Telerehabilitation in Patients With Osteoarthritis | NCT05719350

Studies
Telerehabilitation in Patients With Osteoarthritis

NCT05719350

Sponsor

Istituto Ortopedico Rizzoli

Status

Completed

Last Update Posted

Apr 3, 2024Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

Exercises for Knee

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2023Actual

Primary Completion Date

Sep 24, 2023Actual

Completion Date

Sep 24, 2023Actual

First Submitted Date

Jan 30, 2023

First Submission Date that Met QC Criteria

Jan 30, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2024

Last Update Posted Date

Apr 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rating of Pain	rating of pain in the knee joint with osteoarthritis measured with the nprs pain scale	one Month

Secondary Outcomes

Measure	Description	Time Frame
Quality of life improvement	Improved quality of life as measured by the Short Form Health Survey scale	one month, three month
Assessment of knee joint function	Assessment of knee joint function as measured by the Womac scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Grazia Benedetti, MD	Istituto Ortopedico Rizzoli	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Roberto Tedeschi		Bologna		40141	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided