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

NCT ID: NCT02962453

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-05-15

Brief Summary

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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

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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

Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Morning walk

Rehabilitation using end-effector type gait robot for 5days.

Group Type EXPERIMENTAL

Morning walk

Intervention Type DEVICE

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

Ground Walker

Rehabilitation using walker for 5days.

Group Type ACTIVE_COMPARATOR

Ground Walker

Intervention Type DEVICE

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

Interventions

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Morning walk

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

Intervention Type DEVICE

Ground Walker

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

Intervention Type DEVICE

Other Intervention Names

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end-effector type robot

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Ho Hwang

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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chhwang6

Identifier Type: -

Identifier Source: org_study_id

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