- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465328
Studying the Impairment of Stroke and Sarcopenia Patients Using Maximum Voluntary Contractions of the Leg Joints.
Studying the Impairment of Stroke and Sarcopenia Pa-tients Using Maximum Voluntary Contractions of the Leg Joints.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1050
- Vrije Universiteit Brussel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Measuring MVC's 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:
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stroke
- Sarcopenia
Other Study ID Numbers
- BUN 1432024000256
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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