A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement

June 29, 2022 updated by: Derek Amanatullah
This is the research study of a rehabilitation tool that informs, guides and empowers clinicians to care for their patients. We hope to learn ways to improve patient outcomes, reduce costs and increase value to the healthcare system

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. Rehab tool will optimize care according to the patient's specific needs and provided insights to patients length of stay in the hospital. these data driven insights will be used to observe correlation between machine and clinic data

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Stanford outpatient center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient scheduled for Primary unilateral total joint replacement
  • Patient age should be more than or equal to 18 years.
  • Patient must speak English

Exclusion Criteria:

  • Patients undergoing bilateral primary knee replacement surgery
  • Patients undergoing revision knee replacement surgery
  • No uncorrectable deformity
  • No deformity greater than 15 degree
  • No hip arthritis
  • No wheelchair dependency
  • Patients not willing and capable to sign the written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
The application used is build upon the company's category-defining, FDA- cleared Virtual Exercise Rehabilitation Assistant (VERA™) and create a platform that streamlines the performance and management of post-acute care physical therapy. The rehab tool will provide us with functional outcome score.
Device: VERA clinic
A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic and at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of Stay in Hospital Through Discharge
Time Frame: Up to 2 days
Up to 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Requiring Gait Aid Use
Time Frame: 3 months post operative visit
The gait aide use ranges in the order of decreasing performance as Nothing > Cane > crutch > walker.
3 months post operative visit
Knee Society Score (KSS)
Time Frame: 3 months post operative visit
To assess the effectiveness of the device by calculating knee society score (KSS) after surgery. The scale ranges from 0-100 with grading as Score 80-100 - Excellent Score 70-79 - Good Score 60-69 - Fair Score below 60 - Poor
3 months post operative visit
Knee Range of Motion
Time Frame: 3 months post operative visit
To assess the effectiveness of the device by calculating range of motion (maximum degrees)
3 months post operative visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derek Amanatullah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

March 10, 2020

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 14, 2018

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 46061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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