Knee OsteoarthritisNCT06167304
Physical Therapy vs Remote Exercise for Knee Pain Due to Osteoarthritis (OA)
A study testing Technology-implemented exercise therapy and Traditional Physical Therapy in people with Knee Osteoarthritis and Chronic Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this clinical study is to demonstrate that after six weeks of at home exercise, 3 times per week with SimpleTherapy, participants with clinical indications of knee OA will on average have improved outcomes noninferior than traditionally prescribed physical therapy regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Chronic Pain
- What is being tested?
- Technology-implemented exercise therapy and Traditional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 12 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age ≥ 18 years)
- Living in the tristate area - CT/NY/NJ
- Symptomatic OA (National Institute for Health and Care Excellence clinical criteria for OA)
- Chronic knee pain (>3 months) as a primary pain complaint
- Average pain score ≥ 4 on an 11-point numeric rating scale at baseline
- Access to a device with internet connection
- KL Stages 1-2-3
Who cannot join
- Prior documented history of cognitive impairment;
- History of total knee arthroplasty;
- History of: Inflammatory arthritis (e.g. rheumatoid arthritis); or any neuropathies affecting the lower limbs, spinal cord injury, spine fractures, advanced heart disease, bleeding issues (i.e. hemophilia), surgery within the last 90 days; fall within 90 days; high risk of fracture;
- History of knee injury, within the last 3 months;
- Currently engaged with other PT or strengthening program;
- Present unstable/uncontrolled cardiovascular condition
- Undergoing active chemotherapy for cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Home Exercise Program Versus Standard of Care for Chronic OA-related Knee Pain: a Non-inferiority Randomized Controlled Trial
The purpose of this clinical study is to demonstrate that after six weeks of at home exercise, 3 times per week with SimpleTherapy, participants with clinical indications of knee OA will on average have improved outcomes noninferior than traditionally prescribed physical therapy regimens.
- Conditions
- Knee Osteoarthritis, Chronic Pain
- Being tested
- Technology-implemented exercise therapy, Traditional Physical Therapy
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-implemented exercise therapyOther
Therapy plans are performed at home overseen by a remote physical therapist via SimpleTherapy.
Traditional Physical TherapyOther
Traditional physical therapy per Standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Technology-implemented exercise therapy | Experimental | 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. Receives: Other: Technology-implemented exercise therapy |
| Traditional Physical Therapy | Active comparator | 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. Receives: Other: Traditional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, activities of daily living (ADLs), sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.
Measured: Baseline Week 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, ADLs, sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.
Measured: Baseline Week 2
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, ADLs, sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.
Measured: 12 weeks
Secondary outcomes (25)
Brief Pain Inventory - short form (BPI-SF)
The BPI -SF rates severity pain and the degree to which pain interferes with common dimensions of feeling and function. It includes 9 items (0-No pain to 10-Pain as bad as you can imagine) and results in two scores ranging between 0-10: Pain Intensity and Pain Interference, with higher score indicating worse outcomes.
Measured: Baseline Week 0
Brief Pain Inventory
The BPI -SF rates severity pain and the degree to which pain interferes with common dimensions of feeling and function. It includes 9 items (0-No pain to 10-Pain as bad as you can imagine) and results in two scores ranging between 0-10: Pain Intensity and Pain Interference, with higher score indicating worse outcomes.
Measured: Baseline Week 2
Brief Pain Inventory
The BPI -SF rates severity pain and the degree to which pain interferes with common dimensions of feeling and function. It includes 9 items (0-No pain to 10-Pain as bad as you can imagine) and results in two scores ranging between 0-10: Pain Intensity and Pain Interference, with higher score indicating worse outcomes.
Measured: 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)
Measures are based on "item banks," sets of items that represent symptom or functional domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The T-score is provided with an error term (Standard Error or SE, 95% confidence interval).
Measured: Baseline Week 0
Patient Reported Outcomes Measurement Information System (PROMIS)
Measures are based on "item banks," sets of items that represent symptom or functional domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The T-score is provided with an error term (Standard Error or SE, 95% confidence interval).
Measured: Baseline Week 2
Patient Reported Outcomes Measurement Information System (PROMIS)
Measures are based on "item banks," sets of items that represent symptom or functional domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The T-score is provided with an error term (Standard Error or SE, 95% confidence interval).
Measured: 12 weeks
PSEQ-2 (Pain Self efficacy questionnaire-SF 2)
Assesses pain self-efficacy, which is a belief in one's ability to carry out activities even when in pain. The PSEQ-2 is a shorter version of PROMISE Self-Efficacy for Managing Chronic pain and it has been clinically validated. PSEQ-2 includes two items scored on a 7-point Likert scale (0- not at all confident to 6- Completely confident) which are added to form a total score ranging from 0 to 12. High scores indicate greater self-efficacy.
