Osteoarthritis, KneeNCT03476148
Home Rehabilitation Using Interactive Device Versus Inpatient Rehabilitation in Total Knee Arthroplasty
A study testing Home Rehabilitation using Interactive device and Inpatient Rehabilitation in people with Osteoarthritis, Knee and Arthroplasty, run by The Catholic University of Korea.
Trial summary
Rehabilitation after total knee arthroplasty is very important in terms of range of motion of the knee, muscle power, normal gait, pain control and consequently the patient's satisfaction. Convectional rehabilitation methods in assist of therapist required high demand of resources. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Osteoarthritis, Knee, Arthroplasty, Rehabilitation
- What is being tested?
- Home Rehabilitation using Interactive device and Inpatient Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2018to 21 Mar 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 19 year old
- Patients for total knee arthroplasty of one knee
- Patients who can understand and utilize the device
Who cannot join
- who don't agree with participation of the study
- who can not understand and utilize the device
- Rheumatoid arthritis, Other inflammatory arthritis
- Neuropsychiatric patients
About this study
Official title: Effect of Home-Based Rehabilitation Using Interactive Motion Tracking Device on Function and Patient Satisfaction After Total Knee Arthroplasty
Rehabilitation after total knee arthroplasty is very important in terms of range of motion of the knee, muscle power, normal gait, pain control and consequently the patient's satisfaction. Convectional rehabilitation methods in assist of therapist required high demand of resources. Recently, outpatient clinic or tele-communication tool based rehabilitations were investigated and reported equivalent results. However, those methods also required group or one-to-one facing that restricted availability of the exercise.
With development of the motion tracking technology, new device that gives real time feedback with augmented reality images can be used for rehabilitation in home-based setting.
This study aims to compare the clinical outcomes after the rehabilitation by interactive home-based device or conventional inpatient setting.
Read the detailed description
The objective of this work is to compare the pain, stiffness, function and satisfaction between groups at 6 months after the total knee arthroplasty.
The investigators hypothesized that the clinical outcomes of rehabilitation by interactive home-based device are not inferior than that by conventional inpatient setting.
The study design is a single-blind non-randomized controlled trial. Patients takes different rehabilitation method but the outcome assessor is blinded. The clinical outcome is compared at preoperative, postoperative 6weeks, 3months. And clinical outcome consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index ) score, Knee Society Score, Time-up-go (TUG) test.
- Conditions
- Osteoarthritis, Knee, Arthroplasty, Rehabilitation
- Being tested
- Home Rehabilitation using Interactive device, Inpatient Rehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Rehabilitation using Interactive deviceDevice
Rehabilitation is performed using interactive motion tracking augmented reality device. 6 exercises are included in one-day rehabilitation program. Each exercise is recorded in aspect of compliance, completion.
Inpatient RehabilitationOther
Patients are given the exercises in the setting of inpatient rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Interactive Device Rehabilitation | Experimental | Not described Receives: Device: Home Rehabilitation using Interactive device |
| Inpatient Rehabilitation | Active comparator | Not described Receives: Other: Inpatient Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Measured: preoperative, postoperative at 6, 12 weeks
Change in Knee Society Score
Measured: preoperative, postoperative at 6, 12 weeks
Change in Time-Up-Go (TUG) test
Measured: preoperative, postoperative at 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start22 Mar 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion21 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476148
- Sponsor's protocol ID
- Rehab. Home vs inpatient
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home-Based Rehabilitation Using Interactive Motion Tracking Device on Function and Patient Satisfaction After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03476148
- Acronym / sponsor ID
- Rehab. Home vs inpatient
- Conditions
- Osteoarthritis, Knee, Arthroplasty, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 22 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 21 Mar 2020 (estimated)
- First posted
- 23 Mar 2018 (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.
Rehabilitation after total knee arthroplasty is very important in terms of range of motion of the knee, muscle power, normal gait, pain control and consequently the patient's satisfaction. Convectional rehabilitation methods in assist of therapist required high demand of resources. Recently, outpatient clinic or tele-communication tool based rehabilitations were investigated and reported equivalent results. However, those methods also required group or one-to-one facing that restricted availability of the exercise.
With development of the motion tracking technology, new device that gives real time feedback with augmented reality images can be used for rehabilitation in home-based setting.
This study aims to compare the clinical outcomes after the rehabilitation by interactive home-based device or conventional inpatient setting.
Detailed description
The objective of this work is to compare the pain, stiffness, function and satisfaction between groups at 6 months after the total knee arthroplasty.
The investigators hypothesized that the clinical outcomes of rehabilitation by interactive home-based device are not inferior than that by conventional inpatient setting.
The study design is a single-blind non-randomized controlled trial. Patients takes different rehabilitation method but the outcome assessor is blinded. The clinical outcome is compared at preoperative, postoperative 6weeks, 3months. And clinical outcome consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index ) score, Knee Society Score, Time-up-go (TUG) test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Device Rehabilitation | Experimental | Device: Home Rehabilitation using Interactive device |
| Inpatient Rehabilitation | Active comparator | Other: Inpatient Rehabilitation |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 19 year old
- Patients for total knee arthroplasty of one knee
- Patients who can understand and utilize the device
Key exclusion criteria (4 listed)
- who don't agree with participation of the study
- who can not understand and utilize the device
- Rheumatoid arthritis, Other inflammatory arthritis
- Neuropsychiatric patients
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 |
|---|---|---|
| Home Rehabilitation using Interactive deviceRehabilitation is performed using interactive motion tracking augmented reality device. 6 exercises are included in one-day rehabilitation program. Each exercise is recorded in aspect of compliance, completion. | Device | Interactive Device Rehabilitation |
| Inpatient RehabilitationPatients are given the exercises in the setting of inpatient rehabilitation | Other | Inpatient Rehabilitation |
Primary outcome
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Time frame: preoperative, postoperative at 6, 12 weeks
Change in Knee Society Score
Time frame: preoperative, postoperative at 6, 12 weeks
Change in Time-Up-Go (TUG) test
Time frame: preoperative, postoperative at 6, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Home Rehabilitation using Interactive device and Inpatient Rehabilitation in people with Osteoarthritis, Knee and Arthroplasty, run by The Catholic University of 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in Western Ontario and McMaster Universities Index(WOMAC index) (time frame: preoperative, postoperative at 6, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2018.