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

Recruiting

• Conditions: Fatigue Symptom; Fatigue Intensity; Cerebral Palsy (CP); Acquired Brain Injury Including Stroke; Fatigue, Mental; Fatigue

• Registration Number: NCT07135791
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Fatigue is a major problem for adults with cerebral palsy (CP) or acquired brain injury (ABI), and contributes to disability, loss of productivity, and poor quality of life.

Qualitative research indicates that fatigue symptoms are dynamic and context-dependent, and the severity of symptoms can fluctuate throughout the day and from day to day.

People living with fatigue may tire more easily, in response to physical or mental exertion, than people without fatigue. Symptoms of fatigue may worsen dramatically and unexpectedly from one moment to the next. It can be very difficult for people to figure out, why they are suddenly overwhelmed by fatigue and to anticipate when symptoms will worsen again.

To help people manage their fatigue, assessment and treatment approaches need to encompass the daily fluctuations and their interaction over time with activities of daily living.

Ecological momentary assessment (EMA) is a well-established method for capturing everyday experiences, including thoughts and behaviors, in their immediate context. As they go about their everyday lives, respondents are prompted multiple times a day, on a mobile device, to answer a brief set of questions about their momentary, "here and now", experience, e.g., "how happy are you right now?". On traditional self-report instruments, such as questionnaires, rating scales, and diaries, respondents are required to recall information or report on their beliefs and attitudes, which introduce risks of bias to the assessment attributable to memory limitations, personal beliefs, and self-perception. By sampling everyday experiences in real-time, EMA reduces these biases and errors.

The longitudinal nature of EMA even allows for assessment of dynamic processes and interactions that occur over short periods of time. Such fine-grained data are crucial for understanding how and why symptoms change during the day and to identify circumstances that may worsen or mitigate fatigue. This may lead to better treatment and symptom management.

A few studies in CP and ABI have demonstrated the feasibility and prospect of using EMA to capture the dynamics of fatigue. However, evidence is scarce regarding factors of everyday life that exacerbate or mitigate fatigue, although this information is essential for effective management strategies. Qualitative research indicates that several potential triggers of fatigue may be similar across CP and ABI.

Primary Objective:

1. To identify patterns of fatigue and antecedents of symptom exacerbation in daily life of adults with CP and ABI.

Secondary Objectives:

2. To compare the dynamics of fatigue across CP, ABI, and neurotypical controls.

3. To identify factors in daily life that correlate with exacerbating fatigue symptoms.

4. To explore how physical activity, rest, and sleep influence fatigue patterns.

Design: We will use an intensive longitudinal observational study design. Participants will be asked to monitor in real-time for seven consecutive days. Notifications will pop up on their smartphone 10 times a day, and participants will be prompted to answer a brief survey about "how they are doing", "what they are doing", "where they are", and "who they are with", when they received the notification.

Participants will wear an accelerometer on their least affected thigh, and they will be asked to complete a sleep diary every morning in the seven-day period. The day prior to real-time monitoring, participants will meet with a research assistant to be instructed in the EMA protocol.

One week after real-time monitoring, participants will be invited to a feedback session, where the results of real-time monitoring of fatigue, activity, and sleep will be presented and discussed.

We will compare three groups of participants: Adults with CP, adults with ABI, and healthy volunteers without neurological conditions.

Participants with CP will be recruited via a public online announcement on the Elsass Foundation's website.

Participants with ABI will be recruited via two specialised brain injury rehabilitation centers (Vejlefjord Rehabilitering and Center for Rehabilitation of Brain Injury).

Healthy volunteers for the control group were initially planned to be recruited via the social network of the participants with CP or ABI. From August 2025, recruitment will be advertised publicly through social media platforms of the Neurorehabilitation Research and Knowledge Centre, Copenhagen University Hospital - Rigshospitalet (including newsletter, LinkedIn, and announcement on the webpage). The call for healthy volunteers will also be promoted through advocacy organizations for individuals with cerebral palsy or acquired brain injury, e.g., via social media platforms or their websites.

Study Timeline

• Study Start: 2025-03-26
• Study First Submitted: 2025-07-29
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Ecological Momentary Assessment "Exhaustion item"	10 times a day over 7 consecutive days	A single item variable: "How exhausted do you feel right now?" Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much).
Ecological Momentary Assessment "Pain item"	10 times a day over 7 consecutive days	A single item variable: "How much pain do you have right now?" Rated on an 11-point slider scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Consensus Sleep Diary (CSD)	1 time a day over 7 consecutive days	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.
SENS motion® activity sensor	7 consecutive days	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.
Ecological Momentary Assessment: "Fatigue domain item"	10 times a day over 7 consecutive days	A single item variable: "How does your fatigue feel right now?" Response categories are: "Primarily physical", "Primarily mental", "Both", "Neither", and "Not relevant"
Ecological Monetary Assessment: "Alert item"	10 times a day over 7 consecutive days	A single item variable: "How alert do you feel right now?". Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much).
Ecological Momentary Assessment "Sleepy item"	10 times a day over 7 consecutive days	A single item variable: "How sleepy do you feel right now?" Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much)
Ecological Momentary Assessment: "Happiness item"	10 times a day over 7 consecutive days	A single item variable: "How happy do you feel right now?" Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much).
Ecological Momentary Assessment: "Sadness item"	10 times a day over 7 consecutive days	A single item variable: "How sad do you feel right now?" Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much).
Ecological Momentary Assessment: "Anxious item"	10 times a day over 7 consecutive days	A single item variable: "How anxious do you feel right now?" Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much).
Ecological Momentary Assessment: "Irritability item"	10 times a day over 7 consecutive days	A single item variable: "How irritable do you feel right now?" Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much).
Ecological Momentary Assessment: "Activity item"	10 times a day over 7 consecutive days	A single item variable: "What were you doing when you received the notification?" Multiple choice response.
Ecological Momentary Assessment "Energy item"	10 times a day over 7 consecutive days	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: "Concentration item"	10 times a day over 7 consecutive days	A single item variable: "How well are you able to concentrate right now?" Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much).
Ecological Momentary Assessment: "Effort item"	10 times a day over 7 consecutive days	A single item variable: "How much of an effort is it to do anything right now?" Rated on an 11-point slider scale ranging from 0 (none at all) to 10 (very much).
Ecological Momentary Assessment: "Physical demand item"	10 times a day over 7 consecutive days	A single item variable: "How physically demanding is the task you were doing?" Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much).
Ecological Momentary Assessment: "Mental demand item"	10 times a day over 7 consecutive days	A single item variable: "How mentally demanding is the task you were doing?" Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much).
Ecological Momentary Assessment: "Motivation item"	10 times a day over 7 consecutive days	A single item variable: "How motivated were you for the task you were doing?" Rated on an 11-point slider scale ranging from 0 (not at all) to 10 (very much).
Ecological Momentary Assessment: "Location item"	10 times a day over 7 consecutive days	A single item variable: "Where were you when you received the notification?" Multiple choice response.
Ecological Momentary Assessment: "Sensory load item"	10 times a day over 7 consecutive days	A single item variable: "How many sensory impressions were present around you when you received the notification?" Rated on a 5-point Likert-type scale: 0 (Very low degree), 1 (Low degree), 2 (Some degree), 3 (High degree), and 4 (Very high degree).
Ecological Momentary Assessment: "Company item"	10 times a day over 7 consecutive days	A single item variable: "Who were with you when you received the notification?" Multiple choice response.

Trial Locations

Locations (1)

Neurorehabilitation Research and Knowledge Centre, Rigshospitalet; 🇩🇰 Glostrup, Denmark