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NOT YET RECRUITING
NCT07891273
NA

Beyond Voluntary Effort: Reliability and Validity of Magnetic Femoral Nerve Stimulation for Assessing Quadriceps Strength in Critically Ill Patient

Sponsor: Daniel Langer

View on ClinicalTrials.gov

Summary

Intensive care unit-acquired weakness (ICU-AW) is a common complication of critical illness and can negatively affect recovery and long-term physical functioning. Early and reliable assessment of muscle strength is essential for detecting muscle weakness and monitoring changes during an intensive care unit (ICU) stay. However, conventional strength assessments, such as manual muscle testing, require voluntary muscle contractions, making them unsuitable for patients who are not yet cooperative and limiting the possibility of assessing muscle strength during the early stages of critical illness. Magnetic femoral nerve stimulation offers an alternative, non-volitional approach to assessing quadriceps muscle strength. Nevertheless, the reliability and validity of this technique in critically ill patients remain insufficiently established. This prospective methodological study aims to investigate the reliability and convergent validity of quadriceps twitch force measurements obtained using magnetic femoral nerve stimulation in critically ill patients. A total of 33 cooperative adult patients admitted to medical or surgical ICUs will be included. Participants will undergo repeated quadriceps twitch force assessments over two consecutive days, performed by two assessors. Measurements will be conducted using a custom-developed frame designed to facilitate standardized quadriceps strength assessment at the bedside. Both single and paired magnetic stimulation techniques will be evaluated. The primary outcome is the intra-rater reliability of paired twitch force measurements. Secondary outcomes include the inter-rater reliability of paired twitch force measurements, the intra-rater and inter-rater reliability of single twitch force measurements, and the convergent validity of twitch force measurements assessed through their association with maximal voluntary contraction force and potentiated twitch force. Reliability and agreement will be evaluated using intraclass correlation coefficients and complementary measurement error analyses. Establishing these measurement properties could support objective, non-volitional muscle strength assessment in critically ill patients, including those unable to participate in conventional strength testing. This could facilitate early baseline strength assessment, longitudinal monitoring of muscle recovery, and the evaluation of interventions aimed at preventing or treating ICU-AW..

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2026-12

Completion Date

2027-05

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Magnetic Femoral Nerve Stimulation

Participants will be positioned prone in their hospital bed, with the knee flexed at approximately 90° using a dedicated measurement setup. A magnetic stimulation coil will be placed over the femoral nerve to elicit involuntary quadriceps muscle contractions. The resulting twitch force will be measured using a strain gauge dynamometer attached at the ankle. Stimulation intensity will be progressively increased to establish supramaximal stimulation, after which both single and paired magnetic stimuli will be applied to assess quadriceps twitch force.