NCT07465328

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Feb 2025Feb 2027

Study Start

First participant enrolled

February 11, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2027

Expected
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

March 6, 2026

Last Update Submit

March 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (1)

  • Measuring muscle oxygenation

    2 years

Study Arms (1)

Measuring MVC's of participants

EXPERIMENTAL
Other: MVC measurements of participants

Interventions

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.

Measuring MVC's of participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

Location

MeSH Terms

Conditions

SarcopeniaStroke

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 11, 2026

Study Start

February 11, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

February 11, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations