StrokeNCT04654793
The Effect of Robotics-assisted Tilt Table and Functional Electrical Stimulation in Stroke Patients
A study testing Robot assisted inclined bed treatment and FES and conventional inclined bed treatment in people with Stroke, run by Yonsei University at 1 site in South Korea.
Trial summary
Among subacute stroke patients (within 4 weeks after the onset), patients who are unable to walk are divided into experimental groups and control groups, and conventional rehabilitation treatment including physical therapy and occupational therapy is performed for 4 weeks or more in all groups. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robot assisted inclined bed treatment and FES and conventional inclined bed treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Mar 2017to Mar 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients within 4 weeks of onset of first stroke
- Patients with an FAC score of 1 or less and at least one lower limb FMA of 15 or less
- Adult male or female over 50 years of age
- Those who have consented in writing to this clinical trial
- A person who understands the purpose of the clinical trial and can adapt well to the treatment process
Who cannot join
- Those with lower motor neuron lesions
- A person who has an artificial implant due to a fracture of the lower extremity and spine, or a metal implant that generates an electrical signal such as an artificial pacemaker.
- Those with a history of bone metabolism related diseases such as thyroid or parathyroid disease (excluding osteopenia and osteoporosis) or bone tumor
- A person who has a history of fracture at the site of bone mineral density (ex. L1-L5, femoral head)
- Those who have skin ulcers or skin diseases such as open wounds that make it difficult to apply robotic therapy
- Those with the construction of the lower extremities
Show all 9Show fewer
- Those with deep vein thrombosis or arterial vascular disease of the lower extremities
- Pregnant women
- Not appropriate according to the judgment of other researchers
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Severance Hospital
Seoul
Deog Young Kim, 82-2-2228-3700, KIMDY@yuhs.ac
About this study
Among subacute stroke patients (within 4 weeks after the onset), patients who are unable to walk are divided into experimental groups and control groups, and conventional rehabilitation treatment including physical therapy and occupational therapy is performed for 4 weeks or more in all groups.
Robot assisted inclined bed treatment and FES were performed, and the control group performed conventional inclined bed treatment.
Read more
The purpose of this study is to investigate the effect of robot-assisted inclined bed treatment by tracking observation and comparative analysis of the lower limb function, gait ability, bone density and muscle mass of each group.
Patients appropriate for the selection criteria are divided into experimental group and control group in random permuted blocks to conduct the study. In the experimental group, FES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks, and the control group performed conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week. Separately from this in all groups, functional electrical stimulation treatment is performed once a day in the area except the lower extremities. In addition, all patients receive palliative physical therapy for 4 weeks for 1 hour a day. All subjects undergo a physical examination and whole body composition assessment before and after 4 weeks of treatment, and f/u after 4 weeks of treatment.
- Conditions
- Stroke
- Being tested
- Robot assisted inclined bed treatment and FES, conventional inclined bed treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted inclined bed treatment and FESDevice
FES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks.
conventional inclined bed treatmentDevice
conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Robot assisted inclined bed treatment and FES Receives: Device: Robot assisted inclined bed treatment and FES |
| Control group | Active comparator | conventional inclined bed treatment Receives: Device: conventional inclined bed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (lower)
A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.
Measured: before intervention
Fugl-Meyer Assessment (lower)
A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.
Measured: 4weeks after
Fugl-Meyer Assessment (lower)
A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.
Measured: 8weeks after
Motricity Index
A tool used to evaluate motor power.
Measured: before intervention
Motricity Index
A tool used to evaluate motor power.
Measured: 4weeks after
Motricity Index
A tool used to evaluate motor power.
Measured: 8weeks after
FAC (Functional ambulatory scale)
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
Measured: before intervention
FAC (Functional ambulatory scale)
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
Measured: 4weeks after
FAC (Functional ambulatory scale)
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
Measured: 8weeks after
Locomotion level of FIM (functional independence measure)
Indicator to evaluate independence in performing daily life movements
Measured: before intervention
Locomotion level of FIM (functional independence measure)
Indicator to evaluate independence in performing daily life movements
Measured: 4weeks after
Locomotion level of FIM (functional independence measure)
Indicator to evaluate independence in performing daily life movements
Measured: 8weeks after
Berg balance scale
A tool to evaluate balance
Measured: before intervention
Berg balance scale
A tool to evaluate balance
Measured: 4weeks after
Berg balance scale
A tool to evaluate balance
Measured: 8weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start17 Mar 2017
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deog Young Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654793
- Sponsor's protocol ID
- 4-2017-0092
- Status last verified
- Dec 2020
- First submitted
- 25 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Robotics-assisted Tilt Table and Functional Electrical Stimulation in Stroke Patients
- ClinicalTrials.gov ID
- NCT04654793
- Acronym / sponsor ID
- 4-2017-0092
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 4 Dec 2020 (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.
