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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Device: Morning walk; Device: Ground Walker

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ulsan, Korea, Republic of, 682-714
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Ulsan University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): May 15, 2017
• Study Completion (Actual): May 15, 2017

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: chhwang6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO