Efficacy of STABL Virtual Rehabilitation

NCT05556850 | Completed

• 1 other identifier: 22-00951
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed study is to evaluate the efficacy of STABL rehabilitation vs in-person rehabilitation following meniscectomy or synovectomy. STABL is a digital health platform that uses computer-vision technology to facilitate at-home post-op recovery for patients while enabling remote monitoring by their surgeon.

Conditions

Physical Therapy

Outcome Measures

Primary Outcomes (27)

• Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale

  Measured by the Pain Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Week 3

• Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale

  Measured by the Pain Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Month 6

• Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale

  Measured by the Pain Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Month 12

• Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale

  Measured by the Symptoms Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Week 3

• Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale

  Measured by the Symptoms Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Month 6

• Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale

  Measured by the Symptoms Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Month 12

• Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale

  Measured by the function/sports and recreational activities Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Week 3

• Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale

  Measured by the function/sports and recreational activities Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Month 6

• Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale

  Measured by the function/sports and recreational activities Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Month 12

• Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale

  Measured by the Quality of life Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Week 3

• Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale

  Measured by the Quality of life Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Month 6

• Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale

  Measured by the Quality of life Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Month 12

• Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale

  Measured by the function/daily living Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Week 3

• Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale

  Measured by the function/daily living Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, Month 6

• Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale

  Measured by the function/daily living Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

  Baseline, , Month 12

• Change in Visual Analogue Scale (VAS) Pain score

  VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

  Baseline, Week 3

• Change in Visual Analogue Scale (VAS) Pain score

  VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

  Baseline, Month 6

• Change in Visual Analogue Scale (VAS) Pain score

  VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

  Baseline, Month 12

• Change in Active Range of Motion (AROM)

  AROM is measured using a goniometer (protractor that measures joint angles) to see how much the knee can bend and straighten on its own (without assistance). Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).

  Baseline, Week 1

• Change in Active Range of Motion (AROM)

  AROM is measured using a goniometer (protractor that measures joint angles) to see how much the knee can bend and straighten on its own (without assistance). Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).

  Baseline, Week 3

• Change in Active Range of Motion (AROM)

  AROM is measured using a goniometer (protractor that measures joint angles) to see how much the knee can bend and straighten on its own (without assistance). Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).

  Baseline, Month 6

• Change in Active Range of Motion (AROM)

  AROM is measured using a goniometer (protractor that measures joint angles) to see how much the knee can bend and straighten on its own (without assistance). Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).

  Baseline, Month 12

• Change in Passive Range of Motion (PROM)

  PROM is measured using a goniometer (protractor that measures joint angles) to see how far the knee can bend and straighten when moved by an external force. Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).

  Baseline, Week 1

• Change in Passive Range of Motion (PROM)

  PROM is measured using a goniometer (protractor that measures joint angles) to see how far the knee can bend and straighten when moved by an external force. Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).

  Baseline, Week 4-6

• Change in Passive Range of Motion (PROM)

  PROM is measured using a goniometer (protractor that measures joint angles) to see how far the knee can bend and straighten when moved by an external force. Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).

  Baseline, Month 6

• Change in Passive Range of Motion (PROM)

  PROM is measured using a goniometer (protractor that measures joint angles) to see how far the knee can bend and straighten when moved by an external force. Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).

  Baseline, Month 12

• Change in ACL-Return to Sport (ACL-RSI) Scale Score

  The ACL-RSI scale includes 12 questions on the patient's emotional well-being and confidence in his or her performance and risk appraisal. The scale, with scores ranging from 1 to 10, includes 5 questions on emotional well-being, 5 questions on confidence in physical performance, and 2 questions on the appraisal of risk. Higher scores indicate a more positive psychological response. The total score is determined by adding the values of the 12 responses and then calculating their relationship to 100 to obtain a percentage (0-100%).

  Baseline, Week 3

Study Arms (2)

Rehabilitation using STABL platform

EXPERIMENTAL

Patients undergoing minor knee procedures (defined as meniscectomy and synovectomy) will be randomized to virtual rehabilitation using the STABL platform

Behavioral: STABL Virtual Rehabilitation

Rehabilitation using standard physical therapy

NO INTERVENTION

Patients undergoing minor knee procedures (defined as meniscectomy and synovectomy) will be randomized to standard physical therapy.

Interventions

STABL Virtual Rehabilitation BEHAVIORAL

STABL is a digital health platform that uses computer-vision technology to facilitate at-home post-op recovery for patients while enabling remote monitoring by their surgeon. The platform is fully HIPAA compliant. STABL analyzes a patient's biomechanics in real time while they perform their recovery exercises to provide them with cues to ensure the exercises are done correctly and track adherence. They then relay all the data to the patient's clinician to allow them to monitor their recovery remotely, address any adherence barriers, and mitigate readmission risks that arise in a more timely manner.

Rehabilitation using STABL platform

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent meniscectomy or synovectomy surgery
• Age 18-65
• Ability to comply with a standardized postoperative protocol
• Willing and able to provide consent

You may not qualify if:

• Previous knee surgery
• Patients at any increased risk of falls or at increased risk from harm due to falling, including issues with vertigo, osteoporosis, or a history of past falls
• Patient otherwise deemed at increased risk from this investigational rehabilitation program by their referring surgeon or physical therapist
• Patients who are pregnant

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Guillem Gonzalez-Lomas

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: March 1, 2023
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request, Requests should be directed to Zachary.li@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)