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

June 30, 2017 updated by: Chang Ho Hwang, Ulsan University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Morning walk
Rehabilitation using end-effector type gait robot for 5days.
Device: Morning walk
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
Active Comparator: Ground Walker
Rehabilitation using walker for 5days.
Device: Ground Walker
gait training with ground walker until corresponding 200 steps during 5 minutes with 5 minute break a day over 5 weekdays

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
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*㎡)
0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
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)
0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
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)
0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ulsan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • chhwang6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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