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
1 other identifier
interventional
9
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedStudy Start
First participant enrolled
September 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2018
CompletedMay 30, 2018
May 1, 2018
8 months
June 6, 2017
May 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change of VAS
1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Other Outcomes (3)
Change of ROM
1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Change of drug consumption
5 day, and 10 day after the initiation of intervention
Change of 6 minute walk test
1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Study Arms (2)
Morning walk
EXPERIMENTAL200 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)
No Morning walk
ACTIVE COMPARATOR200 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
Interventions
Eligibility Criteria
You may qualify if:
- Patients underwent Unilateral or both Total Knee Arthroplasty
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulsan University Hospitallead
- Ministry of Health & Welfare, Koreacollaborator
Study Sites (1)
Ulsan University Hospital
Ulsan, 682-714, South Korea
Study Officials
- STUDY DIRECTOR
Chang Ho Hwang, M.D., Ph.D.
Ulsan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD and MD
Study Record Dates
First Submitted
June 6, 2017
First Posted
June 12, 2017
Study Start
September 15, 2017
Primary Completion
May 25, 2018
Study Completion
May 25, 2018
Last Updated
May 30, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share