High-definition Surface Electromyography Markers for the Diagnosis of Sarcopenia
NCT ID: NCT04987814
Last Updated: 2025-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
175 participants
INTERVENTIONAL
2022-05-18
2026-12-18
Brief Summary
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In this pilot project, the investigators want to explore the potential of the high-definition surface electromyography technology (HD-sEMG) for the diagnosis of sarcopenia.
This is a monocentric, descriptive, cross-sectional, parallel group study to develop a new diagnostic method.
It is planned to include 50 people aged 75 years and over hospitalized in the acute geriatric ward and suspected of sarcopenia (Score ≥4 on the SARC-F screening questionnaire).
The inclusion duration will be 36 months and adding a 1-month patient follow-up as part of routine care, the total study duration will be 37 months.
Patients will have their body composition (muscle mass, fat mass, and bone mass) using dual X-ray absorptiometry (DEXA). Muscular strength will be assessed by handgrip strength. Physical performance will be assessed. Additional data will be collected from their medical records.
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Detailed Description
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Sarcopenia is defined as a progressive loss of muscle mass, strength and physical performance. Classically, sarcopenia is assessed by imaging techniques (MRI, DEXA) or bioelectrical impedancemetry for aspects related to the assessment of muscle mass loss. MRI or DEXA are not widely available and/or access is limited.
For functional aspects, grip strength measurements are often used. Currently sarcopenia cannot be diagnosed and evaluated by a single examination, including both the morphological (muscle mass) and functional aspects. Furthermore, several biological markers are associated with muscle mass, strength, and function, but these biomarkers are not specific to skeletal muscle and are weakly associated with clinical goals.
Finally, despite the important interest in assessing the qualitative/functional and quantitative aspect of skeletal muscle in neuromuscular impairment, there is currently no tool that routinely assesses these aspects.
In this context, developing new approaches for non-invasive assessment of sarcopenia, is a major issue. In this pilot project, the investigators aim to develop a medical device derived from high-definition surface electromyography (HD-sEMG) technology, non-invasive and portable, for the diagnosis of sarcopenia.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Elderly patients suspected of sarcopenia
HD-sEMG
high definition surface electromyography, allowing the recording of muscle activation signals sensitive to the intensity of the contraction and indirectly to the muscle strength as well as to the muscular fatigability, but also capable of measuring the modifications of the recruitment modalities of the motor units. This recording will be made on the rectus femoris during knee extension, either in the lying position or during chair lifts, depending on the patient's functional state.
- Quadriceps muscle ultrasound
Muscle Ultrasound with Philips Lumify Wireless Handheld Ultrasound for Android - Model - L12-4 linear probe, allowing performance at the patient's bed.
IPAQ Physical Activity Questionnaire.
physical activity assessment questionnaire/adapted version for seniors
Interventions
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HD-sEMG
high definition surface electromyography, allowing the recording of muscle activation signals sensitive to the intensity of the contraction and indirectly to the muscle strength as well as to the muscular fatigability, but also capable of measuring the modifications of the recruitment modalities of the motor units. This recording will be made on the rectus femoris during knee extension, either in the lying position or during chair lifts, depending on the patient's functional state.
- Quadriceps muscle ultrasound
Muscle Ultrasound with Philips Lumify Wireless Handheld Ultrasound for Android - Model - L12-4 linear probe, allowing performance at the patient's bed.
IPAQ Physical Activity Questionnaire.
physical activity assessment questionnaire/adapted version for seniors
Eligibility Criteria
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Inclusion Criteria
* Score ≥4 on the SARC-F screening questionnaire
* Enrolled in a social security plan (no AME)
* Informed and consenting patient
Exclusion Criteria
* Untreated/unbalanced endocrinological pathology
* Myopathy
* Inflammatory or autoimmune pathology
* Severe psychiatric pathology or severe cognitive disorders that do not allow the performance of examinations
* Patients who are dependent for all acts of daily life
* Patients with a very short life expectancy
* Recent fracture or trauma of the lower limbs preventing dynamic measurement of HD-sEMG recording
* Bilateral hip prosthesis
* Skin problem that may interfere with the recording of surface EMG activity
* Patient under guardianship / curatorship
75 Years
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Kiyoka KINUGAWA, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Service de gériatrie aigue polyvalente (GAP)
Ivry-sur-Seine, , France
Service de soins de suite et de réadaptation Gériatrique 1
Ivry-sur-Seine, , France
Service de soins de suite et de réadaptation gériatrique 2
Ivry-sur-Seine, , France
Unité d'Explorations fonctionnelles du sujet âgé, Hôpital Charles Foix
Ivry-sur-Seine, , France
Service de soins de suite et de réadaptation -Plaies et cicatrisation
Paris, , France
Service de soins de suite et de réadaptation Gériatrique Hôpital Rothschild
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP201339
Identifier Type: -
Identifier Source: org_study_id
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