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

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.

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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