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TelerehabilitationNCT05875480

The Effectiveness of Telerehabilitation After Arthroscopic Meniscus Repair

A study testing synchronized telerehabilitation, asynchronized telerehabilitation and supervised (face to face) rehabilitation in people with Telerehabilitation and Meniscus Tear, run by Bahçeşehir University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was performed on 42 patients, who underwent arthroscopic meniscus repair surgery in the Orthopedics and Traumatology Department of Acıbadem Maslak Hospital. 42 patients randomly assigned to 14 synchronized telerehabilitation, 14 asynchronous telerehabilitation, 14 conventional physiotherapy groups and… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Telerehabilitation, Meniscus Tear, Physiotherapy
What is being tested?
synchronized telerehabilitation, asynchronized telerehabilitation and supervised (face to face) rehabilitation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Sep 2021to 30 Apr 2023
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • In the 18-50 age range,
  • repairable, stable, longitudinal vertical longitudinal or bucket handle meniscus lesion,
  • persons who volunteered to participate in the study

Who cannot join

  • Meniscus root repair,
  • Associated anterior cruciate ligament reconstruction,
  • Other ligament injuries or laxity,
  • Cartilage lesion larger than 2 cm² in size and more than half the thickness of the cartilage (International Society for Cartilage Research [ICRS] grade 3 or 4),
  • previous meniscus or ligament surgery,
  • presence of congenital lower extremity deformity,
Show all 9Show fewer
  • hip and ankle joint pathologies,
  • the presence of systemic diseases affecting the joints such as rheumatoid arthritis
  • lack of ability to follow the established rehabilitation program

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Maslak Acıbadem Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Compare the Effects of Telerehabilitation and Conventional Rehabilitation After Artroscopic Meniscus Surgery

This study was performed on 42 patients, who underwent arthroscopic meniscus repair surgery in the Orthopedics and Traumatology Department of Acıbadem Maslak Hospital. 42 patients randomly assigned to 14 synchronized telerehabilitation, 14 asynchronous telerehabilitation, 14 conventional physiotherapy groups and included in the study. The evaluation form created for the provision of demographic information are used.

Primary outcome measures are muscle strength, range of motion (ROM) and pain intensity.

Read more

Secondary outcome measures are general health profile and functional status assessment of the knee joint .

Evaluation methods: All evaluations were performed in the preoperative period, 10. day, 6. week and 6. month postoperatively. ROM and pain measurements repeated every week during the 6-week rehabilitation process.

Pain, general health profile and functional status assessment of the knee joint were assessed via a telerehabilitation application, Albert Health Assistant.

Postoperative first day, the 14-day exercise program was taught to all patients practically and was given as a brochure.

Patients in the synchronized telerehabilitation group started physiotherapy postoperative 14. day, met with the physiotherapist in real time via the Albert Health Assistant application and they were treated 2 days a week until 6. week. In the remaining days, they asked to follow the exercise videos uploaded to the Albert system, it was checked whether they are doing daily exercises, and a daily reminder message was sent via the system.

The exercise program for the asynchronous telerehabilitation group was uploaded to the Albert Health Assistant as a video from the 14th day in the form of 2-week programs. It was checked over the system whether the patients apply these videos on a daily basis, and a message reminding the daily routine exercise program was sent through the system.

Patients in the supervised physiotherapy group started to take supervized rehabilitation after 10-14 days postoperatively, 2 times a week until 6th week postoperatively in Maslak Acıbadem Hospital Orthopedics and Traumatology Department. ROM, Pain, functional and general health evaluations of the patients in this group were performed on the online platform. In addition, daily routine exercises will be followed over the Albert system on the days they do not come for treatment.

Read the detailed description

Albert Health Assistant is an artificial intelligence-based digital health assistant that helps patients with their treatment. Albert is a healthcare assistant who ensures that patients take their medications at the right dose and at the right time, helps them with treatment compliance, and allows patient relatives and the attending physician to closely monitor the patient's treatment. Albert is a mobile software and sensitive qualified personal health data (patient information) are stored in accordance with the personal data protection law. n this process, which will be created with the Albert treatment tracking system, the following data types can be tracked remotely.

Primary Outcome measures:

Joint Range of Motion (ROM) measurement: Passive hyperextension angles was measured with the knee in active flexion and prone position (with gravity effect).

Joint range of motion measurement was performed with Dr Goniometer, a smartphone app. With this application, a photograph was taken from the patient at the maximum flexion angle that he can perform, and the measurement was made by placing markers on the reference points determined on the photograph. This application is found to be reliable in measuring the knee joint angle.

Muscle strength measurement: It was performed with a Lafayette hand dynamometer. The maximal isometric muscle strength of the hamstring and quadriceps muscles were tested 3 times and the average of 3 measurements were taken. The contraction time is 5 seconds, the rest time is 10 seconds, there was a resting period of 2 minutes in the tests between the two muscles. Measurements will be performed by placing the dynamometer on the distal 1/3 of the thigh while the prone knee is in the 45 degree flexion position.

Pain assessment: Visual Pain Scale (VAS) was used. VAS is a scale between 0-10 points. 0 corresponds to no pain, 10 corresponds to unbearable pain. It is a validated scale in which the patient self-assesses his pain at the time of evaluation.

