Studying the Impairment of Stroke and Sarcopenia Patients Using Maximum Voluntary Contractions of the Leg Joints.

March 6, 2026 updated by: Vrije Universiteit Brussel

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1050
        • Vrije Universiteit Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Measuring MVC's of participants
Other: MVC measurements of participants

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measuring muscle oxygenation
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vrije Universiteit Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BUN 1432024000256

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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