StrokeNCT02680691
Robot Assisted Gait Training in Patients With Infratentorial Stroke
A study testing Robot, then conventional training and Conventional, then robot training in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robot, then conventional training and Conventional, then robot training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with infratentorial stroke
- Cognitively intact enough to understand and follow the instructions from the investigator
Who cannot join
- chronic neurological pathology
- orthopedic injuries
- femur lengths of less than 34cm
- severely limited range of lower extremity joint motion
- medical instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke
The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke
Read the detailed description
The hypothesis is to determine the robotic gait training would be better than conventional therapy regarding the postural balance.
- Conditions
- Stroke
- Being tested
- Robot, then conventional training, Conventional, then robot training
- Keywords
- infratentorial stroke, robot, postural balance, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot, then conventional trainingOther
Robot assisted gait training from the baseline, then conventional gait training at 4 weeks after baseline
Conventional, then robot trainingOther
Conventional gait training from the baseline, then robot assisted gait training at 4 weeks after baseline
| Study group | Role | What they receive |
|---|---|---|
| Robot, then conventional training | Experimental | Robot assisted gait training 4 weeks after conventional gait training Receives: Other: Robot, then conventional training |
| Conventional, then robot training | Active comparator | Conventional gait training 4 weeks after robot assisted gait training Receives: Other: Conventional, then robot training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Berg Balance Scale at 4 Weeks
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life
Measured: Baseline and 4 weeks from baseline
Secondary outcomes (8)
Berg Balance Scale
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Trunk impairment scale
Trunk impairment scale performs to evaluate the sitting balance and trunk control ability examining static sitting balance, dynamic sitting balance, and coordination
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Functional Ambulation Category
Categorizes patients according to basic motor skills necessary for functional ambulation. It represents the status of ambulation
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from 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, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Fugl-Meyer Assessment
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Korean version of Falls efficacy scale
Asseses perception of balance and stability during activities of daily living Assesses fear of falling in the elderly population
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Scale for the assessment and rating of ataxia
Scale for the assessment and rating for infratentorial stroke
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Balance test using force plate
Each subject performs the following four tasks resembling Romberg test: standing with their feet positioning with the distance between their shoulders with eyes open (FSEO) or closed (FSEC), and standing with their feet together with eyes open (FTEO) or closed (FTEC). Each task is performed for 20 seconds and repeat for three times.
Measured: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Outcomes assessor
- Enrolment
- 19 participants (actual)
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
- NCT02680691
- Sponsor's protocol ID
- NRC-2015-01-002
- Status last verified
- Mar 2018
- First submitted
- 9 Feb 2016
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim HY, Shin JH, Yang SP, Shin MA, Lee SH. Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial. J Neuroeng Rehabil. 2019 Jul 29;16(1):99. doi: 10.1186/s12984-019-0553-5.
PubMed 31358017
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke
- ClinicalTrials.gov ID
- NCT02680691
- Acronym / sponsor ID
- NRC-2015-01-002
- Conditions
- Stroke
- Keywords
- infratentorial stroke, robot, postural balance, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Feb 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 Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke
Detailed description
The hypothesis is to determine the robotic gait training would be better than conventional therapy regarding the postural balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot, then conventional training | Experimental | Other: Robot, then conventional trainingRobot assisted gait training 4 weeks after conventional gait training |
| Conventional, then robot training | Active comparator | Other: Conventional, then robot trainingConventional gait training 4 weeks after robot assisted gait training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with infratentorial stroke
- Cognitively intact enough to understand and follow the instructions from the investigator
Key exclusion criteria (5 listed)
- chronic neurological pathology
- orthopedic injuries
- femur lengths of less than 34cm
- severely limited range of lower extremity joint motion
- medical instability
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, then conventional trainingRobot assisted gait training from the baseline, then conventional gait training at 4 weeks after baseline | Other | Robot, then conventional training |
| Conventional, then robot trainingConventional gait training from the baseline, then robot assisted gait training at 4 weeks after baseline | Other | Conventional, then robot training |
Primary outcome
Change From Baseline in Berg Balance Scale at 4 Weeks
Time frame: Baseline and 4 weeks from baseline
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life
8 secondary outcomes
Berg Balance Scale
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Trunk impairment scale
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Functional Ambulation Category
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
10m walk test
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Fugl-Meyer Assessment
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Korean version of Falls efficacy scale
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Scale for the assessment and rating of ataxia
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Balance test using force plate
Time frame: Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
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 5 Mar 2018.
- Derived from this study: PubMed 31358017Kim HY, Shin JH, Yang SP, Shin MA, Lee SH. Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial. J Neuroeng Rehabil. 2019 Jul 29;16(1):99. doi: 10.1186/s12984-019-0553-5.
- Site of the present studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Robot, then conventional training and Conventional, then robot training 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 5 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 5 Mar 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 From Baseline in Berg Balance Scale at 4 Weeks (time frame: Baseline and 4 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02680691, which also lists 1 linked publication.
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 5 Mar 2018.