StrokeNCT03991364
Comparison of Robot-assisted Gait Training According to Gait Speed in Participants With Stroke
A study testing Constant gait speed group and Increasing gait speed group in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Comparison of the experimental group that applied the speed of the robot-assisted gait training constantly and the control group that applied the gradual increase of the speed of the robot-assisted gait training. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Constant gait speed group and Increasing gait speed group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2019to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic patients secondary to first cerebrovascular accidents
- Functional ambulation category score ≥ 3
Who cannot join
- History of surgery of affected lower limb
- Fracture of affected lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of the experimental group that applied the speed of the robot-assisted gait training constantly and the control group that applied the gradual increase of the speed of the robot-assisted gait training.
- Conditions
- Stroke
- Being tested
- Constant gait speed group, Increasing gait speed group
- Keywords
- Robot-assisted gait training, stroke, gait speed
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constant gait speed groupOther
The speed of the robot-assisted gait treatment is constantly applied for 5 times a week for 2 weeks.
Increasing gait speed groupOther
The speed of the robot-assisted gait treatment is gradually increase for 5 times a week for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Constant gait speed group | Experimental | experimental group that applied the speed of the robot-assisted gait training constantly Receives: Other: Constant gait speed group |
| Increasing gait speed group | Other | control group that applied the gradual increase of the speed of the robot-assisted gait training Receives: Other: Increasing gait speed group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure (EE)
EE(kcal/min): energy expenditure per minute
Measured: 2 weeks after baseline
Secondary outcomes (11)
Energy expenditure (EE)
EE(kcal/min): energy expenditure per minute
Measured: baseline, 1 weeks after baseline, 3 weeks after baseline
Heart rate (HR)
Cardiac frequency
Measured: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Volume of Oxygen (VO2)
O2 consumption/1min
Measured: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Respiratory Quotient (R)
Respiratory quotient
Measured: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Metabolic equivalent (METS)
the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min
Measured: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
oxygenated hemoglobin (OxyHb)
oxygenated hemoglobin concentration of cortical activation
Measured: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
deoxygenated hemoglobin (DeoxyHb)
deoxygenated hemoglobin concentration of cortical activation
Measured: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Lower extremity Fugl-Meyer Assessment
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity. It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.
Measured: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Functional Ambulation Category
Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device
Measured: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
10m walk test
10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.
Measured: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
timed up and go test
simple test used to assess a person's mobility and requires both static and dynamic balance
Measured: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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.
- 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
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Rehabilitation Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
- Investigators
- Joon-Ho Shin, MS, Principal investigator, National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991364
- Sponsor's protocol ID
- NRC-2019-01-002
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Robot-assisted Gait Training According to Gait Speed in Participants With Stroke
- ClinicalTrials.gov ID
- NCT03991364
- Acronym / sponsor ID
- NRC-2019-01-002
- Conditions
- Stroke
- Keywords
- Robot-assisted gait training, stroke, gait speed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Jun 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.
Comparison of the experimental group that applied the speed of the robot-assisted gait training constantly and the control group that applied the gradual increase of the speed of the robot-assisted gait training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constant gait speed group | Experimental | Other: Constant gait speed groupexperimental group that applied the speed of the robot-assisted gait training constantly |
| Increasing gait speed group | Other | Other: Increasing gait speed groupcontrol group that applied the gradual increase of the speed of the robot-assisted gait training |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hemiplegic patients secondary to first cerebrovascular accidents
- Functional ambulation category score ≥ 3
Key exclusion criteria (2 listed)
- History of surgery of affected lower limb
- Fracture of affected lower limb
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 |
|---|---|---|
| Constant gait speed groupThe speed of the robot-assisted gait treatment is constantly applied for 5 times a week for 2 weeks. | Other | Constant gait speed group |
| Increasing gait speed groupThe speed of the robot-assisted gait treatment is gradually increase for 5 times a week for 2 weeks. | Other | Increasing gait speed group |
Primary outcome
Energy expenditure (EE)
Time frame: 2 weeks after baseline
EE(kcal/min): energy expenditure per minute
11 secondary outcomes
Energy expenditure (EE)
Time frame: baseline, 1 weeks after baseline, 3 weeks after baseline
Heart rate (HR)
Time frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Volume of Oxygen (VO2)
Time frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Respiratory Quotient (R)
Time frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Metabolic equivalent (METS)
Time frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
oxygenated hemoglobin (OxyHb)
Time frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
deoxygenated hemoglobin (DeoxyHb)
Time frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Lower extremity Fugl-Meyer Assessment
Time frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Functional Ambulation Category
Time frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
10m walk test
Time frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
timed up and go test
Time frame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Joon-Ho Shin, MS principal investigator
National Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constant gait speed group and Increasing gait speed group in people with Stroke, run by National Rehabilitation Center, Seoul, Korea 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 2 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 19 Jun 2019. 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 Joon-Ho Shin, MS (82-2-901-1884, asfreelyas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (EE) (time frame: 2 weeks after baseline). 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 19 Jun 2019.