- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05233839
Efficacy of Telerehabilitation in Patients With Degenerative Meniscal Injury
August 27, 2022 updated by: Fatih Ozden, Muğla Sıtkı Koçman University
The Effect of Telerehabilitation and Conventional Rehabilitation on Clinical Outcomes and Exercise Compliance in Patients With Degenerative Meniscal Injury
The aim of the study is to compare the home exercise program performed with video-based telerehabilitation in patients with degenerative meniscal injury, and the home exercise program performed with one-on-one training in the hospital with conventional methods.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Conventional rehabilitation (CR) practices will be applied to the first study group.
Telerehabilitation (TR) application will be applied to the second study group.
It is aimed to evaluate the patients in terms of pain, functionality, quality of life and exercise compliance.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Menteşe
-
Muğla, Menteşe, Turkey, 48000
- Muğla Sıtkı Koçman Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female patients aged 18 - 65 years
- Having been diagnosed with degenerative meniscus injury by an orthopedist by MRI examination
- Having signed the consent form
Exclusion Criteria:
- Situations that will prevent assessments or communication with the individual
- Having an operation due to degenerative meniscus injury problem
- Orthopedic and neurological problems that would prevent evaluation and/or treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehabilitation (TR)
The TR group will be followed up through the application within the 8-week home exercise program.
|
Application based video home exercise for the degenerative meniscus injury
|
|
Active Comparator: Paper Based Rehabilitation (PBR)
The PBR group will be followed up through the paper instruction within the 8-week home exercise program.
|
Paper instruction based home exercise for the degenerative meniscus injury
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Change from Baseline VAS at 8 weeks
|
On a 10 cm straight line or numerical scale (0: no pain, 10: unbearable pain).
|
Change from Baseline VAS at 8 weeks
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Change from Baseline WOMAC at 8 weeks
|
WOMAC consists of 3 main headings: pain intensity, stiffness, and physical function.
The total score ranges from 0 (no disability) to 96 (complete disability).
|
Change from Baseline WOMAC at 8 weeks
|
|
SF-12
Time Frame: Change from Baseline SF-12 at 8 weeks
|
SF 12 is a self-evaluation scale.
It consists of seven items.
Its score ranged from 0 to 100, with higher scores indicating better physical and mental health functioning.
|
Change from Baseline SF-12 at 8 weeks
|
|
Muscle Strength Test with Lafayette Hand Held Dynamometer
Time Frame: Change from Baseline Dynamometer Value at 8 weeks
|
It is an objective muscle strength measurement tool.
Measurements are made 3 times.
A rest of 120 seconds is given between measurements.
The highest measured value is noted.
|
Change from Baseline Dynamometer Value at 8 weeks
|
|
Proprioception Measurement with Baseline Bubble Inclinometer
Time Frame: Change from Baseline Inclinometer Value at 8 weeks
|
The "absolute angle difference", which is the difference between the targeted angle and the angle realized by the patient in each repetition, is recorded.
The arithmetic mean of the absolute angle difference of 3 repetitions is the result data.
|
Change from Baseline Inclinometer Value at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EARS
Time Frame: Change from Baseline EARS at 8 weeks
|
In order to observe the individual's adaptation to exercise, the motivation levels of the patients regarding the exercise program are evaluated with the exercise diary prepared by the researchers of the study.
It is scored between 0 to 24.
Higher scores indicate greater adherence.
|
Change from Baseline EARS at 8 weeks
|
|
TSUQ
Time Frame: Change from Baseline TSUQ at 8 weeks
|
It consists of 21 items.
With this survey, the satisfaction levels and usability of individuals using the telemedicine service are evaluated.
The total score is scored between 17 and 85.
Higher scores indicate higher satisfaction and usability.
|
Change from Baseline TSUQ at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: İsmet Tümtürk, BSc, Ege University
- Principal Investigator: Cem Yalın Kılınç, PhD, Muğla Sıtkı Koçman University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
January 13, 2022
First Submitted That Met QC Criteria
January 31, 2022
First Posted (Actual)
February 10, 2022
Study Record Updates
Last Update Posted (Actual)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 27, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Mugla
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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