Home Rehabilitation Using Smart Wearable Exercise and Electrical Stimulation Device After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT04079205

Last Updated: 2021-09-27

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

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2021-06-30

Brief Summary

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The purpose of this study is to develop and apply a rehabilitation program for patients who are discharged after ACL reconstruction using a wearable joint rehabilitation exercise device (exoRehab).

Detailed Description

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This randomized, single-blind, controlled trial included 40 patients who are discharged after ACL reconstruction.

The intervention group(n=20) was instructed and educated about 6 week home rehabilitation program using a wearable device(exoRehab)

The controls(n=20) was instructed and educated about 6 week conventional home rehabilitation program

Two weeks after surgery and six weeks after discharge, evaluation is performed.

The purpose of this study is to develop and apply a rehabilitation program for patients who are discharged after ACL reconstruction using a wearable joint rehabilitation exercise device (exoRehab).

Conditions

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Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home rehabilitation using Wearable Device

Home rehabilitation using Wearable Device(exoRehab)

Group Type EXPERIMENTAL

Wearable Device(exoRehab)

Intervention Type DEVICE

rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction using Wearable Device (exoRehab)

Control

Standard home rehabilitation program

Group Type ACTIVE_COMPARATOR

Home rehabilitation program

Intervention Type BEHAVIORAL

rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction

Interventions

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Wearable Device(exoRehab)

rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction using Wearable Device (exoRehab)

Intervention Type DEVICE

Home rehabilitation program

rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients with anterior cruciate ligament reconstruction
* Patients who are older than 19 years of age

Exclusion Criteria

* History of surgery or traumatic injury to the uninvolved lower extremity
* Complication after ACL reconstruction surgery
* Dermatological conditions affecting the thigh
* Body mass index (BMI) greater than 40 kg/m2
* Implanted pacemakers or defibrillators
* Significant neurologic impairments
* Other unstable lower-extremity orthopedic conditions
* Initiated rehabilitation at another facility prior to their first physical therapy session at our facility
* Other lower limb impairment affecting function
* More than one surgery for a tear of the ACL
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of SMEs and Startups, Korea

UNKNOWN

Sponsor Role collaborator

Exosystems CO.,Ltd

UNKNOWN

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nam-Jong Paik

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nam-Jong Paik, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital, Seongnam, South Korea

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Kim G, Kim WS, Kim TW, Lee YS, Lee H, Paik NJ. Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation after anterior cruciate ligament reconstruction: A study protocol for a randomized controlled trial. Medicine (Baltimore). 2020 May;99(20):e20256. doi: 10.1097/MD.0000000000020256.

Reference Type DERIVED
PMID: 32443364 (View on PubMed)

Other Identifiers

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B-1806-475-006

Identifier Type: -

Identifier Source: org_study_id

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