Secondary Outcomes:

General Health profile measurement: It will was performed using the PROMIS 29 Health Profile Questionnaire. The Patient-Reported Outcomes Measurement Information System (PROMIS) is a general health scale created by the National Institutes of Health, in which the patient can self-report to assess functioning and well-being in the physical, mental and social areas of health.

IKDC subjective knee form: The IKDC (International Knee Documentation Committee) subjective knee form is designed to measure symptoms and limitations in function and sports activity for various knee conditions, including ligament, meniscus, and cartilage injuries, as well as patellofemoral pain.

Being tested
synchronized telerehabilitation, asynchronized telerehabilitation, supervised (face to face) rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • synchronized telerehabilitationProcedure or surgery

    In the synchronized telerehabilitation group, the exercise program of the first 2 weeks was submitted via Albert Health Assistant application and patients were asked to do these exercises regularly during this process. after 2 weeks, they were treated 2 days a week until the 6th week by meeting with the physiotherapist in real time via the Albert Health Assistant application. In the remaining days, they were asked to follow the exercise videos uploaded to the Albert system, it will be checked whether they have done the daily exercises, and a daily reminder message will be sent through the system.

  • asynchronized telerehabilitationProcedure or surgery

    The exercise program for the asynchronized telerehabilitation group will be uploaded to the Albert Health Assistant in the form of 2-week programs in video form from the first Day. Whether the patients apply these videos on a daily basis will be checked through the system, a message reminding the daily routine exercise program will be sent through the system.

  • supervised (face to face) rehabilitationProcedure or surgery

    In the supervised physiotherapy group, the exercise program of the first 2 weeks was submitted via Albert Health Assistant application and patients were asked to do these exercises regularly during this process. After 2 weeks, they attended the rehabilitation program in the physical therapy department of the hospital accompanied by a physiotherapist, starting from the 14th postoperative day, 2 days a week until the 6th week. The ROM, pain, functional and general health evaluations of the patients in this group were carried out on the online platform. In addition, on the days when they did not come to treatment, their daily routine exercises were followed through the Albert system.

Study groups in NCT05875480
Study groupRoleWhat they receive
synchronized telerehabilitation groupExperimentalPatients in the synchronized telerehabilitation group had taken real time videoconferencing rehabilitation by physiotherapist 2 times a week, during 4 weeks.
Receives: Procedure: synchronized telerehabilitation
asynchronized telerehabilitation groupExperimentalPatients in the asynchronized telerehabilitation group had done the postoperative rehabilitation with exercise videos via application.
Receives: Procedure: asynchronized telerehabilitation
supervized conventional rehabilitation groupActive comparatorPatients in the supervised physiotherapy group had taken their rehabilitation sessions in the physiotherapy department of the hospital twice a week, during 4 weeks.
Receives: Procedure: supervised (face to face) rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle strength

    Muscle strength measurements were made with a Lafayette hand dynamometer. The maximal isometric muscle strength of the hamstring and quadriceps muscles was tested 3 times and the average of 3 measurements was taken. The contraction time was 5 seconds, the rest time was 10 seconds, and a 2-minute rest period was given in the tests between the two muscles. Measurements were made with the prone knee in the 45 degree flexion position, with the dynamometer placed on the distal 1/3 of the thigh.

    Measured: 6 minutes

  2. Range of motion of knee joint

    Range of motion measurement was performed every week between the 1st-6th weeks postoperatively and once in the 6th month. Passive hyperextension angles of the knee were measured in active flexion and prone position (with the effect of gravity).

    Joint range of motion measurement was performed with Dr Goniometer, a smartphone application. With this application, a photograph was taken from the patient at the maximum flexion angle that he could achieve, and the measurement was made by placing markers on the reference points determined on the photograph.

    Measured: 1-2 minutes

  3. Pain intensity

    Visual Pain Scale (VAS) was used. VAS is a scale between 0-10 points. 0 corresponds to no pain, 10 corresponds to unbearable pain. It is a validated scale in which the patient self-assesses their pain at the time of assessment.

    Measured: less than 1 minute

Secondary outcomes (2)
  1. Functional knee assessment

    It was evaluated using the IKDC (International Knee Documentation Committee) subjective knee form. This form is designed to measure symptoms and limitations in function and sporting activity for a variety of knee conditions, including ligament, meniscus and cartilage injuries, as well as patellofemoral pain.

    Measured: 5-6 minutes

  2. General health profile

    It was conducted using the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Health Profile Questionnaire. PROMIS -29 is a general health scale created by the National Institutes of Health, where the patient can self-report to assess functioning and well-being in the physical, mental and social areas of health. It includes 28 items from seven PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) and a single item on pain intensity.Each item has five response options (values 1 to 5), except for the pain intensity item which has eleven response options (values 0 to 10). A total raw score is computed for each domain as the sum of the response to each question within the domain, leading to seven domain scores, each from 4 to 20.

    Measured: 5-6 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study start23 Sep 2021
  3. Primary completion30 Apr 2023
  4. Study completion30 Apr 2023

Resources

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05875480
Sponsor's protocol ID
BahcesehirUniversitiy
Status last verified
May 2023
First submitted
17 Apr 2023
Last updated
25 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing synchronized telerehabilitation, asynchronized telerehabilitation and supervised (face to face) rehabilitation in people with Telerehabilitation and Meniscus Tear, run by Bahçeşehir 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 9 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 25 May 2023. 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?

Muscle strength (time frame: 6 minutes). The study lists 3 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 25 May 2023.

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