Core Stability Via Telerehabitation on TKA

NCT06159205 | Completed DMC

• 1 other identifier: ErsoyU.E-60116787-020-90137
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Knee Arthropathy; Telerehabilitation

Keywords

total knee arthroplasty; exercise; core stability; telerehabilitation; physiotherapy

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Group 1: SE Group

EXPERIMENTAL

SE: standard exercises During the follow-up period, only the interventions included in the standard exercise program were applied to the SE Group.

Other: standard exercises

Group 2: SE + CSE Group

EXPERIMENTAL

CSE: core stability exercises During the follow-up period interventions included in both the standard and core stability program were applied to the SE + CSE group.

Other: standard exercises; Other: core stability exercises

Interventions

standard exercises OTHER

Standard exercises for TKA patients.

Group 1: SE Group; Group 2: SE + CSE Group

core stability exercises OTHER

Core stability exercises for TKA patients.

Group 2: SE + CSE Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead
• Pamukkale University: collaborator

Study Sites (2)

Burdur Mehmet Akif Ersoy University

Burdur, 15100, Turkey (Türkiye)

Location

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Akın Süzer, PT, PhD

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

• Nihal Büker, PT, PhD

  Pamukkale University

  STUDY DIRECTOR

• Harun R Güngör, MD, PhD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

• Nusret Ök, MD, PhD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

• Raziye Şavkın, PT, PhD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study was designed as a double-blind, randomised controlled trial.

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: December 6, 2023
• Study Start: September 1, 2021
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)