The Assessment of Knee Joints Function in People After Stroke

NCT ID: NCT06746493

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2022-06-15

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.

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.

Conditions

Stroke

Keywords

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Rehabilitation

Intervention Type: OTHER

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

Control group

The control group consisted of healthy subjects.

No interventions assigned to this group

Interventions

Rehabilitation

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

Intervention Type: OTHER

Other Intervention Names

Physical rehabilitation

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Agnieszka Wareńczak-Pawlicka

Study Chair: Agnieszka Wareńczak-Pawlicka, PhD, Department of Rehabilitation and Physiotherapy Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Agnieszka Wareńczak-Pawlicka, PhD

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Medical Sciences

Locations

Poznan University of Medical Sciences

Poznan, , Poland

Countries

Poland

Other Identifiers

822/21

Identifier Type: -

Identifier Source: org_study_id