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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02962453

Enrollment

Registered

2016-11-11

Start date

2016-11-30

Completion date

2017-05-15

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee

Brief 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.

Detailed 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

Interventions

DEVICEMorning walk

gait training with Morning walk three times during 5 minutes with 5 minute break a day over 5 weekdays

DEVICEGround Walker

gait training with ground walker until corresponding 200 steps during 5 minutes with 5 minute break a day over 5 weekdays

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of Isometric muscle strength	0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)	peak torque (Nm/㎡), Maximal ratio of torque development (RTD) (degree/sec)

Secondary

Measure	Time frame	Description
Change of Cortico-motor Excitability	0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)	maximum & mean amplitude of peak to peak MEP (mV and mV), amplitude of peak to peak MEP/maximum M-wave (mV/mV)
Change of Spinal Motor-neuron Excitability	0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)	Peak to peak Max. H-reflex (mV/mV), Peak to peak Max. H-wave/Max. M-reflex (mV/mV\*㎡)
Change of Cross-sectional area and volume of thigh muscle	0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)	Cross-sectional area (c㎡) and and volume (cm3)
Change of Muscle work	0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)	peak and mean amplitude of CMAP (mV and mV) and mean area & total area of CMAP (c㎡/sec and c㎡/sec)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026