Telerehabilitation in Patients With Osteoarthritis

Osteoarthritis Clinical Trial

— TABLET  

Official title:

Effectiveness of Telerehabilitation in Patients With Osteoarthritis. A Randomized Controlled

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05719350
• Other study ID #: 0001333
• Status: Completed
• Phase: N/A
• Start date: February 8, 2023
• Est. completion date: September 24, 2023

Study information

• Verified date: September 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 24, 2023
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects must have a diagnosis of rheumatologic disease, osteoarthritis of one or more articulations, OARSI criteria.

• Male or Female, aged > 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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	Roberto Tedeschi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating of Pain	rating of pain in the knee joint with osteoarthritis measured with the nprs pain scale	one Month
Secondary	Quality of life improvement	Improved quality of life as measured by the Short Form Health Survey scale	one month, three month
Secondary	Assessment of knee joint function	Assessment of knee joint function as measured by the Womac scale	one month, three month