Action Observation Therapy Via Telerehabilitation on Total Knee Arthroplasty Surgery

NCT06162208 | Unknown DMC

• 1 other identifier: E-60116787-020-39072
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare patient-reported and performance-based outcomes of patients followed with a standard exercise program based on telerehabilitation and patients followed with action observation therapy program added to a standard exercise program based on telerehabilitation after total knee arthroplasty surgery. The main questions it aims to answer are:

• \[What is the effect of action observation therapy added to a telerehabilitation-based standard exercise program on patient-reported outcomes after total knee arthroplasty surgery?\]
• \[What is the effect of action observation therapy added to a telerehabilitation-based standardized exercise program on performance-based outcomes after total knee arthroplasty surgery?\] Participants will be divided into three groups by computer-assisted randomization method: Group 1: home exercise with information leaflet group, Group 2: information leaflet + telerehabilitation-based standard exercise program group, Group 3: information leaflet + telerehabilitation-based standard exercise program + action observation therapy group. Patients in the second and third groups will be followed up with the telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 days a week for 6 weeks after discharge. The third group will receive a standard exercise program 3 days a week and 15 minutes of action observation therapy via video conferencing.

Conditions

Knee Arthroplasty, Total; Telerehabilitation

Keywords

Telerehabilitation; Action Observation Therapy; Total Knee Arthroplasty; Patient-Reported Outcomes; Performance-Based Outcomes

Outcome Measures

Primary Outcomes (7)

• Pain, stiffness and physical function (WOMAC)

  • Western Ontario McMaster University Osteoarthritis Index (WOMAC): This index questions clinically significant problems in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and knee.

  5 minutes

• Pain intensity

  Pain intensity will be assessed with the Visual Analog Scale (VAS).

  2 minutes

• Knee range of motion

  Active and passive knee range of motion will be measured in the sitting position with a digital goniometer (HALO Medical Devices, Australia).

  5 minutes

• Physical activity assessment

  IPAQ-Short Form and smartphone pedometer application (Samsung Health®) will be used for physical activity assessment. The IPAQ-Short Form consists of 7 questions asking about various degrees of physical activity and sedentary behaviors in the past 1 week.

  5 minutes

• Lower extremity muscle strength

  Lower extremity muscle strength will be assessed by 30 seconds sit and stand test.

  30 seconds

• Walking speed

  In the 40-meter walk test, the patient is asked to walk a distance of 40 meters as fast as possible and the time in seconds is recorded.

  Average 5 minutes

• Locomotor performance

  Locomotor performance will be assessed with the stair climbing test. The patient will be asked to ascend and descend 9 steps 16-20 centimeters long stairs as quickly but safely as possible.

  Average 5 minutes

Secondary Outcomes (2)

• Quality of Life Assessment

  10 minutes

• Patient satisfaction assessment

  2 minutes

Study Arms (3)

Home exercise group with information leaflet

NO INTERVENTION

These patients will be asked to do the exercises in the information leaflet themselves at home.

İnformation brochure+standard exercise program group based on telerehabilitation

ACTIVE COMPARATOR

Patients in this group will be followed up with telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 times a week for 6 weeks after discharge.

Other: Standard exercise program based on telerehabilitation

İnformation brochure+standard exercise program+action observation therapy group.

ACTIVE COMPARATOR

Patients in this group will be followed up with telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 times a week for 6 weeks after discharge. In addition, 15 minutes of movement observation therapy will be applied via video conferencing 3 days a week.

Other: Standard exercise program based on telerehabilitation

Interventions

Standard exercise program based on telerehabilitation OTHER

Exercises included in a standard exercise program based on telerehabilitation; Week 0-3 Patellar mobilization Isometric quadriceps femoris exercise Terminal extension exercise Active assisted knee flexion Straight leg lift Active hip abduction Active assisted knee flexion in sitting SAFTE Cold pack application Week 3-6 Straight leg raises with weights Hip abduction in weighted side lying Knee flexion in the prone position Knee extension in weight-bearing sitting Sliding forward in the chair to increase the knee flexion angle Standing weighted hip abduction Standing knee flexion with weight Squat Walking Climbing stairs Action observation therapy will be practiced by watching videos of all exercises with a focus on close-up action.

Also known as: Action observation therapy added to a standard exercise program based on telerehabilitation

İnformation brochure+standard exercise program group based on telerehabilitation; İnformation brochure+standard exercise program+action observation therapy group.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer
• years and older
• Undergo primary unilateral total knee arthroplasty surgery after the diagnosis of osteoarthritis
• Can understand, speak and write Turkish
• Understand verbal and written information given
• Internet access
• Able to use video conferencing program

You may not qualify if:

• Revision total knee arthroplasty surgery
• Previous major surgery on the extremity to be operated on
• Additional comorbid diseases such as rheumatoid arthritis, cancer
• Has any engine defect that may affect performance
• With a diagnosed psychiatric disorder
• People with alcohol or drug addiction
• Hearing or visual impairment that cannot be corrected with hearing aids or glasses
• Morbidly obese (BMI \> 40 kg/m2)
• Who will not be able to participate in a six-week rehabilitation program
• Patients who did not come to follow-up after surgery for any reason,
• Patients who want to leave the study,
• Patients who are unable to continue the study due to an additional condition will be excluded from the study.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20000, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Villafane JH, Isgro M, Borsatti M, Berjano P, Pirali C, Negrini S. Effects of action observation treatment in recovery after total knee replacement: a prospective clinical trial. Clin Rehabil. 2017 Mar;31(3):361-368. doi: 10.1177/0269215516642605. Epub 2016 Jul 10.

  PMID: 27068367 BACKGROUND

• Windsor EN, Sharma AK, Gkiatas I, Elbuluk AM, Sculco PK, Vigdorchik JM. An Overview of Telehealth in Total Joint Arthroplasty. HSS J. 2021 Feb;17(1):51-58. doi: 10.1177/1556331620972629. Epub 2021 Feb 21.

  PMID: 33967642 BACKGROUND

• McKeon JF, Alvarez PM, Vajapey AS, Sarac N, Spitzer AI, Vajapey SP. Expanding Role of Technology in Rehabilitation After Lower-Extremity Joint Replacement: A Systematic Review. JBJS Rev. 2021 Sep 13;9(9). doi: 10.2106/JBJS.RVW.21.00016.

  PMID: 34516463 BACKGROUND

Study Officials

• Sinem Yenil, Msc, PT

  Pamukkale University

  PRINCIPAL INVESTIGATOR

• Harun Reşit Güngör, Prof.

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nevriye Ünal Süzer, Msc, PT

CONTACT

+90 554 274 42 80; nevriyeunal@gmail.com

Nihal Büker, Prof.

CONTACT

+90 258 296 42 73; nasuk@pau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)