- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06746493
The Assessment of Knee Joints Function in People After Stroke
December 23, 2024 updated by: Agnieszka Wareńczak-Pawlicka, Poznan University of Medical Sciences
Is it Important to Assess the Function of the Knee Joint After a Stroke
The study aims to assess the function of knee joints in patients after stroke compared to healthy people and evaluate the impact of rehabilitation on the function of knee joints in people after stroke.
Study Overview
Detailed Description
Stroke patients were examined twice at the beginning of rehabilitation and after approximately 15 days of exercise.
The control group (healthy participants) was assessed once.
Wireless motion sensors connected to a mobile application were used to assess the kinematics of the knee joints.
They were used to assess the range of motion in the knee joints (passive, active, active at maximum speed), proprioception (joint position sense tests), step-up test, step-down test, getting up and sitting on a chair, step and squat.
Functional tests such as The Five Times Sit-to-Stand Test, Timed Up&Go, The Step Test, the 5m walking test, and the 30-s Chair Stand Test were carried out.
The strength of the knee extensors and flexors was also assessed using the Leg Force Feedback device.
Balance was assessed on a posturography platform by performing tests such as standing with eyes open and closed on a stable surface and standing with eyes open and closed on an unstable surface.
The symmetry of lower limb loads in a standing position was also assessed.
Study Type
Observational
Enrollment (Actual)
50
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
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Poznań, Poland, 61-701
- Poznan University of Medical Sciences
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study group comprised patients after stroke.
The control group consisted of healthy volunteers.
Description
Inclusion criteria to the stroke group were as follows :
- the time from stroke: less than a year,
- age: between 35 and 65 years old,
- ability to stand independently for at least 5 minutes without an assistive device,
- ability to walk 5 m independently,
- ability to communicate and understand the tasks required in the study,
- a modified Ashworth scale spasticity score of 1+ or less in the affected knee (0: no resistance, 5: affected parts stiff in flexion or extension),
- muscle strength on the Manual Muscle Test of 3/4 or more in the affected knee,
- Barthel Index score 80 or more.
Exclusion criteria from the post-stroke group were as follows:
- age below 35 or over 65,
- sensorimotor aphasia,
- cognitive disorders that make it impossible to understand and obey commands,
- lack of active movement in the knee joint,
- Manual Muscle Test strength of the quadriceps muscles below 3,
- no ability to walk 5 meters,
- lack of informed consent to participate in the study,
- other neurological diseases (such as MS, Parkinson's disease, neuropathies),
- fractures in the lower limbs, which could affect the structure and function of the knee joint,
- previous operations on the lower limbs (including ACL reconstruction, knee arthroplasty or hip, osteotomy of the knee joint).
- vision disorders,
- unilateral spatial neglect syndrome.
The control group consisted of healthy volunteers with no prior history of trauma or neurological disease affecting the structure and function of the lower limb.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Stroke group
All patients from the stroke group were examined twice at the beginning and the end of this trial by a physical therapist.
Patients participated in a rehabilitation program at the Neurological Rehabilitation Department between measurements.
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People after a stroke participated in a standard rehabilitation process carried out at the neurological rehabilitation department.
Other Names:
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Control group
The control group consisted of healthy subjects.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of the passive and active range of motion of the knee joint using wireless motion sensors connected to a mobile application.
Time Frame: Baseline and after about 15 days of exercise.
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Measurement of the passive and active range of motion of the knee joint in degrees in lying position using wireless motion sensors connected to a mobile application.
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Baseline and after about 15 days of exercise.
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Proprioception
Time Frame: Baseline and after about 15 days of exercise.
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Assessment of joint position sensation (3 different positions indicated) in degrees using wireless sensors.
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Baseline and after about 15 days of exercise.
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Assessment of the active range of motion of the knee and hip joint during functional tasks
Time Frame: Baseline and after about 15 days of exercise.
