OsteoarthritisNCT05209893
The Effect of Telerehabilitation-Based Exercise and Training on Outcome Measures in Patients With Knee Osteoarthritis
A study testing Telerehabilitation and Paper Based Rehabilitation in people with Osteoarthritis and Knee Arthritis, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Video exercise component of the telerehabilitation would provide additional contribution to the patients. The aim of this study is to compare the effects of telerehabilitation-based exercise program and conventional (given on paper) exercise and training combination practices on pain, functionality, balance… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee Arthritis
- What is being tested?
- Telerehabilitation and Paper Based Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2022to 5 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 40 to 65 years
- Being diagnosed with knee osteoarthritis by an orthopedist
- Having a value of 1 or 2 in the Kellgren Lawrence classification
- Having and being able to use the equipment to receive video-based exercise and education support
- Having signed the consent form
Who cannot join
- Situations that will prevent assessments or communication with the individual
- Knee surgery history
- Having other joint pathologies
- 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
About this study
Official title: The Effect of Telerehabilitation-Based Exercise and Training Combination on Pain, Function, Balance, Proprioception and Quality of Life in Patients With Knee Osteoarthritis
Video exercise component of the telerehabilitation would provide additional contribution to the patients. The aim of this study is to compare the effects of telerehabilitation-based exercise program and conventional (given on paper) exercise and training combination practices on pain, functionality, balance, proprioception and quality of life in patients with knee OA.
Read the detailed description
Owing to telerehabilitation, exercise video suppliment will enable individuals to learn the exercise programs in the most appropriate way, have comprehensive information about their condition, and communicate easily with their physiotherapists. The aim of this study is to compare the effects of telerehabilitation-based exercise program and conventional (given on paper) exercise and training combination practices on pain, functionality, balance, proprioception and quality of life in patients with knee OA.
- Conditions
- Osteoarthritis, Knee Arthritis
- Being tested
- Telerehabilitation, Paper Based Rehabilitation
- Keywords
- Gonarthrosis, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
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 knee osteoarthritis
Paper Based RehabilitationOther
Paper instruction based home exercise for the knee osteoarthritis
| 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 Pain 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 Subjective Function 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 Muscle Strength 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 Proprioception at 8 weeks
Timed Up and Go Test (TUG)
Patients are asked to get up from a standard chair, walk 3 meters a safe and comfortable pace, and return without stopping to sit back in the chair safely. The elapsed time is calculated.
Measured: Change from Baseline "Timed Up and Go" test performance at 8 weeks
Five Times Sit to Stand Test (5TSTS)
The test involves patients getting up and sitting again without support from a chair 5 times as soon as possible. Measurements are made with a stopwatch.
Measured: Change from Baseline "Five Times Sit to Stand" test performance at 8 weeks
3-Meter Backward Walk Test (3MBW)
It is determined by measuring a distance of 3 meters. Participants are asked to walk backwards safely but as quickly as possible and stop at the finish line. The time is recorded with a stopwatch.
Measured: Change from Baseline "3-Meter Backward Walk" test performance at 8 weeks
Modified Four Square Step Test (mFSST)
A suitable ground is divided into four identical squares with a "+" shaped line. Squares are numbered clockwise with numbers 1-4. The patient takes steps on the 1, 2, 3 and 4 squares in sequence without pressing the lines.The test ends when the last foot contact is cut off from the square. The time is recorded with a stopwatch.
Measured: Change from Baseline "Modified Four Square Step" test performance at 8 weeks
Secondary outcomes (3)
EQ-5D-5L
The patient is asked to indicate the state of health by marking the most appropriate expression in each of the five dimensions. Index score of the EQ-5D-5L is ranged between 1 to - 0.285. Higher scores indicate better quality of life. VAS score of the EQ-5D-5L is ranged between 0 to 100. Higher scores indicate better quality of life.
Measured: Change from Baseline General Quality of Life at 8 weeks
Telemedicine Satisfaction Questionnaire
This questionnaire consists of 14 items. The level of satisfaction of the patients with the software or system from which they receive treatment or other remote rehabilitation services is evaluated. The tool uses a 5-point Likert scale (1 = strongly disagree, 7 = strongly agree). The total score varies between 14-70 for 14 questions with a maximum of 5 points. Higher scores indicate better satisfaction.
Measured: Change from Baseline General Telemedicine Satisfaction at 8 weeks
Telehealth Usability Questionnaire
The questionnaire consists of 21 items evaluating the distance rehabilitation service. The questionnaire uses a 7-point Likert-type scale (1 = disagree, 7 = agree). The total score is calculated by summing up 21 items.
