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CompletedNCT06746493Updated Dec 27, 2024

The Assessment of Knee Joints Function in People After Stroke

An observational study in Stroke, sponsored by Poznan University of Medical Sciences. Completed at 1 site in Poland. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Poznan University of Medical Sciences · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
35 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • function of knee joint
  • physiotherapy
  • wireless sensors
  • functional tests
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 50 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Poznan University of Medical Sciences is the lead sponsor of 143 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
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.

Eligibility criteria

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.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Rehabilitation

  • Control group

    The control group consisted of healthy subjects.

Interventions

  • OtherRehabilitation

    People after a stroke participated in a standard rehabilitation process carried out at the neurological rehabilitation department.

    Also known as: Physical rehabilitation

06

What researchers measure

Primary outcomes

  1. Assessment of the passive and active range of motion of the knee joint using wireless motion sensors connected to a mobile application.

    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.

    Time frame: Baseline and after about 15 days of exercise.

  2. Proprioception

    Assessment of joint position sensation (3 different positions indicated) in degrees using wireless sensors.

    Time frame: Baseline and after about 15 days of exercise.

  3. Assessment of the active range of motion of the knee and hip joint during functional tasks

    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.

    Time frame: Baseline and after about 15 days of exercise.

  4. Assessment of the maximum angle of varus and valgus at the knee joint during functional tasks

    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.

    Time frame: Baseline and after about 15 days of exercise.

  5. Assessment of the mean squared error at the knee joint during functional tasks

    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.

    Time frame: Baseline and after about 15 days of exercise.

  6. Assessment of the speed of movement in the knee joint during functional tasks

    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.

    Time frame: Baseline and after about 15 days of exercise.

  7. Step test

    Assessment of the number of repetitions.

    Time frame: Baseline and after about 15 days of exercise.

  8. The Five Times Sit-to-Stand Test

    Assessment of task completion time.

    Time frame: Baseline and after about 15 days of exercise.

  9. Timed Up&Go Test

    Assessment of task completion time.

    Time frame: Baseline and after about 15 days of exercise.

  10. 30-s Chair Stand Test

    Assessment of the number of repetitions.

    Time frame: Baseline and after about 15 days of exercise.

  11. 5m walking test

    Assessment of task completion time.

    Time frame: Baseline and after about 15 days of exercise.

  12. Assessment of isometric muscle strength of knee flexors and extensors using Leg Force Feedback device.

    Measurement of the maximal voluntary isometric contraction torque of the knee extensor and flexor muscle groups in Newton-meter.

    Time frame: Baseline and after about 15 days of exercise.

  13. Symmetry

    Assessment of the load on the lower limbs while standing in percentage.

    Time frame: Baseline and after about 15 days of exercise.

Secondary outcomes

  1. Assessment of the center of pressure path length when measuring on a balance platform

    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.

    Time frame: Baseline and after about 15 days of exercise.

  2. Assessment of the center of pressure velocity when measuring on a balance platform

    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.

    Time frame: Baseline and after about 15 days of exercise.

  3. Balance

    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.

    Time frame: Baseline and after about 15 days of exercise.

07

Study locations

1 site
  • Poznan University of Medical Sciences
    Poznań, 61-701, Poland
08

References and documents

Individual participant data

Plan to share: No — The data is available in the form of an anonymized CSV sheet.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06746493
Lead sponsor
Poznan University of Medical Sciences
Responsible party
Agnieszka Wareńczak-Pawlicka (Study Chair: Agnieszka Wareńczak-Pawlicka, PhD, Department of Rehabilitation and Physiotherapy Rehabilitation, Poznan University of Medical Sciences) — Principal investigator
First posted
Dec 24, 2024
Start date
Nov 10, 2021
Primary completion
Apr 7, 2022
Completion
Jun 15, 2022
Last update
Dec 27, 2024

Study contacts

Agnieszka Wareńczak-Pawlicka, PhD
principal investigator · Poznan University of Medical Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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