Telerehabilitation in Patients With Osteoarthritis

NCT05719350 | Completed

• 1 other identifier: 0001333
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Rating of Pain

  rating of pain in the knee joint with osteoarthritis measured with the nprs pain scale

  one Month

Secondary Outcomes (2)

• Quality of life improvement

  one month, three month

• Assessment of knee joint function

  one month, three month

Study Arms (2)

Experimental Group

EXPERIMENTAL

Tele-rehabilitation exercises for the knee joint to reduce pain

Other: Exercises for Knee

Control Group

ACTIVE COMPARATOR

Exercises in presence for the knee joint to decrease pain

Other: Exercises for Knee

Interventions

Exercises for Knee 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; Experimental Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Roberto Tedeschi

Bologna, 40141, Italy

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maria Grazia Benedetti, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: February 8, 2023
• Primary Completion: September 24, 2023
• Study Completion: September 24, 2023
• Last Updated: April 3, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)