NCT04079205

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

2.5 years

First QC Date

May 8, 2019

Last Update Submit

September 20, 2021

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Anterior Cruciate Ligament ReconstructionWearable deviceKneeNeuromuscular Electrical StimulationExercise

Outcome Measures

Primary Outcomes (1)

  • Quadriceps muscle strength using dynamometry

    Change from baseline quadriceps muscle strength at 6 weeks

    Baseline and 6 weeks

Secondary Outcomes (8)

  • Active range of motion of knee

    Baseline, 2 weeks and 6 weeks

  • Passive range of motion of knee

    Baseline, 2 weeks and 6 weeks

  • Root mean square of surface electromyography of quadriceps muscle

    Baseline, 2 weeks and 6 weeks

  • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score

    Baseline, 2 weeks and 6 weeks

  • Lysholm score

    Baseline, 2 weeks and 6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Home rehabilitation using Wearable Device

EXPERIMENTAL

Home rehabilitation using Wearable Device(exoRehab)

Device: Wearable Device(exoRehab)

Control

ACTIVE COMPARATOR

Standard home rehabilitation program

Behavioral: Home rehabilitation program

Interventions

Wearable Device(exoRehab)DEVICE

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

Home rehabilitation using Wearable Device
Home rehabilitation programBEHAVIORAL

rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction

Control

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32443364DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nam-Jong Paik, Ph.D

    Seoul National University Bundang Hospital, Seongnam, South Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 8, 2019

First Posted

September 6, 2019

Study Start

December 31, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 27, 2021

Record last verified: 2021-09

Locations

KR(1)