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Evaluating and Monitoring Physical Fatigue While Performing Functional Activities

Evaluating and Monitoring Physical Fatigue While Performing Functional Activities

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06513377
Enrollment
40
Registered
2024-07-22
Start date
2025-03-20
Completion date
2025-10-15
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Sarcopenia, Stroke

Brief summary

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.

Interventions

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.

Sponsors

Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the Ratings of Perceived Exertion throughout the protocol executionCollected 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

MeasureTime frameDescription
Changes in muscle activity throughout the protocol executionCollected 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.
Changes in heart rate (variability) throughout the protocol executionCollected 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.
Changes in oxygen saturation throughout the protocol executionCollected 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.
Changes in electrodermal activity throughout the protocol executionCollected 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.
Changes in muscle force myography throughout the protocol executionCollected 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.
Changes in skin temperature throughout the protocol executionCollected 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.
Changes in motion data throughout the protocol executionCollected 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.
Changes in plantar pressure throughout the protocol executionCollected 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.
Changes in gaze patter throughout the protocol executionCollected 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.
Changes in joint angles throughout the protocol executionCollected 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026