Core Stability Via Telerehabitation on TKA

Telerehabilitation Clinical Trial

Official title:

Investigation of the Effects of Core Stability Exercises Added to the Standard Exercise Program on Patient-Reported and Performance-Based Outcomes in Total Knee Arthroplasty Patients Followed With Telerehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06159205
• Other study ID #: ErsoyU.E-60116787-020-90137
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 17, 2023

Study information

• Verified date: December 2023
• Source: Burdur Mehmet Akif Ersoy University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To investigate the effects of core stability exercises (CSE) added to the standard exercises (SE) on patient-reported (PR) and performance-based (PB) outcomes in patients with total knee arthroplasty (TKA) followed with telerehabilitation (TR). Methods: The 42 patients who participated in the study were randomly divided into 2 groups [group 1: SE (n= 21), group 2: SE + CSE (n= 21)]. The first 8 weeks of the post-discharge follow-up were performed by videoconference-based TR under the supervision of a physiotherapist and the last 4 weeks by telephone-based TR. Functional level was assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pain intensity by Visual Analog Scale (VAS), affected knee range of motion (ROM) by Copenhagen Knee Range of Motion Scale (CKRS), quality of life by Short Form-12 (SF-12) and World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF), lower extremity muscle strength by 30-seconds Chair-Stand Test and locomotor performance by Stair Climb Test. Assessments were performed with TR preoperatively and at the first, second and third post-op months.

Description:

At the beginning of the study, an exercise booklet and exercise videos were prepared to be followed throughout the follow-up period. Subsequently, a telerehabilitation (TR) system was established using a laptop computer, a smartphone and a camera as hardware and WhatsApp® and Zoom® applications as software. The surgeries of all patients participating in the study were performed by the same surgical team with fast-track surgical procedure. Until discharge (1 day), a standard physiotherapy and rehabilitation (PTR) program consisting of range of motion and strengthening exercises, cold application, weight transfer and walking training was applied to both groups of patients. At the time of discharge, each patient was given an exercise booklet according to the intervention group. During the follow-up period, only the interventions included in the standard exercise (SE) program were applied to the SE group, while interventions included in both the SE and core stability exercise (CSE) program were applied to the SE + CSE group. In addition to the TR sessions, each patient performed the interventions belonging to the group they were included in as a home program (HP), 3 sessions per day for the first 8 weeks of the follow-up period. Patient follow-up, which started from the 1st week after discharge, continued for 12 weeks. The content of the follow-up process was planned to include information, assessment, and PTR interventions. The first 8 weeks of the follow-up period consisted of PTR sessions performed with video-conference-based TR method under the supervision of a physiotherapist and HP, while the last 4 weeks consisted of the follow-up of the walking program performed with telephone-based TR method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• To be over 18 years old
• Undergoing primary unilateral TKA
• To be able to understand, speak and write Turkish,
• be able to understand verbal and written information, have internet access
• be able to use a video conferencing program

Exclusion Criteria:

• To undergo revision TKA
• To have undergone any major surgery on the lower extremities
• Comorbid diseases such as rheumatoid arthritis, cancer, etc,
• Neurological disease causing functional disability
• Have a diagnosed psychiatric disorder
• Being addicted to alcohol or drugs
• Have a hearing or visual impairment that cannot be corrected with hearing aids or glasses,
• Being morbidly obese (BMI>40 kg/m2)
• be unable to participate in a twelve-week rehabilitation program

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy
• Telerehabilitation

Intervention

Other:
• standard exercises
Standard exercises for TKA patients.
• core stability exercises
Core stability exercises for TKA patients.

Locations

Country	Name	City	State
Turkey	Burdur Mehmet Akif Ersoy University	Burdur
Turkey	Pamukkale University	Denizli

Sponsors (2)

Lead Sponsor	Collaborator
Burdur Mehmet Akif Ersoy University	Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional level	Functional level was assessed using the Western Ontario McMaster University Osteoarthritis Index. Western Ontario and McMaster Universities Osteoarthritis Index consists of 24 questions and 3 subcategories (pain, stiffness and physical function). Pain is evaluated with 5 questions, stiffness with 2 questions and physical function with 17 questions. Each question in the Index is scored from 0 (none) to 4 (very severe, very difficult). The total score can be a minimum of 0 and a maximum of 100. In addition, each subcategory can also be evaluated on its own. A higher score on the Index indicates more symptoms and physical disability.	The assessments were performed before surgery and at the first, second and third months after surgery.
Primary	Pain intensity	Pain intensity was assessed using the pain subcategory of Western Ontario McMaster University Osteoarthritis Index and the Visual Analog Scale. There are 5 questions in the pain subcategory of the Western Ontario and McMaster Universities Osteoarthritis Index. Each question in the Index is scored from 0 (none) to 4 (very severe, very difficult). The pain score can be a minimum of 0 and a maximum of 20. A higher pain score indicates more pain. Visual Analog Scale consists of a horizontal 10 cm straight line. When viewed from left to right, there is a value of 0 at the beginning and 10 at the end of the line. The 0 point of the line indicates no pain and the 10 point indicates the most severe pain felt in life.	The assessments were performed before surgery and at the first, second and third months after surgery.
Primary	Knee range of motion	Knee range of motion was assessed using the Copenhagen Knee Range of Motion Scale. In this scale, knee range of motion is assessed based on illustrations. For the knee joint flexion angle, 6 different illustrations are used: 60°, 75°, 90°, 105°, 120° and 135°. For the knee extension angle, 5 different illustrations are used: 45°, 30°, 15°, 0° and -15°.	The assessments were performed before surgery and at the first, second and third months after surgery.
Primary	Health-related quality of life	Health-related quality of life was assessed with the Short Form-12. In the Short Form-12, the physical component summary-12 score is obtained from the physical functioning, physical role, body pain and general health sub-dimensions, while the mental component summary-12 score is obtained from the vitality, social functioning, emotional role and mental health sub-dimensions. Both physical component summary-12 and mental component summary-12 scores range between 0-100, with higher scores indicating better health status.	The assessments were performed before surgery and at the first, second and third months after surgery.
Primary	General quality of life	General quality of life was assessed with the World Health Organization Quality of Life Brief Version. World Health Organization Quality of Life Brief Version consists of 4 domains: physical health, psychological, social relationships and environment. In World Health Organization Quality of Life Brief Version, each domain is scored separately and expressed as a percentage between 0 and 100, with a higher percentage indicating better health.	The assessments were performed before surgery and at the first, second and third months after surgery.
Primary	Lower extremity muscle strength	Lower extremity muscle strength was assessed with the 30-seconds chair-stand test. The number of times the patient stands up completely from the chair within 30 seconds is recorded as the patient's score.	The assessments were performed before surgery and at the first, second and third months after surgery.
Primary	Locomotor performance	Locomotor performance was assessed with the stair climb test. The time taken to ascend and then descend a 9-step staircase was recorded as the patient's score.	The assessments were performed before surgery and at the first, second and third months after surgery.