Telerehabilitation in Patients With Osteoarthritis (TABLET)
Effectiveness of Telerehabilitation in Patients With Osteoarthritis. A Randomized Controlled
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
- Subjects must have a diagnosis of rheumatologic disease, osteoarthritis of one or more indications, 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 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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bologna, Italy, 40141
- Roberto Tedeschi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Tele-rehabilitation exercises for the knee joint to reduce pain
|
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
|
|
Active Comparator: Control Group
Exercises in presence for the knee joint to decrease pain
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rating of Pain
Time Frame: one Month
|
rating of pain in the knee joint with osteoarthritis measured with the nprs pain scale
|
one Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life improvement
Time Frame: one month, three month
|
Improved quality of life as measured by the Short Form Health Survey scale
|
one month, three month
|
|
Assessment of knee joint function
Time Frame: one month, three month
|
Assessment of knee joint function as measured by the Womac scale
|
one month, three month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Grazia Benedetti, MD, Istituto Ortopedico Rizzoli
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001333
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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