The Assessment of Knee Joints Function in People After Stroke

NCT06746493 | Completed

• 1 other identifier: 822/21
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

function of knee joint; physiotherapy; wireless sensors; functional tests

Outcome Measures

Primary Outcomes (13)

• 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.

  Baseline and after about 15 days of exercise.

• Proprioception

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

  Baseline and after about 15 days of exercise.

• 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.

  Baseline and after about 15 days of exercise.

• 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.

  Baseline and after about 15 days of exercise.

• 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.

  Baseline and after about 15 days of exercise.

• 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.

  Baseline and after about 15 days of exercise.

• Step test

  Assessment of the number of repetitions.

  Baseline and after about 15 days of exercise.

• The Five Times Sit-to-Stand Test

  Assessment of task completion time.

  Baseline and after about 15 days of exercise.

• Timed Up&Go Test

  Assessment of task completion time.

  Baseline and after about 15 days of exercise.

• 30-s Chair Stand Test

  Assessment of the number of repetitions.

  Baseline and after about 15 days of exercise.

• 5m walking test

  Assessment of task completion time.

  Baseline and after about 15 days of exercise.

• 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.

  Baseline and after about 15 days of exercise.

• Symmetry

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

  Baseline and after about 15 days of exercise.

Secondary Outcomes (3)

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

  Baseline and after about 15 days of exercise.

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

  Baseline and after about 15 days of exercise.

• Balance

  Baseline and after about 15 days of exercise.

Study Arms (2)

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

Rehabilitation OTHER

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

Also known as: Physical rehabilitation

Stroke group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study group comprised patients after stroke. The control group consisted of healthy volunteers.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 61-701, Poland

Location

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Agnieszka Wareńczak-Pawlicka, PhD

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair: Agnieszka Wareńczak-Pawlicka, PhD, Department of Rehabilitation and Physiotherapy Rehabilitation

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: December 24, 2024
• Study Start: November 10, 2021
• Primary Completion: April 7, 2022
• Study Completion: June 15, 2022
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)