Anterior Cruciate Ligament ReconstructionNCT04079205
Home Rehabilitation Using Smart Wearable Exercise and Electrical Stimulation Device After Anterior Cruciate Ligament Reconstruction
A study testing Wearable Device(exoRehab) and Home rehabilitation program in people with Anterior Cruciate Ligament Reconstruction, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Wearable Device(exoRehab) and Home rehabilitation program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Dec 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with anterior cruciate ligament reconstruction
- Patients who are older than 19 years of age
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
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
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).
Read the 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).
- Being tested
- Wearable Device(exoRehab), Home rehabilitation program
- Keywords
- Anterior Cruciate Ligament Reconstruction, Wearable device, Knee, Neuromuscular Electrical Stimulation, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Device(exoRehab)Device
rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction using Wearable Device (exoRehab)
Home rehabilitation programBehavioural
rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Home rehabilitation using Wearable Device | Experimental | Home rehabilitation using Wearable Device(exoRehab) Receives: Device: Wearable Device(exoRehab) |
| Control | Active comparator | Standard home rehabilitation program Receives: Behavioral: Home rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle strength using dynamometry
Change from baseline quadriceps muscle strength at 6 weeks
Measured: Baseline and 6 weeks
Secondary outcomes (8)
Active range of motion of knee
Change from baseline active range of motion of knee at 2 weeks and 6 weeks
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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).
Measured: Baseline, 2 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start31 Dec 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Due to difficulty in patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of SMEs and Startups, Korea, Exosystems CO.,Ltd
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
- Investigators
- Nam-Jong Paik, Ph.D, Principal investigator, Seoul National University Bundang Hospital, Seongnam, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079205
- Sponsor's protocol ID
- B-1806-475-006
- Status last verified
- Sep 2021
- First submitted
- 8 May 2019
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32443364
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04079205
- Acronym / sponsor ID
- B-1806-475-006
- Keywords
- Anterior Cruciate Ligament Reconstruction, Wearable device, Knee, Neuromuscular Electrical Stimulation, Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulty in patient enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Ministry of SMEs and Startups, Korea, Exosystems CO.,Ltd
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home rehabilitation using Wearable Device | Experimental | Device: Wearable Device(exoRehab)Home rehabilitation using Wearable Device(exoRehab) |
| Control | Active comparator | Behavioral: Home rehabilitation programStandard home rehabilitation program |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with anterior cruciate ligament reconstruction
- Patients who are older than 19 years of age
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Device(exoRehab)rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction using Wearable Device (exoRehab) | Device | Home rehabilitation using Wearable Device |
| Home rehabilitation programrehabilitation program for patients after Anterior Cruciate Ligament Reconstruction | Behavioural | Control |
Primary outcome
Quadriceps muscle strength using dynamometry
Time frame: Baseline and 6 weeks
Change from baseline quadriceps muscle strength at 6 weeks
8 secondary outcomes
Active range of motion of knee
Time frame: Baseline, 2 weeks and 6 weeks
Passive range of motion of knee
Time frame: Baseline, 2 weeks and 6 weeks
Root mean square of surface electromyography of quadriceps muscle
Time frame: Baseline, 2 weeks and 6 weeks
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
Time frame: Baseline, 2 weeks and 6 weeks
Lysholm score
Time frame: Baseline, 2 weeks and 6 weeks
Knee Outcome Survey-Activities of Daily Living Scale
Time frame: Baseline, 2 weeks and 6 weeks
EQ-5D-3L Scores
Time frame: Baseline, 2 weeks and 6 weeks
Visual Analogue Scale for pain
Time frame: Baseline, 2 weeks and 6 weeks
Results and safety
The study was stopped early (reason given: Due to difficulty in patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Derived from this study: PubMed 32443364Kim 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.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Cruciate Ligament Reconstruction
Not yet recruiting
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction Rehabilitation, Dry Needling
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
The Effect of Isokinetic Vs Plyometric Training in Post-ACLR Surgery
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Reconstruction Rehabilitation
Recruiting
The Effect of Plyometric Training in Post-ACLR Surgery
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Reconstruction Rehabilitation
RecruitingPhase 4
Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees
Anterior Cruciate Ligament Reconstruction, Medial Patellofemoral Ligament Reconstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nam-Jong Paik, Ph.D principal investigator
Seoul National University Bundang Hospital, Seongnam, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Device(exoRehab) and Home rehabilitation program in people with Anterior Cruciate Ligament Reconstruction, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to difficulty in patient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps muscle strength using dynamometry (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04079205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021; AzTrials last refreshed its copy on 30 Oct 2026.