (low fatigue) to 157 (high fatigue), and two subscales: The Impact Subscale (items 1-17, score range from 17 to 87) and the Management and Activity Modification Subscale (items 18-31, score range from 14 to 70). Higher scores indicate more fatigue. The last 6 items (items 32-37) are a mix of multiple choice and open-ended questions investigating daily fatigue and management that are not included in any scores. The complete FISSA will be administered to participants with cerebral palsy only. The last 6 items will also be administered to participants with acquired brain injury.
Dutch Multifactor Fatigue Scale (DMFS)
The Dutch Multifactor Fatigue Scale (DMFS) is a self-administered questionnaire designed to assess the multidimensional nature of fatigue and coping strategies in individuals with acquired brain injury. DMFS has 38 items scored on a 5-point Likert-type scale ranging from 1 (No, I strongly disagree) to 5 (Yes, I strongly agree). DMFS includes 5 subscales: Impact of Fatigue (score range from 11 to 55), Signs and Direct Consequences of Fatigue (score range from 9 to 45), Mental Fatigue (score range from 7 to 35), Physical Fatigue (score range from 6 to 30), and Coping with Fatigue (score range from 5 to 25). Higher scores indicate more fatigue or worse coping with fatigue. DMFS will be administered to participants with acquired brain injury only.
Pittsburgh Sleep Quality Index (PSQI)
A self-report questionnaire assessing sleep quality over a one-month period. The questionnaire includes 19 self-rated questions and 5 questions rated by the bed partner or roommate, covering different sleep-related factors such as bedtime habits, sleep disturbances, sleep duration, and daytime impairments. The 19 self-rated items are scored from 0 to 3 to create seven component scores, which are added to produce a global PSQI score, ranging from 0 (no difficulty) to 21 (severe difficulty).
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Center for Rehabilitation of Brain Injury (Center for Hjerneskade)
Collaborator
Vejlefjord Rehabilitation
Collaborator
Elsass Foundation
Collaborator
