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Due to difficulty in patient enrollment
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| Name | Class |
|---|---|
| Ministry of SMEs and Startups, Korea | UNKNOWN |
| Exosystems CO.,Ltd | UNKNOWN |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home rehabilitation using Wearable Device | Experimental | Home rehabilitation using Wearable Device(exoRehab) |
|
| Control | Active Comparator | Standard home rehabilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Device(exoRehab) | Device | rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction using Wearable Device (exoRehab) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps muscle strength using dynamometry | Change from baseline quadriceps muscle strength at 6 weeks | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Active range of motion of knee | Change from baseline active range of motion of knee at 2 weeks and 6 weeks | Baseline, 2 weeks and 6 weeks |
| Passive range of motion of knee | Change from baseline passive range of motion of knee at 2 and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nam-Jong Paik, Ph.D | Seoul National University Bundang Hospital, Seongnam, South Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32443364 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 8, 2026 | |
| Reset | Jan 29, 2026 |
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| Home rehabilitation program | Behavioral | rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction |
|
| Baseline, 2 weeks and 6 weeks |
| Root mean square of surface electromyography of quadriceps muscle | Change from baseline root mean square of surface electromyography of quadriceps muscle at 2 weeks and 6 weeks | Baseline, 2 weeks and 6 weeks |
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score | Changes from baseline in International Knee Documentation Committee (IKDC) subjective score at 2 weeks and 6 weeks, Higher scores indicate better recovery | Baseline, 2 weeks and 6 weeks |
| Lysholm score | 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. | Baseline, 2 weeks and 6 weeks |
| Knee Outcome Survey-Activities of Daily Living Scale | 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. | Baseline, 2 weeks and 6 weeks |
| EQ-5D-3L Scores | 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". | Baseline, 2 weeks and 6 weeks |
| Visual Analogue Scale for pain | 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). | Baseline, 2 weeks and 6 weeks |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 8, 2026 | Jan 29, 2026 |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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