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Measurement of the range of motion of the knee and hip joint using wireless motion sensors connected to a mobile application during functional tasks such as: step up, step down, squat, sitting on a chair and getting up from a chair and step forward.
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Baseline and after about 15 days of exercise.
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Assessment of the maximum angle of varus and valgus at the knee joint during functional tasks
Time Frame: Baseline and after about 15 days of exercise.
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Measurement of the maximum angle of varus and valgus at the knee joint using wireless motion sensors connected to a mobile application during functional tasks such as: step up, step down, squat, sitting on a chair and getting up from a chair and step forward.
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Baseline and after about 15 days of exercise.
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Assessment of the mean squared error at the knee joint during functional tasks
Time Frame: Baseline and after about 15 days of exercise.
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Measurement of the mean squared error using wireless motion sensors connected to a mobile application during active flexion and extension motion in the knee joint at maximum speed and functional tasks such as: step up, step down, squat, sitting on a chair and getting up from a chair and step forward.
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Baseline and after about 15 days of exercise.
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Assessment of the speed of movement in the knee joint during functional tasks
Time Frame: Baseline and after about 15 days of exercise.
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Measurement of the speed of movement in the knee joint during active flexion and extension motion in the knee joint at maximum speed and functional tasks such as: squat and sitting on a chair and getting up from a chair.
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Baseline and after about 15 days of exercise.
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Step test
Time Frame: Baseline and after about 15 days of exercise.
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Assessment of the number of repetitions.
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Baseline and after about 15 days of exercise.
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The Five Times Sit-to-Stand Test
Time Frame: Baseline and after about 15 days of exercise.
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Assessment of task completion time.
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Baseline and after about 15 days of exercise.
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Timed Up&Go Test
Time Frame: Baseline and after about 15 days of exercise.
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Assessment of task completion time.
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Baseline and after about 15 days of exercise.
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30-s Chair Stand Test
Time Frame: Baseline and after about 15 days of exercise.
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Assessment of the number of repetitions.
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Baseline and after about 15 days of exercise.
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5m walking test
Time Frame: Baseline and after about 15 days of exercise.
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Assessment of task completion time.
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Baseline and after about 15 days of exercise.
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Assessment of isometric muscle strength of knee flexors and extensors using Leg Force Feedback device.
Time Frame: Baseline and after about 15 days of exercise.
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Measurement of the maximal voluntary isometric contraction torque of the knee extensor and flexor muscle groups in Newton-meter.
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Baseline and after about 15 days of exercise.
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Symmetry
Time Frame: Baseline and after about 15 days of exercise.
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Assessment of the load on the lower limbs while standing in percentage.
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Baseline and after about 15 days of exercise.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of the center of pressure path length when measuring on a balance platform
Time Frame: Baseline and after about 15 days of exercise.
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Measurement of parameter such as total path length (cm).
A test was performed in four conditions: standing with eyes open and closed on a stable surface and standing with eyes open and closed on an unstable surface.
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Baseline and after about 15 days of exercise.
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Assessment of the center of pressure velocity when measuring on a balance platform
Time Frame: Baseline and after about 15 days of exercise.
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Assessment of parameter such as average speed (cm/s).
A test was performed in four conditions: standing with eyes open and closed on a stable surface and standing with eyes open and closed on an unstable surface.
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Baseline and after about 15 days of exercise.
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Balance
Time Frame: Baseline and after about 15 days of exercise.
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The test was performed in four conditions: standing with eyes open and closed on a stable surface and standing with eyes open and closed on an unstable surface.
The results were obtained in percentage values and compared to the normative results from the system.
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Baseline and after about 15 days of exercise.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Agnieszka Wareńczak-Pawlicka, PhD, Poznan University of Medical Sciences
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)
November 10, 2021
Primary Completion (Actual)
April 7, 2022
Study Completion (Actual)
June 15, 2022
Study Registration Dates
First Submitted
March 11, 2024
First Submitted That Met QC Criteria
December 20, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 23, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 822/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data is available in the form of an anonymized CSV sheet.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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