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

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962453
• Other study ID #: chhwang6
• Status: Completed
• Phase: N/A
• First received: November 2, 2016
• Last updated: June 30, 2017
• Start date: November 2016
• Est. completion date: May 15, 2017

Study information

• Verified date: June 2017
• 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• Morning walk
gait training with Morning walk three times during 5 minutes with 5 minute break a day over 5 weekdays
• Ground Walker
gait training with ground walker until corresponding 200 steps during 5 minutes with 5 minute break a day over 5 weekdays

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)