Does Supplementing of Quadriceps Strength With Exoskeleton After Total Knee Arthroplasty in High Risk Population Reduce Transfer to Extended Care Facility (ECF)

Not Applicable

Withdrawn

• Conditions: Primary Knee Replacement Surgery
• Interventions: Device: Robotic exoskeleton device

• Registration Number: NCT03762603
• Lead Sponsor: Stanford University

Brief Summary

This study involves an exoskeleton which is believed to increase quadriceps muscle strength in the rehabilitation phase after TKA and reduce the discharge the such patients in Extended care facility (ECF) . The purpose of this study is to access efficacy of the robotic exoskeleton device wrapped around the operated knee on patients

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Start: 2021-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-03
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
robotic exoskeleton device	Robotic exoskeleton device	Patients who are scheduled to be discharged to a ECF will be asked if they would want to use the exoskeleton device ( for which safety and comfort has been established) instead of going for ECF.

Primary Outcome Measures

Name	Time	Method
Predicting discharge location after TKA	2 years	The objective of this study is to observe how many patients are not transferred to ECF in the post-surgery time period as a result of using a robotic exoskeleton on operated knee. We will list number of patients NOT going for ECF.

Secondary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up	2 weeks and 3 months	To assess the effectiveness of device by calculating Initial satisfaction with the device and satisfaction at 2 weeks and 3 months after surgery using a questionnaire. The scale ranges from: Very satisfied Satisfied Neutral Not satisfied
Evaluate the effectiveness of the robotic exoskeleton device at time of discharge	upto 2 weeks	Determining patients performance of Stairs at discharge. Patients at the time of discharge are asked to step 3 stairs and answer related questions using a questionnaire
Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years	up to 2 years	calculating Timed-up-and-Go at discharge, 3 months and 2 years after surgery

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States