Arthroplasty, Replacement, KneeNCT02962453
Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway in Patients After Knee Arthroplasty
A study testing Morning walk and Ground Walker in people with Arthroplasty, Replacement, Knee, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to determine the clinical efficacy of gait rehabilitation robot through cortico-spinal-muscular pathway activation of the muscles remotely located from the end-effecter in patients after total knee arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Morning walk and Ground Walker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to 15 May 2017
- 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 after Unilateral 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: Multi-Modalities Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway of the Proximal Muscles in Patients After Total Knee Arthroplasty
The aim of this study is to determine the clinical efficacy of gait rehabilitation robot through cortico-spinal-muscular pathway activation of the muscles remotely located from the end-effecter in patients after total knee arthroplasty.
Read the detailed description
pre-interventional evaluation; within 1 day of intervention start primary end point; 3 days after intervention start secondary end point; 5 days after intervention start
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Morning walk, Ground Walker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning walkDevice
Also called end-effector type robot
gait training with Morning walk three times during 5 minutes with 5 minute break a day over 5 weekdays
Ground WalkerDevice
gait training with ground walker until corresponding 200 steps during 5 minutes with 5 minute break a day over 5 weekdays
| Study group | Role | What they receive |
|---|---|---|
| Morning walk | Experimental | Rehabilitation using end-effector type gait robot for 5days. Receives: Device: Morning walk |
| Ground Walker | Active comparator | Rehabilitation using walker for 5days. Receives: Device: Ground Walker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Isometric muscle strength
peak torque (Nm/㎡), Maximal ratio of torque development (RTD) (degree/sec)
Measured: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Secondary outcomes (4)
Change of Cortico-motor Excitability
maximum \& mean amplitude of peak to peak MEP (mV and mV), amplitude of peak to peak MEP/maximum M-wave (mV/mV)
Measured: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Change of Spinal Motor-neuron Excitability
Peak to peak Max. H-reflex (mV/mV), Peak to peak Max. H-wave/Max. M-reflex (mV/mV*㎡)
Measured: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Change of Cross-sectional area and volume of thigh muscle
Cross-sectional area (c㎡) and and volume (cm3)
Measured: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Change of Muscle work
peak and mean amplitude of CMAP (mV and mV) and mean area \& total area of CMAP (c㎡/sec and c㎡/sec)
Measured: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion15 May 2017
- Study completion15 May 2017
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Ho Hwang, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962453
- Sponsor's protocol ID
- chhwang6
- Status last verified
- Jun 2017
- First submitted
- 2 Nov 2016
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Modalities Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway of the Proximal Muscles in Patients After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02962453
- Acronym / sponsor ID
- chhwang6
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 11 Nov 2016 (estimated)
- 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 of gait rehabilitation robot through cortico-spinal-muscular pathway activation of the muscles remotely located from the end-effecter in patients after total knee arthroplasty.
Detailed description
pre-interventional evaluation; within 1 day of intervention start primary end point; 3 days after intervention start secondary end point; 5 days after intervention start
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning walk | Experimental | Device: Morning walkRehabilitation using end-effector type gait robot for 5days. |
| Ground Walker | Active comparator | Device: Ground WalkerRehabilitation using walker for 5days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients after Unilateral 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 walkAlso: end-effector type robotgait training with Morning walk three times during 5 minutes with 5 minute break a day over 5 weekdays | Device | Morning walk |
| Ground Walkergait training with ground walker until corresponding 200 steps during 5 minutes with 5 minute break a day over 5 weekdays | Device | Ground Walker |
Primary outcome
Change of Isometric muscle strength
Time frame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
peak torque (Nm/㎡), Maximal ratio of torque development (RTD) (degree/sec)
4 secondary outcomes
Change of Cortico-motor Excitability
Time frame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Change of Spinal Motor-neuron Excitability
Time frame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Change of Cross-sectional area and volume of thigh muscle
Time frame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Change of Muscle work
Time frame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
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 2 Jul 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ground Walker in people with Arthroplasty, Replacement, Knee, 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 2 Jul 2017. 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 Isometric muscle strength (time frame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)). 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 2 Jul 2017.