Multi-Modalities Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway of the Proximal Muscles in Patients After Total Knee Arthroplasty

Ulsan University Hospital1 site in 1 country20 target enrollmentNovember 2016

ConditionsArthroplasty, Replacement, Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Ulsan University Hospital
Enrollment: 20
Locations: 1
Primary Endpoint: Change of Isometric muscle strength
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to determine the clinical efficacy of gait rehabilitation robot through cortico-spinal-muscular pathway activation of the muscles remotely located from the end-effecter in patients after total knee arthroplasty.

Detailed Description

pre-interventional evaluation; within 1 day of intervention start primary end point; 3 days after intervention start secondary end point; 5 days after intervention start

Registry

clinicaltrials.gov

Start Date

November 2016

End Date

May 15, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ulsan University Hospital

Responsible Party

Principal Investigator

Chang Ho Hwang

Associated Professor

Ulsan University Hospital

Eligibility Criteria

Inclusion Criteria

•Patients after Unilateral Total Knee Arthroplasty

Exclusion Criteria

•brain disease, spinal cord injury, peripheral neuropathy, myopathy
•Inability to ambulate fully due to muscukoskeletal disorders
•history of arthroplasty surgery on either of legs
•Cardiac pacemaker
•Refusal of participation

Outcomes

Primary Outcomes

Change of Isometric muscle strength

Time Frame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)

peak torque (Nm/㎡), Maximal ratio of torque development (RTD) (degree/sec)

Secondary Outcomes

Change of Spinal Motor-neuron Excitability(0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop))
Change of Cross-sectional area and volume of thigh muscle(0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop))
Change of Cortico-motor Excitability(0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop))
Change of Muscle work(0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop))