Muscle WeaknessDYNAMIQUENCT04696497
Muscle Function and Muscle Ultrasound in ICU
A study testing Ultrasound, Dynamometric muscular assessment and Manual muscular Assessment (MRC-SS) in people with Muscle Weakness, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The objective of intensive care therapists is to be able to detect as early as possible the muscle weakness acquired in intensive care, in order to implement curative strategies such as adapted nutrition and early rehabilitation. Various diagnostic tools are available for this purpose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Ultrasound, Dynamometric muscular assessment and Manual muscular Assessment (MRC-SS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2021to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient > 18 years old
- Admission for more than 24 hours in the ICU ward
- Stay must be at least 72 hours
Who cannot join
- Person with a neuromuscular pathology
- Person presenting an osteoarticular contraindication to mobilization
- Amputee
- Person under guardianship or curatorship
- Person not affiliated to a social security system
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Muscle Function at Discharge From ICU: Evaluation of the Correlation Between Manual Muscle Testing, Dynamometric and Peripheral Ultrasound Parameters
The objective of intensive care therapists is to be able to detect as early as possible the muscle weakness acquired in intensive care, in order to implement curative strategies such as adapted nutrition and early rehabilitation. Various diagnostic tools are available for this purpose. To evaluate muscle mass, CT and MRI remain the gold standard but are difficult to implement in routine practice in ICU and are extremely expensive and can generate radiation for the patient.
Functional muscle evaluation is based on different voluntary tests which are not all able to predict muscle weakness acquired in ICU. In addition, some of the voluntary tests are expensive and require expert staff for practice and interpretation of results.
Read more
In addition, a muscle test such as MRC, although having an intraclass coefficient of 0.94, has little predictive value on clinical parameters such as mechanical ventilation duration and is not associated with mortality in the ward. However, it remains the test of choice to define a ICUAW with a threshold value of 48/60 points.
Dynamometry is a tool for measuring muscle strength. The patient is asked to perform a short and intense maximal muscular effort against manual or instrumental resistance. The limb segments must not move, it is an isometric effort. The most common measurement in intensive care units is the dynamometric grip force, called "handgrip".
In ICU, the patient may have touble with awareness, arousal or even comprehension, which will lead to biases in the evaluation of the motor force.
Ultrasound is a tool available in ICU and the muscle component can be assessed qualitatively or quantitatively without the patient's participation. Several studies have also demonstrated that muscle ultrasound is capable of reliably detecting pathological changes, particularly when repeated. Muscle ultrasound could thus help identify patients at higher risk of prolonged complications. Nevertheless, this technique lacks standardization and normative criteria (patient position, probe position, type and number of measurements, target muscle, etc.).
The main objective is to show that the dynamometric force relative to ultrasound thickness of several muscle groups (arm flexors/knee extensors/foot lifters) is correlated with manual MRC testing in intensive care unit (ICU) patients
Read the detailed description
When the patient will be under invasive ventilatory support and coma, and will present the inclusion criteria, the investigator will perform ultrasound measurements of muscle thickness on four muscle groups:
- Shoulder Side muscular compartment
- Anterior Arm muscular compartment
- Anterior thigh muscular compartment
- Antero-lateral leg muscular compartment The ultrasound measurements will be made once a day each weekday, until the discharge from ICU.
Ultrasound measurements will be stopped if the patient's condition deteriorates and the ICU team chooses to limit active therapy.
If the patient condition get better, the investigator will perform the first volitional muscle function assessment, as soon as the patient Glasgow scale will score 15/15:
- Medical Research Council sum score (MRC-ss)
- Dynamometric strength assessment with the muscular groups used for the MRC-ss Then the volitional muscle assessment will be made once every 3 days, until patient discharges from ICU.
- Conditions
- Muscle Weakness
- Being tested
- Ultrasound, Dynamometric muscular assessment, Manual muscular Assessment (MRC-SS)
- Keywords
- Intensive care unit, Dynamometric, Ultrasound, Medical Research Council sum score, Ultrasonography, Muscle Strength, Critical Care
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Ultrasound measurements of muscle thickness, using a linear probe (high frequency) on four muscle groups:
- Shoulder Side muscular compartment
- Anterior Arm muscular compartment
- Anterior thigh muscular compartment
- Antero-lateral leg muscular compartment
Dynamometric muscular assessmentDiagnostic test
The principle of electronic dynamometry is to measure an isometric force. To carry out these measurements, the examiner will stand on the side who has to be tested by exerting a pressure diametrically opposite to the patient's movement, thus preventing him/her from carrying out the movement. The patient will perform 3 tests for each movement, the best value will be collected by the examiner.
