Telerehabilitation in Patients With Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: Exercises for Knee

• Registration Number: NCT05719350
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study Start: 2023-02-08
• Study First Posted: 2023-02-08
• Status Verified: 2023-09
• Primary Completion: 2023-09-24
• Study Completion: 2023-09-24
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Exercises for Knee	Tele-rehabilitation exercises for the knee joint to reduce pain
Control Group	Exercises for Knee	Exercises in presence for the knee joint to decrease pain

Primary Outcome Measures

Name	Time	Method
Rating of Pain	one Month	rating of pain in the knee joint with osteoarthritis measured with the nprs pain scale

Secondary Outcome Measures

Name	Time	Method
Quality of life improvement	one month, three month	Improved quality of life as measured by the Short Form Health Survey scale
Assessment of knee joint function	one month, three month	Assessment of knee joint function as measured by the Womac scale

Trial Locations

Locations (1)

Roberto Tedeschi; 🇮🇹 Bologna, Italy