Efficacy of STABL Virtual Rehabilitation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Patients undergoing minor knee procedures (defined as meniscectomy and synovectomy) will be randomized to virtual rehabilitation using the STABL platform or standard physical therapy over the course of 6 weeks to determine any possible difference in clinical outcomes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rehabilitation using STABL platform Patients undergoing minor knee procedures (defined as meniscectomy and synovectomy) will be randomized to virtual rehabilitation using the STABL platform |
Behavioral: STABL Virtual Rehabilitation
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.
|
| No Intervention: Rehabilitation using standard physical therapy Patients undergoing minor knee procedures (defined as meniscectomy and synovectomy) will be randomized to standard physical therapy. |
Outcome Measures
Primary Outcome Measures
- Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale [Baseline, Week 3]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale [Baseline, Month 6]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale [Baseline, Month 12]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale [Baseline, Week 3]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale [Baseline, Month 6]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale [Baseline, Month 12]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale [Baseline, Week 3]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale [Baseline, Month 6]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale [Baseline, Month 12]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale [Baseline, Week 3]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale [Baseline, Month 6]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale [Baseline, Month 12]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale [Baseline, Week 3]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale [Baseline, Month 6]
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.
- Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale [Baseline, , Month 12]
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.
- Change in Visual Analogue Scale (VAS) Pain score [Baseline, Week 3]
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.
- Change in Visual Analogue Scale (VAS) Pain score [Baseline, Month 6]
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.
- Change in Visual Analogue Scale (VAS) Pain score [Baseline, Month 12]
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.
- Change in Active Range of Motion (AROM) [Baseline, Week 1]
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).
- Change in Active Range of Motion (AROM) [Baseline, Week 3]
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).
- Change in Active Range of Motion (AROM) [Baseline, Month 6]
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).
- Change in Active Range of Motion (AROM) [Baseline, Month 12]
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).
- Change in Passive Range of Motion (PROM) [Baseline, Week 1]
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).
- Change in Passive Range of Motion (PROM) [Baseline, Week 4-6]
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).
- Change in Passive Range of Motion (PROM) [Baseline, Month 6]
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).
- Change in Passive Range of Motion (PROM) [Baseline, Month 12]
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).
- Change in ACL-Return to Sport (ACL-RSI) Scale Score [Baseline, Week 3]
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%).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Underwent meniscectomy or synovectomy surgery
-
Age 18-65
-
Ability to comply with a standardized postoperative protocol
-
Willing and able to provide consent
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Guillem Gonzalez-Lomas, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-00951