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

NCT07135791 | Recruiting

• 1 other identifier: p-2023-14839
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cerebral palsy; Acquired brain injury; ecological momentary assessment; experience sampling method; real-time monitoring; Fatigue; Real-time fatigue

Outcome Measures

Primary Outcomes (1)

• 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).

  10 times a day over 7 consecutive days

Secondary Outcomes (21)

• SENS motion® activity sensor

  7 consecutive days

• Consensus Sleep Diary (CSD)

  1 time a day over 7 consecutive days

• Ecological Momentary Assessment "Energy item"

  10 times a day over 7 consecutive days

• Ecological Momentary Assessment: "Fatigue domain item"

  10 times a day over 7 consecutive days

• Ecological Monetary Assessment: "Alert item"

  10 times a day over 7 consecutive days

Other Outcomes (26)

• Fatigue Severity Scale (FSS)

  Baseline

• The Fatigue Impact and Severity Self-Asssessment (FISSA)

  Baseline

• Dutch Multifactor Fatigue Scale (DMFS)

  Baseline

Study Arms (3)

Cerebral palsy

Adults with cerebral palsy

Diagnostic Test: Real-time monitoring

Acquired brain injury

Adults with acquired brain injury

Diagnostic Test: Real-time monitoring

Healthy volunteers

Adults without neurological conditions

Diagnostic Test: Real-time monitoring

Interventions

Real-time monitoring 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.

Also known as: Ecological Momentary Assessment, Ambulatory assessment

Acquired brain injury; Cerebral palsy; Healthy volunteers

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Center for Rehabilitation of Brain Injury (Center for Hjerneskade): collaborator
• Vejlefjord Rehabilitation: collaborator
• Elsass Foundation: collaborator

Study Sites (1)

Neurorehabilitation Research and Knowledge Centre, Rigshospitalet

Glostrup Municipality, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Fatigue; Cerebral Palsy; Mental Fatigue; Brain Injuries

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Anne Norup, Ph.D.

  Neurorehabilitation Research and Knowledge Centre, Rigshospitalet

  STUDY DIRECTOR

Central Study Contacts

Frederik Dornonville de la Cour, Ph.D.

CONTACT

+4538634292; fdor0002@regionh.dk

Sun-Hee S Christensen, MSc

CONTACT

+4538624292; sun-hee.skovgaard.christensen.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 22, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

DK (1)