Comparison of Ambulatory and Functional Improvement by Morning Walk

Comparison of Clinical Efficacy and Safety for Ambulatory and Functional Improvement in Patients After Total Knee Arthroplasty With Morning Walk

The aim of this study is to determine the clinical efficacy and feasability of gait rehabilitation robot through approving functional improvement by an end-effector typed gait robot in patients underwent total knee arthroplasty.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee; Robotics
• Intervention / Treatment: Device: Morning walk; Other: no Morning walk

Detailed Description

pre-interventional evaluation; within 1 day of initiation of the intervention; 5 days after initiation of the intervention; 10 days after intervention after initiation of the intervention; 42 days after intervention start

• Study Type: Interventional
• Enrollment (Actual): 9
• 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 underwent Unilateral or both 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morning walk; 200 steps of gait rehabilitation using an end-effector typed gait robot with 5 minute break, 3 times a day for 10 weekdays: the end-effector type gait robot (Morning Walk®, Hyundai Heavy Industry, Republic of Korea)	Device: Morning walk; a end-effector typed gait robot with a saddle
Active Comparator: No Morning walk; 200 steps by themselves or with a help of a walker on a even floor at a comfortable pace with 5 minute break, three times a day for 10 weekdays	Other: no Morning walk; ambulation voluntary or with a help of walker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of WOMAC index	Western Ontario and McMaster Universities Osteoarthritis Index	1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of VAS	visual analogue scale	1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of ROM	range of motion of the operated knee	1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Change of drug consumption	weekly amount of tridol consumption	5 day, and 10 day after the initiation of intervention
Change of 6 minute walk test	6 minute walk test	1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention

Collaborators and Investigators

• Sponsor: Ulsan University Hospital
• Collaborators: Ministry of Health & Welfare, Korea
• Investigators: Study Director: Chang Ho Hwang, M.D., Ph.D., Ulsan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): May 25, 2018
• Study Completion (Actual): May 25, 2018

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 27, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: chhwang7

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No