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

March 1, 2023 updated by: Derek Amanatullah
SPARTA force plate is used as rehabilitation tool in this study. The device is Force Plate coupled with SPARTA scan software that enables quick assessment of individual movement and balance within minutes. The magnitude as well as efficiency of force production is analyzed to determine an patient recovery graph.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. In this study, force plate is rehab tool, which 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)

55

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
      • Stanford, California, United States, 94305
        • Stanford University

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: Supportive Care
  • 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, SPARTA Platform 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: SPARTA force plate
The Sparta Platform includes force plate hardware coupled with Sparta Scan software that enables quick assessment of an individual's movement and balance within minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay in Hospital Through Discharge
Time Frame: Up to 8 days
Length of stay will depend on the score generated by device.
Up to 8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Aid Use
Time Frame: Preoperative and month 3 post-surgery
The gait aide use ranges in the order of decreasing performance as Nothing > Cane/Walking Sticks > crutch > walker.
Preoperative and month 3 post-surgery
Knee Society Score (KSS)
Time Frame: Month 3 post-surgery
To assess the effectiveness of the device by calculating Knee Society Score (KSS) at 3 months following 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.
Month 3 post-surgery
Range of Motion
Time Frame: Preoperative and month 3 post-surgery

To assess the effectiveness of the device by calculating range of motion (extension and flexion).

Higher extension scores and lower flexion scores represent greater flexibility.
Preoperative and month 3 post-surgery

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)

April 19, 2022

Study Completion (Actual)

April 19, 2022

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 48386

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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