The reference position is :
Patient elbowed to the body bent at 90°, with trunk inclination at 30° in the resuscitation bed, lower limbs flat.
Manual muscular Assessment (MRC-SS)Diagnostic test
Following the same positions as for the dynamometer, the examiner will evaluate the 12 motor functions according to the following 60-point rating. With the maximum quote of 5 point representing normal strength and 0 point the total absence of any muscular contraction
| Study group | Role | What they receive |
|---|---|---|
| Muscular Assessment | Other | All the patients will received the muscular assessments Receives: Diagnostic Test: Ultrasound; Diagnostic Test: Dynamometric muscular assessment; Diagnostic Test: Manual muscular Assessment (MRC-SS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between force/thickness ratio and MRC testing.
To show that the dynamometric force relative to ultrasound thickness of several muscle groups (arm flexors/knee extensors/foot lifters) is correlated with manual MRC testing in intensive care medicine patients
Measured: Day 28
Secondary outcomes (3)
Modification in millimeters of ultrasound muscle thickness
Modification in millimeters of ultrasound muscle thickness
Measured: Day 28
Change in force measured by dynamometry in patients with more than 2 evaluations
Change in force measured by dynamometry in patients with more than 2 evaluations
Measured: Day 28
Medical Research Council sum-score (MRC-ss)
Following the same positions as for the dynamometer evaluation, the examiner will evaluate the 12 motor functions according to the following 60-point rating. With the maximum quote of 5 point representing normal strength and 0 point the total absence of any muscular contraction.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start17 Dec 2021
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Why it stopped: inclusion difficulties and reorganization of the principal investigator's activity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume FOSSAT, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696497
- Sponsor's protocol ID
- CHRO-2020-02
- Acronym
- DYNAMIQUE
- Status last verified
- Apr 2025
- First submitted
- 4 Dec 2020
- Last updated
- 20 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
PubMed 24758618Hermans G, Van den Berghe G. Clinical review: intensive care unit acquired weakness. Crit Care. 2015 Aug 5;19(1):274. doi: 10.1186/s13054-015-0993-7.
PubMed 26242743Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. doi: 10.1164/rccm.200505-693OC. Epub 2006 Jun 8.
PubMed 16763220Cuthbertson BH, Roughton S, Jenkinson D, Maclennan G, Vale L. Quality of life in the five years after intensive care: a cohort study. Crit Care. 2010;14(1):R6. doi: 10.1186/cc8848. Epub 2010 Jan 20.
PubMed 20089197Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
PubMed 12594312
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Muscle Function at Discharge From ICU: Evaluation of the Correlation Between Manual Muscle Testing, Dynamometric and Peripheral Ultrasound Parameters
- ClinicalTrials.gov ID
- NCT04696497
- Acronym / sponsor ID
- DYNAMIQUE / CHRO-2020-02
- Conditions
- Muscle Weakness
- Keywords
- Intensive care unit, Dynamometric, Ultrasound, Medical Research Council sum score, Ultrasonography, Muscle Strength, Critical Care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion difficulties and reorganization of the principal investigator's activity
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of intensive care therapists is to be able to detect as early as possible the muscle weakness acquired in intensive care, in order to implement curative strategies such as adapted nutrition and early rehabilitation. Various diagnostic tools are available for this purpose. To evaluate muscle mass, CT and MRI remain the gold standard but are difficult to implement in routine practice in ICU and are extremely expensive and can generate radiation for the patient.
Functional muscle evaluation is based on different voluntary tests which are not all able to predict muscle weakness acquired in ICU. In addition, some of the voluntary tests are expensive and require expert staff for practice and interpretation of results.
In addition, a muscle test such as MRC, although having an intraclass coefficient of 0.94, has little predictive value on clinical parameters such as mechanical ventilation duration and is not associated with mortality in the ward. However, it remains the test of choice to define a ICUAW with a threshold value of 48/60 points.
Dynamometry is a tool for measuring muscle strength. The patient is asked to perform a short and intense maximal muscular effort against manual or instrumental resistance. The limb segments must not move, it is an isometric effort. The most common measurement in intensive care units is the dynamometric grip force, called "handgrip".
In ICU, the patient may have touble with awareness, arousal or even comprehension, which will lead to biases in the evaluation of the motor force.
