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Behavioural Intervention

Technology-implemented exercise therapy for Osteoarthritis

N/A

Recruiting

Led By Laura Tabacof

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic OA (National Institute for Health and Care Excellence clinical criteria for OA)

KL Stages 1-2-3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will test if home exercise with SimpleTherapy can help people with knee OA as much as physical therapy.

Who is the study for?

This trial is for adults over 18 living in CT/NY/NJ with knee pain from osteoarthritis, who've had this pain for more than 3 months and have an average pain score of at least 4 out of 11. They must have internet access and be in the early to moderate stages of OA. People with cognitive impairments, recent surgeries or falls, severe heart disease, bleeding disorders, or those already doing physical therapy can't join.Check my eligibility

What is being tested?

The study compares two ways to treat knee pain due to osteoarthritis: traditional physical therapy versus a home-based exercise program called SimpleTherapy. Participants will follow their assigned treatment three times a week for six weeks to see if the remote exercise is as effective as regular physical therapy.See study design

What are the potential side effects?

Since this trial involves non-drug therapies (physical exercises), side effects may include muscle soreness, joint discomfort or fatigue related to exercise. Serious side effects are unlikely but could involve injury if exercises are not performed correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have painful osteoarthritis according to official health guidelines.

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My knee arthritis is mild to moderate.

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I have had knee pain for more than 3 months.

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My average pain level is 4 or higher on a scale of 0 to 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Secondary outcome measures

Brief Pain Inventory

Brief Pain Inventory - short form (BPI-SF)

Difficulty of exercises (PT arm)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Technology-implemented exercise therapyExperimental Treatment1 Intervention

Therapy plans performed at home overseen by a remote physical therapist via SimpleTherapy. Allocation to this group will require using smart devices or a computer/laptop to receive care. Remote visits with a PT typically last 45min long and home exercises suggested by the app are self-paced.

Group II: Traditional Physical TherapyActive Control1 Intervention

Participants will be prescribed an exercise plan by a physical therapist as normally would occur as part of standards of care outside the context of a research study. In-person assessments and at-home exercise suggestions will be decided by the physical therapist. Duration of PT appointments is typically 45 minutes long two times per week and are supplemented by PT recommended self-paced at-home exercises.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,406 Total Patients Enrolled

2 Trials studying Osteoarthritis

99 Patients Enrolled for Osteoarthritis

Laura TabacofPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in the experiment?

"Yes, the information hosted on clinicaltrials.gov demonstrates that this trial is currently enrolling individuals. It was initially listed on December 1st 2023 and has since been updated as recently as December 4th of the same year; 220 participants need to be recruited from one medical facility."

Answered by AI

Are participants currently being admitted to this trial?

"Yes, according to the information on clinicaltrials.gov this trial is currently enrolling patients. The research was first made accessible on December 1st 2023 and has been recently modified as of December 4th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Physical Therapy vs Remote Exercise for Knee Pain Due to Osteoarthritis (OA)

Laura Tabacof 2024. "Physical Therapy vs Remote Exercise for Knee Pain Due to Osteoarthritis (OA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06167304.

All > Knee Pain