StrokeNCT03184675
The Effects of Functional Action-Observation Training on Gait Ability in Patients With Chronic Stroke
A study testing Functional action observation training and General action observation training in people with Stroke, run by Inje University.
Trial summary
This study aimed to examine the effects of functional action observation training on gait ability in chronic stroke patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Functional action observation training and General action observation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2017to 30 Jul 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
- diagnosis with stroke through computed tomography or magnetic resonance imaging, more than six months ago.
- determination not to have cognitive disability, based on the score(>24 point) of mini mental state examination-Korea version.
- determination not to have visual abnormalities including the unilateral neglect through the motor-free visual perception test(MVPT)
- ability to independently gait longer than 10m in the room and to keep standing up without help.
Who cannot join
- surgery in the last three months
- participating any other research
About this study
Official title: Main Researcher for the Effects of Functional Action-observation Training on Gait Ability
This study aimed to examine the effects of functional action observation training on gait ability in chronic stroke patients.
- Conditions
- Stroke
- Being tested
- Functional action observation training, General action observation training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional action observation trainingOther
the Four Square Step Test (FSST) performance video for enhancing the dynamic balance and the video including participants' daily activities to increase the gait ability such as walking in a corridor, walking around the hospital, walking to the therapy room, coming out of the ward after opening and closing the door of it, coming in and out of toilet, shifting their blue plate. and bringing something from a refrigerator were produced and watched.
General action observation trainingOther
step 1, looking at the front, while walking comfortably; step 2, looking left and right, while walking; step 3, looking up and down, while walking; step 4, looking at the front, left and right, up and down while walking. After 15 minutes of watching the video, the exercise program with a therapist was conducted to increase the gait ability, for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Functional action observation training | Experimental | Not described Receives: Other: Functional action observation training |
| General action observation training group | Other | Not described Receives: Other: General action observation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
temporal gait variables
gait velocity
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Jun 2017 (estimated)
- Primary completion30 Jul 2017 (estimated)
- Study completion30 Jul 2017 (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do hyun Kim, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184675
- Sponsor's protocol ID
- InjeU 2
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 14 Jun 2017
- 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 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Main Researcher for the Effects of Functional Action-observation Training on Gait Ability
- ClinicalTrials.gov ID
- NCT03184675
- Acronym / sponsor ID
- InjeU 2
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 30 Jul 2017 (estimated)
- Study completion
- 30 Jul 2017 (estimated)
- First posted
- 14 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.
This study aimed to examine the effects of functional action observation training on gait ability in chronic stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional action observation training | Experimental | Other: Functional action observation training |
| General action observation training group | Other | Other: General action observation training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis with stroke through computed tomography or magnetic resonance imaging, more than six months ago.
- determination not to have cognitive disability, based on the score(>24 point) of mini mental state examination-Korea version.
- determination not to have visual abnormalities including the unilateral neglect through the motor-free visual perception test(MVPT)
- ability to independently gait longer than 10m in the room and to keep standing up without help.
Key exclusion criteria (2 listed)
- surgery in the last three months
- participating any other research
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 |
|---|---|---|
| Functional action observation trainingthe Four Square Step Test (FSST) performance video for enhancing the dynamic balance and the video including participants' daily activities to increase the gait ability such as walking in a corridor, walking around the hospital, walking to the therapy room, coming out of the ward after opening and closing the door of it, coming in and out of toilet, shifting their blue plate. and bringing something from a refrigerator were produced and watched. | Other | Functional action observation training |
| General action observation trainingstep 1, looking at the front, while walking comfortably; step 2, looking left and right, while walking; step 3, looking up and down, while walking; step 4, looking at the front, left and right, up and down while walking. After 15 minutes of watching the video, the exercise program with a therapist was conducted to increase the gait ability, for 15 minutes. | Other | General action observation training group |
Primary outcome
temporal gait variables
Time frame: 8 weeks
gait velocity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Functional action observation training and General action observation training in people with Stroke, run by Inje University.
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 4 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
temporal gait variables (time frame: 8 weeks). 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 14 Jun 2017.