Measured: Baseline Week 0
PSEQ-2 (Pain Self efficacy questionnaire-SF 2)
Assesses pain self-efficacy, which is a belief in one's ability to carry out activities even when in pain. The PSEQ-2 is a shorter version of PROMISE Self-Efficacy for Managing Chronic pain and it has been clinically validated. PSEQ-2 includes two items scored on a 7-point Likert scale (0- not at all confident to 6- Completely confident) which are added to form a total score ranging from 0 to 12. High scores indicate greater self-efficacy.
Measured: Baseline Week 2
PSEQ-2 (Pain Self efficacy questionnaire-SF 2)
Assesses pain self-efficacy, which is a belief in one's ability to carry out activities even when in pain. The PSEQ-2 is a shorter version of PROMISE Self-Efficacy for Managing Chronic pain and it has been clinically validated. PSEQ-2 includes two items scored on a 7-point Likert scale (0- not at all confident to 6- Completely confident) which are added to form a total score ranging from 0 to 12. High scores indicate greater self-efficacy.
Measured: 12 weeks
Work Productivity and Activity Impairment (WPAI)
WPAI measures impairments in work and activities. The WPAI yields four types of scores:
- Absenteeism B. Presenteeism C. Work productivity loss (overall work impairment / absenteeism plus presenteeism; D. Activity Impairment
WPAI outcomes are expressed as impairment percentages (0%-100%), with higher numbers indicating greater impairment and less productivity (worse outcomes).
Measured: Baseline Week 0
Work Productivity and Activity Impairment (WPAI)
WPAI measures impairments in work and activities. The WPAI yields four types of scores:
- Absenteeism B. Presenteeism C. Work productivity loss (overall work impairment / absenteeism plus presenteeism; D. Activity Impairment
WPAI outcomes are expressed as impairment percentages (0%-100%), with higher numbers indicating greater impairment and less productivity (worse outcomes).
Measured: Baseline Week 2
Work Productivity and Activity Impairment (WPAI)
WPAI measures impairments in work and activities. The WPAI yields four types of scores:
- Absenteeism B. Presenteeism C. Work productivity loss (overall work impairment / absenteeism plus presenteeism; D. Activity Impairment
WPAI outcomes are expressed as impairment percentages (0%-100%), with higher numbers indicating greater impairment and less productivity (worse outcomes).
Measured: 12 weeks
PGI-C (Patient global impression of change)
Captures perception of change in activity, limitations, feelings, emotions and health related QOL related to pain. PGIC is a 7 point scale depicting a patient's overall improvement rating. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." Measure correlations of patient ratings of importance of change with the magnitude of that change. The PGI-I is a transition scale that is a single question asking the patient to rate their condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.
Measured: Baseline Week 0
PGI-C (Patient global impression of change)
Captures perception of change in activity, limitations, feelings, emotions and health related QOL related to pain. PGIC is a 7 point scale depicting a patient's overall improvement rating. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." Measure correlations of patient ratings of importance of change with the magnitude of that change. The PGI-I is a transition scale that is a single question asking the patient to rate their condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.
Measured: Baseline Week 2
PGI-C (Patient global impression of change)
Captures perception of change in activity, limitations, feelings, emotions and health related QOL related to pain. PGIC is a 7 point scale depicting a patient's overall improvement rating. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." Measure correlations of patient ratings of importance of change with the magnitude of that change. The PGI-I is a transition scale that is a single question asking the patient to rate their condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.
Measured: 12 weeks
Tampa Kinesiophobia Scale (TSK)
TSK is a self-reported questionnaire that quantifies fear of movement, or (re)injury. Individual item scores range from 1-4, with the negatively worded items having a reverse scoring. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Measured: Baseline Week 0
Tampa Kinesiophobia Scale
TSK is a self-reported questionnaire that quantifies fear of movement, or (re)injury. Individual item scores range from 1-4, with the negatively worded items having a reverse scoring. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Measured: Baseline Week 2
Tampa Kinesiophobia Scale
TSK is a self-reported questionnaire that quantifies fear of movement, or (re)injury. Individual item scores range from 1-4, with the negatively worded items having a reverse scoring. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Measured: 12 weeks
Pain Catastrophizing Scale
13-item self reported measure designed to assess catastrophic thinking related to pain among adults. Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: Baseline Week 0
Pain Catastrophizing Scale
13-item self reported measure designed to assess catastrophic thinking related to pain among adults. Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: Baseline Week 2
Pain Catastrophizing Scale
13-item self reported measure designed to assess catastrophic thinking related to pain among adults. Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: 12 weeks
Subjective questionnaire (ST arm)
6-item questionnaire (yes/no) assessing accessibility, satisfaction with care and pain management, enjoyment, referral to friends or colleagues, and one open answer on recommendations for the exercise intervention.
