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

NCT ID: NCT07135791

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-26
• Study Completion Date: 2026-10-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cerebral palsy

Adults with cerebral palsy

Real-time monitoring

Intervention Type: DIAGNOSTIC_TEST

Complete a brief 20-item survey 10 times a day for seven consecutive days, while wearing an accelerometer and completing daily sleep diaries.

Acquired brain injury

Adults with acquired brain injury

Real-time monitoring

Intervention Type: DIAGNOSTIC_TEST

Complete a brief 20-item survey 10 times a day for seven consecutive days, while wearing an accelerometer and completing daily sleep diaries.

Healthy volunteers

Adults without neurological conditions

Real-time monitoring

Intervention Type: DIAGNOSTIC_TEST

Complete a brief 20-item survey 10 times a day for seven consecutive days, while wearing an accelerometer and completing daily sleep diaries.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Ecological Momentary Assessment; Ambulatory assessment

Eligibility Criteria

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

• Self-reported diagnosis of CP
• Gross Motor Function Classification System (GMFCS) level ≤ II
• Communication Function Classification System level ≤ II

• 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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Rehabilitation of Brain Injury (Center for Hjerneskade)

UNKNOWN

Sponsor Role: collaborator

Vejlefjord Rehabilitation

OTHER

Sponsor Role: collaborator

Elsass Foundation

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Frederik Dornonville de la Cour

Postdoc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Norup, Ph.D.

Role: STUDY_DIRECTOR

Neurorehabilitation Research and Knowledge Centre, Rigshospitalet

Locations

Neurorehabilitation Research and Knowledge Centre, Rigshospitalet

Glostrup Municipality, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Frederik Dornonville de la Cour, Ph.D.

Role: CONTACT

fdor0002@regionh.dk

+4538634292

Sun-Hee S Christensen, MSc

Role: CONTACT

sun-hee.skovgaard.christensen.01@regionh.dk

+4538624292

Facility Contacts

Frederik Dornonville de la Cour, Ph.D

Role: primary

fdor0002@regionh.dk

+4538634292

Sun-Hee S Christensen, MSc

Role: backup

sun-hee.skovgaard.christensen.01@regionh.dk

+4538624292

Other Identifiers

p-2023-14839

Identifier Type: -

Identifier Source: org_study_id