Anterior Cruciate Ligament Reconstruction
Conditions
Keywords
Anterior Cruciate Ligament Reconstruction, Wearable device, Knee, Neuromuscular Electrical Stimulation, Exercise
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).
Interventions
DEVICEWearable Device(exoRehab)
rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction using Wearable Device (exoRehab)
BEHAVIORALHome rehabilitation program
rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction
Sponsors
Ministry of SMEs and Startups, Korea
Exosystems CO.,Ltd
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps muscle strength using dynamometry | Baseline and 6 weeks | Change from baseline quadriceps muscle strength at 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Passive range of motion of knee | Baseline, 2 weeks and 6 weeks | Change from baseline passive range of motion of knee at 2 and 6 weeks |
| Root mean square of surface electromyography of quadriceps muscle | Baseline, 2 weeks and 6 weeks | Change from baseline root mean square of surface electromyography of quadriceps muscle at 2 weeks and 6 weeks |
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score | Baseline, 2 weeks and 6 weeks | Changes from baseline in International Knee Documentation Committee (IKDC) subjective score at 2 weeks and 6 weeks, Higher scores indicate better recovery |
| Active range of motion of knee | Baseline, 2 weeks and 6 weeks | Change from baseline active range of motion of knee at 2 weeks and 6 weeks |
| Knee Outcome Survey-Activities of Daily Living Scale | Baseline, 2 weeks and 6 weeks | Change from baseline in score of Knee Outcome Survey-Activities of Daily Living Scale at 2 weeks and 6 weeks. Score ranges from 0-100 with higher scores indicating better knee joint function. |
| EQ-5D-3L Scores | Baseline, 2 weeks and 6 weeks | Change from baseline in EQ-5D-3L Scores at 2 weeks and 6 weeks. EQ-5D-3L is made up for two components. First, the health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. Second, the evaluation part involves an analogue scale, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to the worst health you can imagine, and hundred corresponds to the best health you can imagine. |
| Visual Analogue Scale for pain | Baseline, 2 weeks and 6 weeks | Change from baseline in Visual Analogue Scale at 2 weeks and 6 weeks. The Visual Analogue Scale(VAS), a 101-point scale for evaluating pain which consists of a 100-millimetre scale ranging from 0 (no pain at all) to 100 (worst imaginable pain). |
| Lysholm score | Baseline, 2 weeks and 6 weeks | Change from baseline in Lysholm score at 2 weeks and 6 weeks. Lysholm score ranges from 0-100 with higher scores indicating better knee joint function. |
Countries
South Korea
Outcome results
None listed