SarcopeniaNCT07465328
Studying the Impairment of Stroke and Sarcopenia Patients Using Maximum Voluntary Contractions of the Leg Joints.
A study testing MVC measurements of participants in people with Sarcopenia and Stroke, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The goal of this study is to obtain the maximum voluntary torques of the lower-limb joints and to monitor oxygen level in the main lower-limb muscles. This will be done for three joints: i.e. the hip, knee and ankle joint and NIRS sensors will be placed on the biceps femoris, rectus femoris and gastrocnemius muscle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Stroke
- What is being tested?
- MVC measurements of participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Feb 2025to 11 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Post stroke patients:
- Must be 18+ years old
- Must be three months or more after stroke diagnosis
- Have difficulties with gait (FAC level 3-4)
Sarcopenia patients:
- Must be 65+ years old
- Not be able to perform five chair sit to stands within 15 seconds
- Grip strength of less than 27 kg for men and less than 16 kg for females
- Have difficulties with gait (SPPB ≤ 8)
Healthy participants:
- No physical injuries that limits the torque production in lower-limb joints
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studying the Impairment of Stroke and Sarcopenia Pa-tients Using Maximum Voluntary Contractions of the Leg Joints.
The goal of this study is to obtain the maximum voluntary torques of the lower-limb joints and to monitor oxygen level in the main lower-limb muscles. This will be done for three joints: i.e. the hip, knee and ankle joint and NIRS sensors will be placed on the biceps femoris, rectus femoris and gastrocnemius muscle. For the hip and knee, the maximum torque will be determined both in exertion direction and flexion direction. For the ankle, both plantarflexion and dorsiflexion will be considered. For each of these directions, the maximum joint torque will be defined for different specific joint angles and joint velocities (see procedure). For every joint and for the whole protocol for the torques measurement campaign, the different muscle of interest will be monitored with the NIRS, i.e. hip is associated with hamstring contraction, knee is associated with thigh contraction and ankle is associated with calf contraction. With these discrete points, an algorithm will be used to obtain a complete plot of the maximum torque in function of both joint angle and joint velocities. Comparing these plots between for example stroke and healthy individuals can help us understand what level of assistance stroke patients require. Comparison in oxygen level between healthy individuals and impairments population of stroke and sarcopenia patients can also help us investigate how oxygen is used depending on the population.
- Conditions
- Sarcopenia, Stroke
- Being tested
- MVC measurements of participants
- Medical subject headings
- Sarcopenia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVC measurements of participantsOther
The protocol will be performed for six exertion directions for both legs: Hip Extension (HE), Hip Flexion (HF), Knee Extension (KE), Knee Flexion (KF), Plantar Flexion (PF) and Dorsi Flexion (DF). The protocol will be similar for each of these directions. The protocol described below will be performed for each joint. Position of subject during testing:
- Ankle: hip flexed at 80° and knee flexed at 50° (in a seated position)
- Knee: hip flexed at 70° (in a seated position)
- Hip: done in a standing position. The knee slightly flexed with a knee immobilizer.
| Study group | Role | What they receive |
|---|---|---|
| Measuring MVC's of participants | Experimental | Not described Receives: Other: MVC measurements of participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining maximum voluntary torques of the lower-limb joints for sarcopenia and stroke patients
The goal is to determine the maximum torque that each joint can produce in an isostatic case in the sagittal plane. Not only the amount of torque but also at which joint angle this manifests are important parameters that we would like to use for the design process of an exoskeleton. Furthermore, we'd like to obtain the change in maximum torque when transferring from an isostatic test to an isokinetic test. The higher the joint velocity, the more the torque will decrease. However, how much is this decrease? We expect that the decrease for increased joint velocities in the targeted populations will differ compared to healthy individuals
Measured: 2 years
Secondary outcomes (1)
Measuring muscle oxygenation
To determine the differences in oxygen delivery and consumption between healthy individuals, sarcopenia patients, and stroke patients. Studying these profiles will provide insights into how these impairments affect the muscle under investigation and how oxygenation dynamics behave throughout the experiment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start11 Feb 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion11 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465328
- Sponsor's protocol ID
- BUN 1432024000256
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Impairment of Stroke and Sarcopenia Pa-tients Using Maximum Voluntary Contractions of the Leg Joints.
- ClinicalTrials.gov ID
- NCT07465328
- Acronym / sponsor ID
- BUN 1432024000256
- Conditions
- Sarcopenia, Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 11 Feb 2027 (estimated)
- First posted
- 11 Mar 2026 (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 goal of this study is to obtain the maximum voluntary torques of the lower-limb joints and to monitor oxygen level in the main lower-limb muscles. This will be done for three joints: i.e. the hip, knee and ankle joint and NIRS sensors will be placed on the biceps femoris, rectus femoris and gastrocnemius muscle. For the hip and knee, the maximum torque will be determined both in exertion direction and flexion direction. For the ankle, both plantarflexion and dorsiflexion will be considered. For each of these directions, the maximum joint torque will be defined for different specific joint angles and joint velocities (see procedure). For every joint and for the whole protocol for the torques measurement campaign, the different muscle of interest will be monitored with the NIRS, i.e. hip is associated with hamstring contraction, knee is associated with thigh contraction and ankle is associated with calf contraction. With these discrete points, an algorithm will be used to obtain a complete plot of the maximum torque in function of both joint angle and joint velocities. Comparing these plots between for example stroke and healthy individuals can help us understand what level of assistance stroke patients require. Comparison in oxygen level between healthy individuals and impairments population of stroke and sarcopenia patients can also help us investigate how oxygen is used depending on the population.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measuring MVC's of participants | Experimental | Other: MVC measurements of participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MVC measurements of participantsThe protocol will be performed for six exertion directions for both legs: Hip Extension (HE), Hip Flexion (HF), Knee Extension (KE), Knee Flexion (KF), Plantar Flexion (PF) and Dorsi Flexion (DF). The protocol will be similar for each of these directions. The protocol described below will be performed for each joint. Position of subject during testing: * Ankle: hip flexed at 80° and knee flexed at 50° (in a seated position) * Knee: hip flexed at 70° (in a seated position) * Hip: done in a standing position. The knee slightly flexed with a knee immobilizer. | Other | Measuring MVC's of participants |
Primary outcome
Obtaining maximum voluntary torques of the lower-limb joints for sarcopenia and stroke patients
Time frame: 2 years
The goal is to determine the maximum torque that each joint can produce in an isostatic case in the sagittal plane. Not only the amount of torque but also at which joint angle this manifests are important parameters that we would like to use for the design process of an exoskeleton. Furthermore, we'd like to obtain the change in maximum torque when transferring from an isostatic test to an isokinetic test. The higher the joint velocity, the more the torque will decrease. However, how much is this decrease? We expect that the decrease for increased joint velocities in the targeted populations will differ compared to healthy individuals
1 secondary outcome
Measuring muscle oxygenation
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MVC measurements of participants in people with Sarcopenia and Stroke, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Obtaining maximum voluntary torques of the lower-limb joints for sarcopenia and stroke patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.