Measured: 12 weeks
Medication (PT arm)
Questionnaire asking Yes/No for starting new prescribed medication or treatment (if yes, name of new medication/treatment is requested).
Measured: 12 weeks
Difficulty of exercises (PT arm)
Questionnaire tracking difficulty of exercises (0-not difficult at all, to 10- Extremely Difficult), total score ranges 0-10, with higher scores indicating greater difficulty.
Measured: 12 weeks
Number of exercises completed (PT arm)
Questionnaire tracking home exercise adherence (How many Exercises this week?).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start29 Jan 2024
- Primary completion29 Jan 2024
- Study completion12 Feb 2025
Why it stopped: Sponsor halted funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Putrino, Icahn School of Medicine at Mount Sinai
- Investigators
- David Putrino, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167304
- Sponsor's protocol ID
- STUDY-22-01430
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only sharing analyzed deidentified information, not individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Home Exercise Program Versus Standard of Care for Chronic OA-related Knee Pain: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06167304
- Acronym / sponsor ID
- STUDY-22-01430
- Conditions
- Knee Osteoarthritis, Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor halted funding
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to demonstrate that after six weeks of at home exercise, 3 times per week with SimpleTherapy, participants with clinical indications of knee OA will on average have improved outcomes noninferior than traditionally prescribed physical therapy regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-implemented exercise therapy | Experimental | Other: Technology-implemented exercise therapyTherapy 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. |
| Traditional Physical Therapy | Active comparator | Other: Traditional Physical TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (age ≥ 18 years)
- Living in the tristate area - CT/NY/NJ
- Symptomatic OA (National Institute for Health and Care Excellence clinical criteria for OA)
- Chronic knee pain (>3 months) as a primary pain complaint
- Average pain score ≥ 4 on an 11-point numeric rating scale at baseline
Key exclusion criteria (7 listed)
- Prior documented history of cognitive impairment;
- History of total knee arthroplasty;
- History of: Inflammatory arthritis (e.g. rheumatoid arthritis); or any neuropathies affecting the lower limbs, spinal cord injury, spine fractures, advanced heart disease, bleeding issues (i.e. hemophilia), surgery within the last 90 days; fall within 90 days; high risk of fracture;
- History of knee injury, within the last 3 months;
- Currently engaged with other PT or strengthening program;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-implemented exercise therapyTherapy plans are performed at home overseen by a remote physical therapist via SimpleTherapy. | Other | Technology-implemented exercise therapy |
| Traditional Physical TherapyTraditional physical therapy per Standard of care. | Other | Traditional Physical Therapy |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline Week 0
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, activities of daily living (ADLs), sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline Week 2
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, ADLs, sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, ADLs, sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.
25 secondary outcomes
Brief Pain Inventory - short form (BPI-SF)
Time frame: Baseline Week 0
Brief Pain Inventory
Time frame: Baseline Week 2
Brief Pain Inventory
Time frame: 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline Week 0
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline Week 2
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: 12 weeks
PSEQ-2 (Pain Self efficacy questionnaire-SF 2)
Time frame: Baseline Week 0
PSEQ-2 (Pain Self efficacy questionnaire-SF 2)
Time frame: Baseline Week 2
PSEQ-2 (Pain Self efficacy questionnaire-SF 2)
Time frame: 12 weeks
Work Productivity and Activity Impairment (WPAI)
Time frame: Baseline Week 0
Work Productivity and Activity Impairment (WPAI)
Time frame: Baseline Week 2
Work Productivity and Activity Impairment (WPAI)
Time frame: 12 weeks
PGI-C (Patient global impression of change)
Time frame: Baseline Week 0
PGI-C (Patient global impression of change)
Time frame: Baseline Week 2
PGI-C (Patient global impression of change)
Time frame: 12 weeks
Tampa Kinesiophobia Scale (TSK)
Time frame: Baseline Week 0
Tampa Kinesiophobia Scale
Time frame: Baseline Week 2
Tampa Kinesiophobia Scale
Time frame: 12 weeks
Pain Catastrophizing Scale
Time frame: Baseline Week 0
Pain Catastrophizing Scale
Time frame: Baseline Week 2
Pain Catastrophizing Scale
Time frame: 12 weeks
Subjective questionnaire (ST arm)
Time frame: 12 weeks
Medication (PT arm)
Time frame: 12 weeks
Difficulty of exercises (PT arm)
Time frame: 12 weeks
Number of exercises completed (PT arm)
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Sponsor halted funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No. Only sharing analyzed deidentified information, not individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Putrino principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-implemented exercise therapy and Traditional Physical Therapy in people with Knee Osteoarthritis and Chronic Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor halted funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Baseline Week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.