Comparison of Ambulatory and Functional Improvement by Morning Walk

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183856
• Other study ID #: chhwang7
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: May 25, 2018

Study information

• Verified date: May 2018
• Source: Ulsan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 25, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Robotics

Intervention

Device:
• Morning walk
a end-effector typed gait robot with a saddle

Other:
• no Morning walk
ambulation voluntary or with a help of walker

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Ulsan University Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change of drug consumption	weekly amount of tridol consumption	5 day, and 10 day after the initiation of intervention
Other	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
Primary	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	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