Ultrasound is a tool available in ICU and the muscle component can be assessed qualitatively or quantitatively without the patient's participation. Several studies have also demonstrated that muscle ultrasound is capable of reliably detecting pathological changes, particularly when repeated. Muscle ultrasound could thus help identify patients at higher risk of prolonged complications. Nevertheless, this technique lacks standardization and normative criteria (patient position, probe position, type and number of measurements, target muscle, etc.).
The main objective is to show that the dynamometric force relative to ultrasound thickness of several muscle groups (arm flexors/knee extensors/foot lifters) is correlated with manual MRC testing in intensive care unit (ICU) patients
Detailed description
When the patient will be under invasive ventilatory support and coma, and will present the inclusion criteria, the investigator will perform ultrasound measurements of muscle thickness on four muscle groups:
- Shoulder Side muscular compartment
- Anterior Arm muscular compartment
- Anterior thigh muscular compartment
- Antero-lateral leg muscular compartment The ultrasound measurements will be made once a day each weekday, until the discharge from ICU.
Ultrasound measurements will be stopped if the patient's condition deteriorates and the ICU team chooses to limit active therapy.
If the patient condition get better, the investigator will perform the first volitional muscle function assessment, as soon as the patient Glasgow scale will score 15/15:
- Medical Research Council sum score (MRC-ss)
- Dynamometric strength assessment with the muscular groups used for the MRC-ss Then the volitional muscle assessment will be made once every 3 days, until patient discharges from ICU.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscular Assessment | Other | Diagnostic Test: Ultrasound, Diagnostic Test: Dynamometric muscular assessment, Diagnostic Test: Manual muscular Assessment (MRC-SS)All the patients will received the muscular assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major patient > 18 years old
- Admission for more than 24 hours in the ICU ward
- Stay must be at least 72 hours
Key exclusion criteria (6 listed)
- Person with a neuromuscular pathology
- Person presenting an osteoarticular contraindication to mobilization
- Amputee
- Person under guardianship or curatorship
- Person not affiliated to a social security system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound measurements of muscle thickness, using a linear probe (high frequency) on four muscle groups: * Shoulder Side muscular compartment * Anterior Arm muscular compartment * Anterior thigh muscular compartment * Antero-lateral leg muscular compartment | Diagnostic test | Muscular Assessment |
| Dynamometric muscular assessmentThe principle of electronic dynamometry is to measure an isometric force. To carry out these measurements, the examiner will stand on the side who has to be tested by exerting a pressure diametrically opposite to the patient's movement, thus preventing him/her from carrying out the movement. The patient will perform 3 tests for each movement, the best value will be collected by the examiner. The reference position is : Patient elbowed to the body bent at 90°, with trunk inclination at 30° in the resuscitation bed, lower limbs flat. | Diagnostic test | Muscular Assessment |
| Manual muscular Assessment (MRC-SS)Following the same positions as for the dynamometer, the examiner will evaluate the 12 motor functions according to the following 60-point rating. With the maximum quote of 5 point representing normal strength and 0 point the total absence of any muscular contraction | Diagnostic test | Muscular Assessment |
Primary outcome
Correlation coefficient between force/thickness ratio and MRC testing.
Time frame: Day 28
To show that the dynamometric force relative to ultrasound thickness of several muscle groups (arm flexors/knee extensors/foot lifters) is correlated with manual MRC testing in intensive care medicine patients
3 secondary outcomes
Modification in millimeters of ultrasound muscle thickness
Time frame: Day 28
Change in force measured by dynamometry in patients with more than 2 evaluations
Time frame: Day 28
Medical Research Council sum-score (MRC-ss)
Time frame: Day 28
Results and safety
The study was stopped early (reason given: inclusion difficulties and reorganization of the principal investigator's activity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Background: PubMed 24758618Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
- Background: PubMed 26242743Hermans G, Van den Berghe G. Clinical review: intensive care unit acquired weakness. Crit Care. 2015 Aug 5;19(1):274. doi: 10.1186/s13054-015-0993-7.
- Background: PubMed 16763220Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. doi: 10.1164/rccm.200505-693OC. Epub 2006 Jun 8.
- Background: PubMed 20089197Cuthbertson BH, Roughton S, Jenkinson D, Maclennan G, Vale L. Quality of life in the five years after intensive care: a cohort study. Crit Care. 2010;14(1):R6. doi: 10.1186/cc8848. Epub 2010 Jan 20.
- Background: PubMed 12594312Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume FOSSAT principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound, Dynamometric muscular assessment and Manual muscular Assessment (MRC-SS) in people with Muscle Weakness, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inclusion difficulties and reorganization of the principal investigator's activity). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between force/thickness ratio and MRC testing. (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696497, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.