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Completed

NCT Number: NCT02962453

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Knee

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 intervention start primary end point; 3 days after intervention start secondary end point; 5 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 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

Treatment and study plan

Morning walk

Device

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

Other names: end-effector type robot

Ground Walker

Device

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

Primary outcomes

  1. Change of Isometric muscle strength

    Time frame: 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 outcomes

  1. Change of Cortico-motor Excitability

    Time frame: 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)

  2. Change of Spinal Motor-neuron Excitability

    Time frame: 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*㎡)

  3. Change of Cross-sectional area and volume of thigh muscle

    Time frame: 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)

  4. Change of Muscle work

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ulsan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2016
Registry last updated
Jul 2, 2017

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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