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Completed

NCT Number: NCT03183856

Comparison of Ambulatory and Functional Improvement by 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.

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Key information

Conditions

Arthroplasty, Replacement, Knee Robotics

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ulsan University Hospital

Ulsan, 682-714, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morning walk

Device

a end-effector typed gait robot with a saddle

no Morning walk

Other

ambulation voluntary or with a help of walker

Primary outcomes

  1. Change of WOMAC index

    Time frame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention

    Western Ontario and McMaster Universities Osteoarthritis Index

Secondary outcomes

  1. Change of VAS

    Time frame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention

    visual analogue scale

Other outcomes

  1. Change of ROM

    Time frame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention

    range of motion of the operated knee

  2. Change of drug consumption

    Time frame: 5 day, and 10 day after the initiation of intervention

    weekly amount of tridol consumption

  3. Change of 6 minute walk test

    Time frame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention

    6 minute walk test

Sponsors and collaborators

Lead sponsor

Ulsan University Hospital

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2017
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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