Clinical trial NCT04079205: Home Rehabilitation Using Smart Wearable Exercise and Electrical Stimulation Device After Anterior Cruciate Ligament Reconstruction
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Anterior Cruciate Ligament Reconstruction
Wearable device
Knee
Neuromuscular Electrical Stimulation
Exercise
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of SMEs and Startups, Korea
name: Exosystems CO.,Ltd
First posted: 2019-09-06
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Quadriceps muscle strength using dynamometry
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Active range of motion of knee
timeFrame: Baseline, 2 weeks and 6 weeks
measure: Passive range of motion of knee
timeFrame: Baseline, 2 weeks and 6 weeks
measure: Root mean square of surface electromyography of quadriceps muscle
timeFrame: Baseline, 2 weeks and 6 weeks
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
timeFrame: Baseline, 2 weeks and 6 weeks
measure: Lysholm score
timeFrame: Baseline, 2 weeks and 6 weeks
measure: Knee Outcome Survey-Activities of Daily Living Scale
timeFrame: Baseline, 2 weeks and 6 weeks
measure: EQ-5D-3L Scores
timeFrame: Baseline, 2 weeks and 6 weeks
measure: Visual Analogue Scale for pain
timeFrame: Baseline, 2 weeks and 6 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital, Seongnam, South Korea
name: Nam-Jong Paik, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.