Among subacute stroke patients (within 4 weeks after the onset), patients who are unable to walk are divided into experimental groups and control groups, and conventional rehabilitation treatment including physical therapy and occupational therapy is performed for 4 weeks or more in all groups.
Robot assisted inclined bed treatment and FES were performed, and the control group performed conventional inclined bed treatment.
The purpose of this study is to investigate the effect of robot-assisted inclined bed treatment by tracking observation and comparative analysis of the lower limb function, gait ability, bone density and muscle mass of each group.
Patients appropriate for the selection criteria are divided into experimental group and control group in random permuted blocks to conduct the study. In the experimental group, FES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks, and the control group performed conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week. Separately from this in all groups, functional electrical stimulation treatment is performed once a day in the area except the lower extremities. In addition, all patients receive palliative physical therapy for 4 weeks for 1 hour a day. All subjects undergo a physical examination and whole body composition assessment before and after 4 weeks of treatment, and f/u after 4 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Robot assisted inclined bed treatment and FESRobot assisted inclined bed treatment and FES |
| Control group | Active comparator | Device: conventional inclined bed treatmentconventional inclined bed treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients within 4 weeks of onset of first stroke
- Patients with an FAC score of 1 or less and at least one lower limb FMA of 15 or less
- Adult male or female over 50 years of age
- Those who have consented in writing to this clinical trial
- A person who understands the purpose of the clinical trial and can adapt well to the treatment process
Key exclusion criteria (9 listed)
- Those with lower motor neuron lesions
- A person who has an artificial implant due to a fracture of the lower extremity and spine, or a metal implant that generates an electrical signal such as an artificial pacemaker.
- Those with a history of bone metabolism related diseases such as thyroid or parathyroid disease (excluding osteopenia and osteoporosis) or bone tumor
- A person who has a history of fracture at the site of bone mineral density (ex. L1-L5, femoral head)
- Those who have skin ulcers or skin diseases such as open wounds that make it difficult to apply robotic therapy
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 |
|---|---|---|
| Robot assisted inclined bed treatment and FESFES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks. | Device | Intervention group |
| conventional inclined bed treatmentconventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week | Device | Control group |
Primary outcome
Fugl-Meyer Assessment (lower)
Time frame: before intervention
A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.
Fugl-Meyer Assessment (lower)
Time frame: 4weeks after
A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.
Fugl-Meyer Assessment (lower)
Time frame: 8weeks after
A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.
Motricity Index
Time frame: before intervention
A tool used to evaluate motor power.
Motricity Index
Time frame: 4weeks after
A tool used to evaluate motor power.
Motricity Index
Time frame: 8weeks after
A tool used to evaluate motor power.
FAC (Functional ambulatory scale)
Time frame: before intervention
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
FAC (Functional ambulatory scale)
Time frame: 4weeks after
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
FAC (Functional ambulatory scale)
Time frame: 8weeks after
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
Locomotion level of FIM (functional independence measure)
Time frame: before intervention
Indicator to evaluate independence in performing daily life movements
Locomotion level of FIM (functional independence measure)
Time frame: 4weeks after
Indicator to evaluate independence in performing daily life movements
Locomotion level of FIM (functional independence measure)
Time frame: 8weeks after
Indicator to evaluate independence in performing daily life movements
Berg balance scale
Time frame: before intervention
A tool to evaluate balance
Berg balance scale
Time frame: 4weeks after
A tool to evaluate balance
Berg balance scale
Time frame: 8weeks after
A tool to evaluate balance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
The AHA Oneida Study
Oneida Nation Members
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Active, not recruiting
Brain Connectivity Analysis
Neural Injury
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.
Deog Young Kim principal investigator
Severance 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 Robot assisted inclined bed treatment and FES and conventional inclined bed treatment in people with Stroke, run by Yonsei University 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 5 inclusion and 9 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 4 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deog Young Kim (82-2-2228-3700, kimdy@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (lower) (time frame: before intervention). The study lists 15 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 4 Dec 2020.