Telerehabilitation in Patients With Osteoarthritis

NCT ID: NCT05719350

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2023-09-24

Brief Summary

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Randomized controlled study on the effectiveness of Telerehabilitation intervention on subjects with knee osteoarthritis. Subjects will be randomized into two groups. The experimental group perform 3 sessions a week for 4 weeks of TR, the control group 3 sessions a week for 4 weeks of conventional rehabilitation c/o IOR rehabilitation gym. Follow-up at 3 months.

Inclusion criteria

1. Subjects must have a diagnosis of rheumatologic disease, osteoarthritis of one or more indications, OARSI criteria.
2. Male or Female, aged \> 18 years
3. Participant is willing and able to provide informed consent for participation in the study.
4. Subjects must be able to use an electronic device (pc, tablet, smartphone). Exclusion criteria

1\. Participation in another clinical study with any investigational agent within 30 days prior of the study screening.

2\. Inability to use an electronic device (pc, tablet, smartphone) 4. Diagnosed with dementia or neurological disease that impairs speech comprehension e Not verbal.

5\. Uncontrolled intercurrent illnesses including, without limitation, current infection or active, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illnesses/social situations that would limit compliance with study requirements, illnesses neurological.

6\. Children under the age of 18 8. NPRS value \<3 7. BMI \>25

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group

Tele-rehabilitation exercises for the knee joint to reduce pain

Group Type EXPERIMENTAL

Exercises for Knee

Intervention Type OTHER

Four exercises for strengthening and mobility of the knee joint two in a sitting position and two in a standing position for a total of 20-25 minutes

Control Group

Exercises in presence for the knee joint to decrease pain

Group Type ACTIVE_COMPARATOR

Exercises for Knee

Intervention Type OTHER

Four exercises for strengthening and mobility of the knee joint two in a sitting position and two in a standing position for a total of 20-25 minutes

Interventions

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Exercises for Knee

Four exercises for strengthening and mobility of the knee joint two in a sitting position and two in a standing position for a total of 20-25 minutes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects must have a diagnosis of rheumatologic disease, osteoarthritis of one or more articulations, OARSI criteria.
* Male or Female, aged \&gt; 18 years
* Participant is willing and able to provide informed consent for participation in the
* study.
* Subjects must be able to use

Exclusion Criteria

* Participation in another clinical study with any investigational agent within 30 days prior
* of the study screening.
* Inability to use an electronic device (pc, tablet, smartphone)
* Diagnosed with dementia or neurological disease that impairs speech comprehension e Not verbal.
* Uncontrolled intercurrent illnesses including, without limitation, current infection or active, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illnesses/social situations that would limit compliance with study requirements, illnesses neurological.
* hildren under the age of 18
* Numeric Pain Rating Scale(NPRS) value \<3
* BMI \>25
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Grazia Benedetti, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

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Roberto Tedeschi

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0001333

Identifier Type: -

Identifier Source: org_study_id

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