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OpenTrials
Completed

NCT Number: NCT06513377

Evaluating and Monitoring Physical Fatigue While Performing Functional Activities

Fatigue is a critical health parameter in older adults and stroke patients and is associated with negative health outcomes. Current assessment tools predominantly focus on walking related fatigue, neglecting other activities of daily living (ADLs). This study aims to fill this gap by developing a standardized, laboratory-based fatigue protocol that includes a broader range of ADLs, providing a more comprehensive fatigue assessment that's in line with the WHO vision of healthy ageing.

The aim of this study is to evaluate a lab-based fatigue protocol and to unravel the relationship between physiological or movement data and perceived fatigue.

Participants will take part in three separate measurement moments, during which they will execute a performance task that induces fatigue. In addition, relevant sensors will be used to collect meaningful data.

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Key information

Conditions

Stroke Atrophy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Fatigue Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brubotics Rehabilitation Research Center

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Stroke survivors:

Inclusion criteria

  • > 18 years old
  • ≥ 3 months ago stroke diagnosis
  • FAC levels 3-5

Exclusion criteria

  • Severe problems with speech or memory which prevents the participant to understand or follow instruction
  • Co-morbidities that could influence the task execution and collected data

Older adults with sarcopenia:

Inclusion:

  • > 65 years old
  • Grip strength: < 27 kg (man) or < 16 kg (woman)
  • Be mobile independently

Exclusion:

  • Severe problems with speech or memory which prevents the participant to understand or follow instruction
  • Co-morbidities that could influence the task execution and collected data

Healthy individuals:

Inclusion:

  • > 18 years old
  • Healthy physical and medical condition

Exclusion:

  • Physical injury or disorder that doesn't allow good physical performance

Treatment and study plan

Performance test

Other

The participant will be asked to execute a protocol in the movement lab that induces progressive feelings of fatigue. This protocol includes a sequence of relevant functional activities, such as stair walking, slope walking, crouching, walking different path shapes. During this execution the Ratings of Perceived Exertion will be questioned, and simultaneously physiological and movement data will be collected.

Primary outcomes

  1. Changes in the Ratings of Perceived Exertion throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    The subjective feelings of fatigue will be evaluated through the Ratings of Perceived Exertion. This will be expressed verbally by the participant throughout the execution of the protocol.

Secondary outcomes

  1. Changes in muscle activity throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    Muscle activity data (EMG) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.

  2. Changes in heart rate (variability) throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    Cardiorespiratory data (Heart rate) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.

  3. Changes in oxygen saturation throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    Oxygen saturation data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.

  4. Changes in electrodermal activity throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    Electrodermal activity data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.

  5. Changes in muscle force myography throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    Muscle force myography data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.

  6. Changes in skin temperature throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    Skin temperature data (degrees Celsius) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.

  7. Changes in motion data throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    IMU data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.

  8. Changes in plantar pressure throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    Plantar pressure distribution data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.

  9. Changes in gaze patter throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    Eye tracking data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.

  10. Changes in joint angles throughout the protocol execution

    Time frame: Collected during all measurement moments (2-12 weeks).

    Kinematic data (degrees) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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