Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway in Patients After Knee Arthroplasty

Not Applicable

Completed

• Conditions: Arthroplasty, Replacement, Knee

• Registration Number: NCT02962453
• Lead Sponsor: Ulsan University Hospital

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

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-11
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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
• MMSE<23
• history of arthroplasty surgery on either of legs
• Cardiac pacemaker
• Refusal of participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of Isometric muscle strength	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 Outcome Measures

Name	Time	Method
Change of Spinal Motor-neuron Excitability	0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)	Peak to peak Max. H-reflex (mV/mV), Peak to peak Max. H-wave/Max. M-reflex (mV/mV\*㎡)
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)	Cross-sectional area (c㎡) and and volume (cm3)
Change of Cortico-motor Excitability	0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)	maximum \& mean amplitude of peak to peak MEP (mV and mV), amplitude of peak to peak MEP/maximum M-wave (mV/mV)
Change of Muscle work	0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)	peak and mean amplitude of CMAP (mV and mV) and mean area \& total area of CMAP (c㎡/sec and c㎡/sec)

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of