Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-25 @ 2:47 PM
Study NCT ID:
NCT05719350
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2023-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telerehabilitation in Patients With Osteoarthritis
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Study Overview
Official Title:
Effectiveness of Telerehabilitation in Patients With Osteoarthritis. A Randomized Controlled
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TABLET
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: