Effects of Different Telerehabilitation Methods on Pain, Functional Limitation, Muscle Strength, Balance, and Quality of Life in Patients With Knee Osteoarthritis.
Comparison of the Effects of Different Telerehabilitation Methods on Pain, Functional Limitation, Muscle Strength, Balance, and Quality of Life in Patients With Knee Osteoarthritis.
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The aim of our study is; To compare the effectiveness of asynchronous and synchronous telerehabilitation programs on pain, functional limitation, muscle strength, balance and quality of life parameters in patients with knee osteoarthritis. 60 patients with knee osteoarthritis who applied to Marmara University Faculty of Health Sciences Physiotherapy and Rehabilitation Department will be included in our study. The treatment and evaluations to be made will be explained and their consent will be obtained with their signatures. Patients will be randomly assigned to the asynchronous telerehabilitation group (n= 30 patients) and the synchronous telerehabilitation group (n= 30 patients). In the asynchronous telerehabilitation group, the rehabilitation program will be carried out via a mobile application (Diabetex). The coordinator will forward the exercise programs prepared specifically for the patients to the relevant participants through the application. On the other hand, telerehabilitation in the synchronous group will be carried out via video conference (Zoom). Patients will be taken to video conference calls and will perform their exercises simultaneously under the guidance of the researcher. An exercise program including lower extremity strengthening and stretching exercises will be applied to all patients. In both groups, the exercise program will be applied 3 days a week for 8 weeks, 1 session per day and 45 minutes per session. All outcome parameters will be evaluated by a blinded assessor who has not seen patients before. Patients starting the rehabilitation program will be evaluated at the beginning of the study, at weeks 4, 8, and 16. The information of the patients participating in the study will be taken with the demographic data form. Pain in patients will be measured with the Visual Analog Scale, while the functionality of the patients will be evaluated with the WOMAC osteoarthritis index and the Lysholm Knee Scoring Scale. In addition, the affected quality of life of the patients will be evaluated with the Patient Generated Index and Short Form-12 scales. While the functional mobility of the patients was evaluated with the Timed Up and Go Test; functional capacities 2 Minute Walk Test, and lower extremity neuromuscular function levels 30 sec. It will be evaluated with Sit and Stand and 5 Sit and Stand performance tests. In addition, the Unilateral Posture Test, Limits of Stability Test, Sit and Stand Up Test will be performed using the NeuroCom Balance Master Posturography device for balance evaluation, and knee flexion and extension muscle strength and proprioception will be evaluated with the Isokinetic device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedAugust 24, 2022
August 1, 2022
3 months
August 12, 2022
August 22, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index
The WOMAC osteoarthritis index is a 24-item scale that examines three dimensions: pain, stiffness, and physical function. Each question is scored on a Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The score of each section is calculated on its own and the total score ranges from 0 to 100. High scores indicate increased pain and stiffness and impaired physical function.
The WOMAC will be measured at baseline 2 minutes after pain assessment.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index
The WOMAC osteoarthritis index is a 24-item scale that examines three dimensions: pain, stiffness, and physical function. Each question is scored on a Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The score of each section is calculated on its own and the total score ranges from 0 to 100. High scores indicate increased pain and stiffness and impaired physical function.
The WOMAC will be measured at the end of intervention (8. week) 2 minutes after pain assessment.
Visual analogue scale (VAS)
Pain will be measured using a 10 cm visual analogue scale (VAS). The participants places a mark on the line that best represented their perception of pain at that instant. The VAS score will be measured in cm from the left hand end of the line to the mark.
The pain will be measured at study entry (baseline) after inclusion.
Visual analogue scale (VAS)
Pain will be measured using a 10 cm visual analogue scale (VAS). The participants places a mark on the line that best represented their perception of pain at that instant. The VAS score will be measured in cm from the left hand end of the line to the mark.
The pain will be measured at the end of intervention (8. week).
Secondary Outcomes (8)
12-Item Short Form Survey (SF-12)
The SF-12 will be measured at baseline 2 minutes after WOMAC assessment.
12-Item Short Form Survey (SF-12)
The SF-12 will be measured at the end of intervention (8. week) 2 minutes after WOMAC assessment.
30 Seconds Sit To Stand Test
The 30 Seconds Sit To Stand Test will be measured baseline 2 minutes after SF-12 assessment.
30 Seconds Sit To Stand Test
The 30 Seconds Sit To Stand Test will be measured at the end of intervention (8. week) 2 minutes after SF-12 assessment.
2 Minute Walk Test
The 2 Minute Walk Test will be measured at baseline 5 minutes after 30 Seconds Sit To Stand Test assessment.
- +3 more secondary outcomes
Study Arms (2)
Synchronous Telerehabilitation Group
ACTIVE COMPARATORSynchronous Telerehabilitation Group will receive exercise therapy via video conference.
Asynchronous Telerehabilitation Group
EXPERIMENTALAsynchronous Telerehabilitation Group will receive exercise therapy via mobile application.
Interventions
The intervention will include the different levels of the following exercises that are given to the patient considering their functional level: 1. Straight leg raise (Level 1-2-3) 2. Quadriceps strengthening (Level 1-2-3) 3. Hip abductor/adductor strengthening (Level 1-2-3) 4. Hamstring stretch 5. Gastrocnemius stretch
The intervention will include the different levels of the following exercises that are given to the patient considering their functional level: 1. Straight leg raise (Level 1-2-3) 2. Quadriceps strengthening (Level 1-2-3) 3. Hip abductor/adductor strengthening (Level 1-2-3) 4. Hamstring stretch 5. Gastrocnemius stretch
Eligibility Criteria
You may qualify if:
- Pain less than or equal to 7 according to VAS
- Individuals aged 18-65
- Patients with independent mobility
You may not qualify if:
- Patients who have undergone surgery in the last 1 year
- Patients who have undergone total knee replacement or total hip replacement surgery
- Patients with acute trauma in the last 1 year
- Patients with uncontrolled chronic disease
- Patients who have received physical therapy in the last 6 months
- Patients who have received hyaluronic acid and corticosteroid injections in the last 6 months
- Patients with a respiratory condition that interferes with walking will not be included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Assoc Prof
Study Record Dates
First Submitted
August 12, 2022
First Posted
August 24, 2022
Study Start
September 1, 2022
Primary Completion
December 10, 2022
Study Completion
February 1, 2023
Last Updated
August 24, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share