Measured: Change from Baseline General Usability Satisfaction 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 posted27 Jan 2022
- Study start24 Jan 2022
- Primary completion27 May 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Bakırhan, Ege University
- Investigators
- Fatih Özden, PhD, Principal investigator, Muğla Sıtkı Koçman UniversityCem Yalın Kılınç, MD, Principal investigator, Muğla Sıtkı Koçman UniversityEmre Gültaç, MD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209893
- Sponsor's protocol ID
- 24/III
- Status last verified
- Jul 2022
- First submitted
- 6 Jan 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tumturk I, Bakirhan S, Ozden F, Gultac E, Kilinc CY. Effect of Telerehabilitation-Based Exercise and Education on Pain, Function, Strength, Proprioception, and Psychosocial Parameters in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial. Am J Phys Med Rehabil. 2024 Mar 1;103(3):222-232. doi: 10.1097/PHM.0000000000002335. Epub 2023 Sep 5.
PubMed 37678215
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telerehabilitation-Based Exercise and Training Combination on Pain, Function, Balance, Proprioception and Quality of Life in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05209893
- Acronym / sponsor ID
- 24/III
- Conditions
- Osteoarthritis, Knee Arthritis
- Keywords
- Gonarthrosis, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 27 Jan 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.
Video exercise component of the telerehabilitation would provide additional contribution to the patients. The aim of this study is to compare the effects of telerehabilitation-based exercise program and conventional (given on paper) exercise and training combination practices on pain, functionality, balance, proprioception and quality of life in patients with knee OA.
Detailed description
Owing to telerehabilitation, exercise video suppliment will enable individuals to learn the exercise programs in the most appropriate way, have comprehensive information about their condition, and communicate easily with their physiotherapists. The aim of this study is to compare the effects of telerehabilitation-based exercise program and conventional (given on paper) exercise and training combination practices on pain, functionality, balance, proprioception and quality of life in patients with knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 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
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 40 to 65 years
- Being diagnosed with knee osteoarthritis by an orthopedist
- Having a value of 1 or 2 in the Kellgren Lawrence classification
- Having and being able to use the equipment to receive video-based exercise and education support
- Having signed the consent form
Key exclusion criteria (4 listed)
- Situations that will prevent assessments or communication with the individual
- Knee surgery history
- Having other joint pathologies
- 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 knee osteoarthritis | Other | Telerehabilitation (TR) |
| Paper Based RehabilitationPaper instruction based home exercise for the knee osteoarthritis | Other | Paper Based Rehabilitation (PBR) |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Change from Baseline Pain 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 Subjective Function 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).
Muscle Strength Test with Lafayette Hand Held Dynamometer
Time frame: Change from Baseline Muscle Strength 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 Proprioception 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.
Timed Up and Go Test (TUG)
Time frame: Change from Baseline "Timed Up and Go" test performance at 8 weeks
Patients are asked to get up from a standard chair, walk 3 meters a safe and comfortable pace, and return without stopping to sit back in the chair safely. The elapsed time is calculated.
Five Times Sit to Stand Test (5TSTS)
Time frame: Change from Baseline "Five Times Sit to Stand" test performance at 8 weeks
The test involves patients getting up and sitting again without support from a chair 5 times as soon as possible. Measurements are made with a stopwatch.
3-Meter Backward Walk Test (3MBW)
Time frame: Change from Baseline "3-Meter Backward Walk" test performance at 8 weeks
It is determined by measuring a distance of 3 meters. Participants are asked to walk backwards safely but as quickly as possible and stop at the finish line. The time is recorded with a stopwatch.
Modified Four Square Step Test (mFSST)
Time frame: Change from Baseline "Modified Four Square Step" test performance at 8 weeks
A suitable ground is divided into four identical squares with a "+" shaped line. Squares are numbered clockwise with numbers 1-4. The patient takes steps on the 1, 2, 3 and 4 squares in sequence without pressing the lines.The test ends when the last foot contact is cut off from the square. The time is recorded with a stopwatch.
3 secondary outcomes
EQ-5D-5L
Time frame: Change from Baseline General Quality of Life at 8 weeks
Telemedicine Satisfaction Questionnaire
Time frame: Change from Baseline General Telemedicine Satisfaction at 8 weeks
Telehealth Usability Questionnaire
Time frame: Change from Baseline General Usability Satisfaction 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 21 Jul 2022.
- Derived from this study: PubMed 37678215Tumturk I, Bakirhan S, Ozden F, Gultac E, Kilinc CY. Effect of Telerehabilitation-Based Exercise and Education on Pain, Function, Strength, Proprioception, and Psychosocial Parameters in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial. Am J Phys Med Rehabil. 2024 Mar 1;103(3):222-232. doi: 10.1097/PHM.0000000000002335. Epub 2023 Sep 5.
- 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.
Fatih Özden, PhD principal investigator
Muğla Sıtkı Koçman University
Cem Yalın Kılınç, MD principal investigator
Muğla Sıtkı Koçman University
Emre Gültaç, MD 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 Osteoarthritis and Knee Arthritis, run by Ege 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 5 inclusion and 4 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 21 Jul 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 Pain at 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05209893, which also lists 1 linked publication.
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 21 Jul 2022.