Clinical trial NCT05556850: Efficacy of STABL Virtual Rehabilitation
Official title: Efficacy of STABL Virtual Rehabilitation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale
timeFrame: Baseline, Week 3
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale
timeFrame: Baseline, Month 6
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale
timeFrame: Baseline, Month 12
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale
timeFrame: Baseline, Week 3
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale
timeFrame: Baseline, Month 6
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale
timeFrame: Baseline, Month 12
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale
timeFrame: Baseline, Week 3
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale
timeFrame: Baseline, Month 6
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale
timeFrame: Baseline, Month 12
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale
timeFrame: Baseline, Week 3
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale
timeFrame: Baseline, Month 6
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale
timeFrame: Baseline, Month 12
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale
timeFrame: Baseline, Week 3
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale
timeFrame: Baseline, Month 6
measure: Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale
timeFrame: Baseline, , Month 12
measure: Change in Visual Analogue Scale (VAS) Pain score
timeFrame: Baseline, Week 3
measure: Change in Visual Analogue Scale (VAS) Pain score
timeFrame: Baseline, Month 6
measure: Change in Visual Analogue Scale (VAS) Pain score
timeFrame: Baseline, Month 12
measure: Change in Active Range of Motion (AROM)
timeFrame: Baseline, Week 1
measure: Change in Active Range of Motion (AROM)
timeFrame: Baseline, Week 3
measure: Change in Active Range of Motion (AROM)
timeFrame: Baseline, Month 6
measure: Change in Active Range of Motion (AROM)
timeFrame: Baseline, Month 12
measure: Change in Passive Range of Motion (PROM)
timeFrame: Baseline, Week 1
measure: Change in Passive Range of Motion (PROM)
timeFrame: Baseline, Week 4-6
measure: Change in Passive Range of Motion (PROM)
timeFrame: Baseline, Month 6
measure: Change in Passive Range of Motion (PROM)
timeFrame: Baseline, Month 12
measure: Change in ACL-Return to Sport (ACL-RSI) Scale Score
timeFrame: Baseline, Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Guillem Gonzalez-Lomas
role: PRINCIPAL_INVESTIGATOR
References: