Meniscus; DegenerationNCT05233839
Efficacy of Telerehabilitation in Patients With Degenerative Meniscal Injury
A study testing Telerehabilitation and Paper Based Rehabilitation in people with Meniscus; Degeneration, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meniscus; Degeneration
- What is being tested?
- Telerehabilitation and Paper Based Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Sıtkı Koçman Training and Research Hospital
Muğla, Menteşe, 48000
About this study
Official title: 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.
Read the 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.
- Conditions
- Meniscus; Degeneration
- Being tested
- Telerehabilitation, Paper Based Rehabilitation
- Keywords
- Degenerative meniscus injury, Telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Application based video home exercise for the degenerative meniscus injury
Paper Based RehabilitationOther
Paper instruction based home exercise for the degenerative meniscus injury
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation (TR) | Experimental | The TR group will be followed up through the application within the 8-week home exercise program. Receives: Other: Telerehabilitation |
| Paper Based Rehabilitation (PBR) | Active comparator | The PBR group will be followed up through the paper instruction within the 8-week home exercise program. Receives: Other: Paper Based Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
On a 10 cm straight line or numerical scale (0: no pain, 10: unbearable pain).
Measured: Change from Baseline VAS at 8 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC consists of 3 main headings: pain intensity, stiffness, and physical function. The total score ranges from 0 (no disability) to 96 (complete disability).
Measured: Change from Baseline WOMAC at 8 weeks
SF-12
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.
Measured: Change from Baseline SF-12 at 8 weeks
Muscle Strength Test with Lafayette Hand Held Dynamometer
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.
Measured: Change from Baseline Dynamometer Value at 8 weeks
Proprioception Measurement with Baseline Bubble Inclinometer
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.
Measured: Change from Baseline Inclinometer Value at 8 weeks
Secondary outcomes (2)
EARS
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.
Measured: Change from Baseline EARS at 8 weeks
TSUQ
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.
Measured: Change from Baseline TSUQ at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start15 Mar 2022
- Primary completion30 Jun 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus; DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- İsmet Tümtürk, BSc, Principal investigator, Ege UniversityCem Yalın Kılınç, PhD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233839
- Sponsor's protocol ID
- Mugla
- Status last verified
- Aug 2022
- First submitted
- 13 Jan 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telerehabilitation and Conventional Rehabilitation on Clinical Outcomes and Exercise Compliance in Patients With Degenerative Meniscal Injury
- ClinicalTrials.gov ID
- NCT05233839
- Acronym / sponsor ID
- Mugla
- Conditions
- Meniscus; Degeneration
- Keywords
- Degenerative meniscus injury, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation (TR) | Experimental | Other: TelerehabilitationThe TR group will be followed up through the application within the 8-week home exercise program. |
| Paper Based Rehabilitation (PBR) | Active comparator | Other: Paper Based RehabilitationThe PBR group will be followed up through the paper instruction within the 8-week home exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationApplication based video home exercise for the degenerative meniscus injury | Other | Telerehabilitation (TR) |
| Paper Based RehabilitationPaper instruction based home exercise for the degenerative meniscus injury | Other | Paper Based Rehabilitation (PBR) |
Primary outcome
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).
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).
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.
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.
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.
2 secondary outcomes
EARS
Time frame: Change from Baseline EARS at 8 weeks
TSUQ
Time frame: Change from Baseline TSUQ at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İsmet Tümtürk, BSc principal investigator
Ege University
Cem Yalın Kılınç, PhD principal investigator
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Paper Based Rehabilitation in people with Meniscus; Degeneration, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Change from Baseline VAS at 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.