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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03777007
Other study ID # 48386
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 26, 2019
Est. completion date April 19, 2022

Study information

Verified date March 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date April 19, 2022
Est. primary completion date April 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Derek Amanatullah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of Stay in Hospital Through Discharge Length of stay will depend on the score generated by device. Up to 8 days
Secondary Gait Aid Use The gait aide use ranges in the order of decreasing performance as Nothing > Cane/Walking Sticks > crutch > walker. Preoperative and month 3 post-surgery
Secondary Knee Society Score (KSS) 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
Secondary Range of Motion 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
See also
  Status Clinical Trial Phase
Terminated NCT03776357 - A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement N/A