Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation in Patients with Juvenile Familial Mediterranean Fever

December 16, 2024 updated by: Aysenur Namli, Istanbul University - Cerrahpasa

Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation on Fatigue and Functional Capacity in Juvenile Familial Mediterranean Fever Patients

Our study will be randomized controlled. Familial Mediterranean Fever patients between the ages of 12-18 will be included in the study and will be divided into 2 groups. The first group will be applied a synchronous supervised online exercise program under the supervision of a physiotherapist, and the second group will be applied an asynchronous video-based exercise program. The exercise program will be carried out for 8 weeks, 2 days a week. There will be 3 sets, 8 repetitions in 1 set in the exercise program and will be progressed according to tolerance. In the exercise program, the synchronous group will perform the exercises with the supervision of a physiotherapist via the Zoom application, while the asynchronous video-based group will upload the exercises to the system asynchronously via a channel on YouTube that only patients can access. Feedback will be received from the asynchronous group by phone. Our exercise program will be organized with the progression of exercises such as squat, lunge, stepping, running in place and jumping. The primary outcome measures of the study are the evaluation of fatigue (VAS) and functional capacity (6-Minute Walking Test). Our secondary outcome measures are the evaluation of pain, balance, physical fitness and walking. For the assessment of fatigue: Visual Analog Scale (VAS), PedsQL Multidimensional Fatigue Scale, Fatigue Severity Scale; For the assessment of functional capacity: 6 Minute Walk Test, 30 sec Sit-to-Stand Test, 10-Step Climbing Test, Pacer aebonic fitness test, Half Squat Test; For the assessment of balance: One-Leg Stand Test, Functional Forward Reach Test, Kinvent (K-plate)-K Force measurement evaluation set, Digitsole Smart Insole System for the assessment of walking; For the assessment of physical fitness: FitnessGram test battery; For the assessment of pain: VAS will be used.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • İstanbul University-Cerrahpaşa
        • Contact:
          • Istanbul University-Cerrahpasa Istanbul University-Cerrahpasa
          • Phone Number: (0212) 404 03 00

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 12-18
  • The parent's willingness to have their child participate in the study
  • Being diagnosed with FMF at least 6 months ago
  • Being in an attack-free period
  • Have an internet access
  • Being able to use a computer, tablet or smartphone
  • Have access to a technological device with a camera, microphone and speaker output
  • Being willing to participate in the study

Exclusion Criteria:

  • Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise
  • Acute pain for any reason
  • Development of amyloidosis

