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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: Morning walk
* Device: Ground Walker


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morning walk<br>Rehabilitation using end-effector type gait robot for 5days. | Device: Morning walk<br>* gait training with Morning walk three times during 5 minutes with 5 minute break a day over 5 weekdays<br>* Other names: end-effector type robot;|
| Active Comparator: Ground Walker<br>Rehabilitation using walker for 5days. | Device: Ground Walker<br>* gait training with ground walker until corresponding 200 steps during 5 minutes with 5 minute break a day over 5 weekdays<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Isometric muscle strength | peak torque (Nm/㎡), Maximal ratio of torque development (RTD) (degree/sec) | 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop) | 

Secondary Outcome Measures

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