- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06101355
Effectiveness of Telerehabilitation in Total Knee Arthroplasty
Comparison of the Effectiveness of Telerehabilitation in Individuals With Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary aim of our study is to assess the effectiveness of telerehabilitation in comparison to the conventional approach, specifically focusing on particular parameters, in the context of post-total knee arthroplasty surgery. This investigation will entail a comparative analysis between a home exercise program prescription supplemented with visual and video resources using telerehabilitation and the conventional home exercise program prescription.
The aim of our study is comparison between two exercise prescription modalities : a standard home exercise program and an internet-based program utilizing the Rehab My Patient software with visual and video support, in addition to telerehabilitation program, which involves exercise prescription oversight via video consultations. This comparison will include the following parameters : range of motion, proprioception , function, kinesiophobia, pain , patient adherence, patient satisfaction and Quadriceps muscle strength.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey, 06000
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants aged 50 and over
- Having a primary total knee arthroplasty surgery
- To possess a device, such as a smartphone or tablet, that enables access to mobile applications.
- To have the capability to use the internet and to have internet access.
- Proficiency in reading and writing in the Turkish language
- Having a Mini-Mental State Examination(MMSE) score of 24 or higher
- To be willing to participate in the study
Exclusion Criteria:
- Having cognitive problem
- Having a secondary total knee arthroplasty surgery
- Havig a revision surgery
- Having a history of cerebrovascular and/or cardiovascular events in the last 3 months
- Having uncontrolled diabetes and/or hypertension
- Having a arthrogenic muscle inhibition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Telerehabilitation Group Based on Home Exercises
Intervention group is home exercise program supplemented with visual and video resources using telerehabilitation.
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Intervention group is home exercise program supplemented with visual and video resources using telerehabilitation. With the exercises, there will be video links, exercise visuals, and written explanations. Videos and visuals of the exercises recorded by the physiotherapist and uploaded to the Rehab My Patient application. Digital exercise forms will be prepared through the Rehab My Patient application. The intervention group will receive exercises, which prepared from the Rehab My Patient application ,digitally through WhatsApp. In this group, exercise sessions will be conducted with the physiotherapist once a week through video calls. Additionally, there will be one instance of messaging and one phone call for follow-up. Video calls and messaging will be conducted through WhatsApp. |
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Active Comparator: Standard Home Exercise Group
Standard home based exercise group
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Control group, standard home exercise program group , will receive the program as brochures.
Although there will be no video supplement, the brochure will include visuals of the exercises.
The control group will be monitored through three weekly voice calls.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Flexion Range of Motion of the Knee
Time Frame: Postoperatively first day, fourth week and eight week
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Assessment of active and passive flexion range of motion of both knee with digital goniometer
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Postoperatively first day, fourth week and eight week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Demographic Data
Time Frame: Postoperatively first day
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The demographic data such as gender,age, body weight and height, comorbidities of the individuals included the study will be recorded
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Postoperatively first day
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Mental State
Time Frame: Postoperatively first day
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Mini Mental State Examination consists of 30 questions.The test results range from 0 to 30 points.
A score of 0-10 points indicates severe impairment, 10-20 points suggests moderate impairment, 20-25 points indicate mild impairment, and a score of 25-30 points is considered normal.
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Postoperatively first day
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Range of Motion
Time Frame: Postoperatively first day, fourth week and eight week
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Assessment of range of motion of the knee including active and passive flexion and extension by digital goniometer
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Postoperatively first day, fourth week and eight week
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Assessment of Pain
Time Frame: Postoperatively first day, fourth week and eight week
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Assessment the pain while rest, night and activity by using Visual Analog Scale which is a 100 mm line drawn laterally on an A4 sheet of paper.
The left end of the line shows "no pain at all", the right end shows "my pain is as bad as it could be", while the remaining part shows the intermediate values.
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Postoperatively first day, fourth week and eight week
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Assessment of Kinesiophobia
Time Frame: Postoperatively first day, fourth week and eight week
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Assessment of kinesiophobia via Brief Fear of Movement.
This scale consists of 6 items, which are items 1, 2, 9, 10, 14, and 15 from the Tampa Scale for kinesiophobia.
It is a valid approach for assessing movement fear in patients with osteoarthritis
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Postoperatively first day, fourth week and eight week
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Assessment of Artificial Joint Awareness
Time Frame: Postoperatively fourth week and eight week
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Assessment of artificial joint awareness via Forgotten Joint Score-12.
This scale consists of 12 items.Item 12 of the scale has not been considered suitable for use in the Turkish population.
High scores reflect the degree to which one can forget and adapt to the side of the surgery, typically represented as a percentage
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Postoperatively fourth week and eight week
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Assessment of Pain, Stiffness and Physical Function
Time Frame: Postoperatively first day, fourth week and eight week
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Assessment of pain, stiffness and physical function via WOMAC(The Western Ontario and McMaster Universities).
The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions).
The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points.
Higher scores indicates higher disability.
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Postoperatively first day, fourth week and eight week
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Assessment of Patient Adherence
Time Frame: Postoperatively fourth week and eight week
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Assessment of patient adherence via The Exercise Adherence Rating Scale.
The scale consists of three sections: Part A, Part B, and Part C. Part A and Part B each consist of 6 questions, while Part C comprises 10 items.The total score ranges from 0 to 64.
A high score indicates better adherence to exercise or a higher level of exercise compliance.
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Postoperatively fourth week and eight week
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Assessment of Function
Time Frame: Postoperatively first day, fourth week and eight week
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5 Times Sit to Stand Test
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Postoperatively first day, fourth week and eight week
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Assessment of Telemedicine Satisfaction and Usefulness
Time Frame: Postoperatively fourth week and eight week
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Assessment of Telemedicine Satisfaction and Usefulness via Telemedicine Satisfaction and Usefulness Questionnaire(TSUQ). TSUQ consists of 21 items.This questionnaire assesses the satisfaction levels and usability of telemedicine services among individuals.
The total score range from 21 to 105.
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Postoperatively fourth week and eight week
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Assessment of Quadriceps Muscle Strength
Time Frame: Postoperatively fourth week and eight week
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Assessment of Quadriceps Muscle Strength via Lafayette Manual Muscle Tester.The Lafayette Manual Muscle Tester is used for the objective evaluation of muscle strength.
It has both intra-rater and inter-rater reliability and is an ideal tool for tracking progress throughout the rehabilitation process.
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Postoperatively fourth week and eight week
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sema Nur Aslan, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Telerehabilitation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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