Efficacy of STABL Virtual Rehabilitation

NCT ID: NCT05556850

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Physical Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rehabilitation using STABL platform

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

Group Type EXPERIMENTAL

STABL Virtual Rehabilitation

Intervention Type 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 standard physical therapy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillem Gonzalez-Lomas

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Zachary Li

Role: CONTACT

317-517-0426

Facility Contacts

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Zachary Li

Role: primary

317-517-0426

Other Identifiers

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22-00951

Identifier Type: -

Identifier Source: org_study_id

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