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: synchronous telerehabilitation group
Synchronous telerehabilitation group will be applied a synchronous supervised online exercise program under the supervision of a physiotherapist
Behavioral: Synchronous exercise program
The synchronous exercise group will be conducted online with synchronous supervision under the supervision of a physiotherapist. The exercise program will be performed for 8 weeks, 2 days a week. In the exercise program, 3 sets, 8 repetitions in 1 set will be progressed to 10-12-15-20-25 repetitions according to tolerance. There will be a 1-2 minute rest between sets.
Experimental: Asynchronous telerehabilitation group
Asynchronous telerehabilitation group will be applied an asynchronous video-based exercise program.
Behavioral: Asynchronous exercise group
The Asynchronous Exercise Group will be conducted with a video-based structured exercise program. For the asynchronous video-based group, a closed channel will be created on Youtube that only patients can access, and the exercises will be uploaded to the system asynchronously. In the asynchronous exercise group, how each exercise is performed will be shown in detail by the physiotherapist in the video content.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visuel Analog Scale
Time Frame: From enrollment to the end of treatment at 8 weeks"
In the evaluation of patient fatigue, patients will be asked to mark on a 100 mm horizontal line. According to VAS, a 0 mm point on this line indicates no fatigue, while a 100 mm point indicates very severe fatigue.
From enrollment to the end of treatment at 8 weeks"
Six Minute Walking Test
Time Frame: From enrollment to the end of treatment at 8 weeks
It is a test frequently used to evaluate functional capacity. The distance that patients walk in a 30-meter corridor on a flat surface for 6 minutes will be recorded.
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PedsQL Multidimensional Fatigue Scale
Time Frame: From enrollment to the end of treatment at 8 weeks
It is a measurement method consisting of 18 questions developed to evaluate fatigue in pediatric patients.
From enrollment to the end of treatment at 8 weeks
Fatigue Severity Scale
Time Frame: From enrollment to the end of treatment at 8 weeks
It is a tool consisting of 9 questions that evaluates fatigue severity.
From enrollment to the end of treatment at 8 weeks
30 Second Sit-to-Stand Test
Time Frame: From enrollment to the end of treatment at 8 weeks
One of the tests that will be used to test the functional capacity of individuals is the 30-second sit-to-stand test. During the test, patients will be asked to sit with their hands crossed over their shoulders and their feet touching the ground, and to do a full sit-to-stand in this position. The number of correct standing ups within thirty seconds will be recorded as the test score.
From enrollment to the end of treatment at 8 weeks
10-Step Climbing Test
Time Frame: From enrollment to the end of treatment at 8 weeks
In order to evaluate the functional capacity of the patients, they will be asked to quickly climb up and down 10 stairs and the test score will be recorded in seconds.
From enrollment to the end of treatment at 8 weeks
Half Squat Test
Time Frame: From enrollment to the end of treatment at 8 weeks
Individuals will be asked to maintain a half squat position on a hard surface, feet shoulder-width apart, hands crossed over shoulders, without shoes, in order to assess their functional capacity. The duration of the squat will be recorded in seconds.
From enrollment to the end of treatment at 8 weeks
Pacer Run Test
Time Frame: From enrollment to the end of treatment at 8 weeks
They will be asked to run between two cones in a 20-meter corridor, paying attention to the beeps coming from the voice recorder. The test will start at a slow running speed, and the speed will gradually increase every minute. If individuals cannot reach the cone line the first time when the beep sounds, they will be asked to run in the opposite direction. At the end of the test, the total number of completed laps will be taken as the score, including the laps that were not completed.
From enrollment to the end of treatment at 8 weeks
Single Leg Stand Test
Time Frame: From enrollment to the end of treatment at 8 weeks
In order to assess the balance of the subjects, they will be asked to stand on one leg with their hands crossed on their chest and the knee joint flexed at 90 degrees. It will be repeated for both the right and left extremities. The test score will be recorded in seconds.
From enrollment to the end of treatment at 8 weeks
Functional Forward Reach Test
Time Frame: From enrollment to the end of treatment at 8 weeks
Individuals will be asked to turn sideways to the wall, flex their arm 90 degrees from the shoulder, and make a fist. The third metacarpophalangeal joint will be marked as the starting point and individuals will be asked to reach forward as much as possible without taking a step or bending their knees. The third metacarpophalangeal joint alignment will be marked again at the last point reached. The distance between the two marked points will be recorded in centimeters.
From enrollment to the end of treatment at 8 weeks
K- Force-Kinvent Measurement and Evaluation Set
Time Frame: From enrollment to the end of treatment at 8 weeks
Balance skills will be tested during postures such as squat posture on K-Force plates, single leg and double leg postures with eyes open and closed.
From enrollment to the end of treatment at 8 weeks
Digitsole Pro Smart Insole System
Time Frame: From enrollment to the end of treatment at 8 weeks
The walking parameters of individuals will be evaluated with the Digitsole Smart Insole system. Digitsole Pro® smart insole is a valid and reliable measurement tool that allows the individual to evaluate the walking parameters of the individual by being placed inside the shoe worn by the participant. Individuals will be asked to walk wearing smart insoles with sensors inside their shoes. The spatio-temporal and kinematic walking parameters of individuals will be evaluated with the Digitsole Pro system.
From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery- Sit-up test
Time Frame: From enrollment to the end of treatment at 8 weeks
The FitnessGram test battery is a valid and reliable measurement method. Its components include functional capacity, flexibility, muscle strength, body composition and muscular endurance. The FitnessGram test battery will include the Sit-up test, Push-up test, Sit-and-reach test, Trunk lift test and Pacer test. The sit-up test will begin with the patient in a supine position with the knees flexed approximately 140 degrees and the knees slightly apart. The patient will be asked to do sit-ups in accordance with the commands from the voice recorder while the arms are extended next to the body, with the shoulder blades slightly lifted off the ground. The number of sit-ups will be recorded.
From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery-The push-up test
Time Frame: From enrollment to the end of treatment at 8 weeks
The push-up test, individuals will be asked to do push-ups in accordance with the commands from the device with the help of elbow flexion and extension while in the prone position. The number of push-ups done correctly will be recorded. The push-up test provides information about the endurance of the upper extremity muscles.
From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery-The Sit-Reach test
Time Frame: From enrollment to the end of treatment at 8 weeks
The Sit-Reach test: A plate with a length of 50 cm and a width of 45 cm is placed on a box with a length of 35 cm, a width of 45 cm and a height of 32 cm. During the test, individuals will reach forward with their hands as far as they can, with one knee in extension and the other knee in flexion in front of the test box. The evaluation will be repeated for the other side. At the end of the test, the distance the individual reaches will be recorded in cm
From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery-The trunk lift test
Time Frame: From enrollment to the end of treatment at 8 weeks
The trunk lift test will be performed to evaluate trunk extensor muscle endurance. The test will begin with the individual's hands placed under the thighs in a prone position on a flat surface. The subjects will be asked to slowly lift their trunks upwards with their heads. At the end of the test, the distance between the ground and the subjects' chin will be recorded in cm.
From enrollment to the end of treatment at 8 weeks
FitnessGram Test Battery- body composition
Time Frame: From enrollment to the end of treatment at 8 weeks
Body mass index will be calculated for body composition.
From enrollment to the end of treatment at 8 weeks
Visuel Analog Scale
Time Frame: From enrollment to the end of treatment at 8 weeks
Patients will be asked to mark their pain level on a 100 mm line. 0 mm on the line represents "no pain" and 100 mm represents "very severe pain."
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANamli

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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