Arthroplasty, Replacement, KneeNCT03183856
Comparison of Ambulatory and Functional Improvement by Morning Walk
A study testing Morning walk and no Morning walk in people with Arthroplasty, Replacement, Knee and Robotics, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to determine the clinical efficacy and feasability of gait rehabilitation robot through approving functional improvement by an end-effector typed gait robot in patients underwent total knee arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Robotics
- What is being tested?
- Morning walk and no Morning walk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2017to 25 May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients underwent Unilateral or both Total Knee Arthroplasty
Who cannot join
- brain disease, spinal cord injury, peripheral neuropathy, myopathy
- Inability to ambulate fully due to muscukoskeletal disorders
- MMSE<23
- history of arthroplasty surgery on either of legs
- Cardiac pacemaker
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clinical Efficacy and Safety for Ambulatory and Functional Improvement in Patients After Total Knee Arthroplasty With Morning Walk
The aim of this study is to determine the clinical efficacy and feasability of gait rehabilitation robot through approving functional improvement by an end-effector typed gait robot in patients underwent total knee arthroplasty.
Read the detailed description
pre-interventional evaluation; within 1 day of initiation of the intervention; 5 days after initiation of the intervention; 10 days after intervention after initiation of the intervention; 42 days after intervention start
- Conditions
- Arthroplasty, Replacement, Knee, Robotics
- Being tested
- Morning walk, no Morning walk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning walkDevice
a end-effector typed gait robot with a saddle
no Morning walkOther
ambulation voluntary or with a help of walker
| Study group | Role | What they receive |
|---|---|---|
| Morning walk | Experimental | 200 steps of gait rehabilitation using an end-effector typed gait robot with 5 minute break, 3 times a day for 10 weekdays: the end-effector type gait robot (Morning Walk®, Hyundai Heavy Industry, Republic of Korea) Receives: Device: Morning walk |
| No Morning walk | Active comparator | 200 steps by themselves or with a help of a walker on a even floor at a comfortable pace with 5 minute break, three times a day for 10 weekdays Receives: Other: no Morning walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of WOMAC index
Western Ontario and McMaster Universities Osteoarthritis Index
Measured: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Secondary outcomes (1)
Change of VAS
visual analogue scale
Measured: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start15 Sep 2017
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Chang Ho Hwang, Ulsan University Hospital
- Investigators
- Chang Ho Hwang, M.D., Ph.D., Study director, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183856
- Sponsor's protocol ID
- chhwang7
- Status last verified
- May 2018
- First submitted
- 6 Jun 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Efficacy and Safety for Ambulatory and Functional Improvement in Patients After Total Knee Arthroplasty With Morning Walk
- ClinicalTrials.gov ID
- NCT03183856
- Acronym / sponsor ID
- chhwang7
- Conditions
- Arthroplasty, Replacement, Knee, Robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 12 Jun 2017 (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 aim of this study is to determine the clinical efficacy and feasability of gait rehabilitation robot through approving functional improvement by an end-effector typed gait robot in patients underwent total knee arthroplasty.
Detailed description
pre-interventional evaluation; within 1 day of initiation of the intervention; 5 days after initiation of the intervention; 10 days after intervention after initiation of the intervention; 42 days after intervention start
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning walk | Experimental | Device: Morning walk200 steps of gait rehabilitation using an end-effector typed gait robot with 5 minute break, 3 times a day for 10 weekdays: the end-effector type gait robot (Morning Walk®, Hyundai Heavy Industry, Republic of Korea) |
| No Morning walk | Active comparator | Other: no Morning walk200 steps by themselves or with a help of a walker on a even floor at a comfortable pace with 5 minute break, three times a day for 10 weekdays |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients underwent Unilateral or both Total Knee Arthroplasty
Key exclusion criteria (6 listed)
- brain disease, spinal cord injury, peripheral neuropathy, myopathy
- Inability to ambulate fully due to muscukoskeletal disorders
- MMSE<23
- history of arthroplasty surgery on either of legs
- Cardiac pacemaker
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 |
|---|---|---|
| Morning walka end-effector typed gait robot with a saddle | Device | Morning walk |
| no Morning walkambulation voluntary or with a help of walker | Other | No Morning walk |
Primary outcome
Change of WOMAC index
Time frame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Western Ontario and McMaster Universities Osteoarthritis Index
1 secondary outcome
Change of VAS
Time frame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: No
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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.
Chang Ho Hwang, M.D., Ph.D. study director
Ulsan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning walk and no Morning walk in people with Arthroplasty, Replacement, Knee and Robotics, run by Ulsan University 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 30 May 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of WOMAC index (time frame: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention). 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 30 May 2018.