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Clinical Trials/NCT05719350
NCT05719350
Completed
N/A

Effectiveness of Telerehabilitation in Patients With Osteoarthritis. A Randomized Controlled

Istituto Ortopedico Rizzoli1 site in 1 country50 target enrollmentFebruary 8, 2023
ConditionsOsteoarthritis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
50
Locations
1
Primary Endpoint
Rating of Pain
Status
Completed
Last Updated
2 years ago

Overview

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

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

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

  7. 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.

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

Registry
clinicaltrials.gov
Start Date
February 8, 2023
End Date
September 24, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Rating of Pain

Time Frame: one Month

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

Secondary Outcomes

  • Quality of life improvement(one month, three month)
  • Assessment of knee joint function(one month, three month)

Study Sites (1)

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