NCT05875480

Brief 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 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

April 17, 2023

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    6 minutes

  • 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.

    1-2 minutes

  • 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.

    less than 1 minute

Secondary Outcomes (2)

  • Functional knee assessment

    5-6 minutes

  • General health profile

    5-6 minutes

Study Arms (3)

synchronized telerehabilitation group

EXPERIMENTAL

Patients in the synchronized telerehabilitation group had taken real time videoconferencing rehabilitation by physiotherapist 2 times a week, during 4 weeks.

Procedure: synchronized telerehabilitation

asynchronized telerehabilitation group

EXPERIMENTAL

Patients in the asynchronized telerehabilitation group had done the postoperative rehabilitation with exercise videos via application.

Procedure: asynchronized telerehabilitation

supervized conventional rehabilitation group

ACTIVE COMPARATOR

Patients in the supervised physiotherapy group had taken their rehabilitation sessions in the physiotherapy department of the hospital twice a week, during 4 weeks.

Procedure: supervised (face to face) rehabilitation

Interventions

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.

synchronized telerehabilitation group

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.

asynchronized telerehabilitation group

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.

supervized conventional rehabilitation group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maslak Acıbadem Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Dilber Coşkunsu, Assoc. Prof.

    Fenerbahçe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD(c)

Study Record Dates

First Submitted

April 17, 2023

First Posted

May 25, 2023

Study Start

September 23, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations