StrokeNCT01781689
The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients
A study testing Functional Electric Stimulation and Rehabilitation programs in people with Stroke, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Stroke is the most common cause of motor function impairment. However, the functional impairment is not totally irreversible. Several mechanisms may involved in both the cortical and motor function recovery after onset of stroke, and most of them are related to changes of cortical perfusion and metabolism. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Functional Electric Stimulation and Rehabilitation programs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2012to 1 Aug 2019
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ischemic stroke(unilateral, onset within 7 days, without previous stroke history)
- Vital sign stable
- Upper extremity motor function impairment(brunnström stage I~III)
Who cannot join
- with pacemakers
- Seizure history
- Serious dysrhythmias
- Poor cognition function(MMSE<13)
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is the most common cause of motor function impairment. However, the functional impairment is not totally irreversible. Several mechanisms may involved in both the cortical and motor function recovery after onset of stroke, and most of them are related to changes of cortical perfusion and metabolism.
Motor function recovery after stroke (especially middle cerebral artery territory lesion) frequently follow stereotypic pattern (brunnström stage).
This study is designed to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage after stroke.
Read the detailed description
Participants receive evaluations (1/week for 3 months period) of
- motor function (Include: MMSE, brunnström stage, Fugl-Meyer Assessment of Physical Performance, Box and Block Test of Manual Dexterity, Functional Independence Measure)
- cortical perfusion detection during performing limb movements (using NIRS)
Then use path analysis to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke.
- Conditions
- Stroke
- Being tested
- Functional Electric Stimulation, Rehabilitation programs
- Keywords
- cortical activation, motor function, activity of daily living
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electric StimulationProcedure or surgery
apply to the hemiplegia affected limbs, helping movement
Rehabilitation programsOther
include occupational therapy and physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Functional Electric Stimulation | Experimental | perform arm cranking with functional electrical stimulation Receives: Procedure: Functional Electric Stimulation |
| traditional rehabilitation program | Sham comparator | Receive traditional rehabilitation programs Receives: Other: Rehabilitation programs |
| Health | No intervention | with no motor function impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical activation
Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months
Measured: weekly changes within 3 months
Secondary outcomes (1)
motor function
assess motor function every week for 3 months
Measured: weekly changes within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startOct 2012
- Primary completion1 Jul 2019
- Study completion1 Aug 2019
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng-Yu Hoe, MD., PhD., Kaohsiung Veterans General Hospital.
- Investigators
- Zheng-Yu Hoe, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781689
- Sponsor's protocol ID
- VGHKS102-086
- Other IDs
- VGHKS12-CT7-07
- Status last verified
- Oct 2023
- First submitted
- 27 Jan 2013
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients
- ClinicalTrials.gov ID
- NCT01781689
- Acronym / sponsor ID
- VGHKS102-086
- Conditions
- Stroke
- Keywords
- cortical activation, motor function, activity of daily living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Oct 2012
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 1 Feb 2013 (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.
Stroke is the most common cause of motor function impairment. However, the functional impairment is not totally irreversible. Several mechanisms may involved in both the cortical and motor function recovery after onset of stroke, and most of them are related to changes of cortical perfusion and metabolism.
Motor function recovery after stroke (especially middle cerebral artery territory lesion) frequently follow stereotypic pattern (brunnström stage).
This study is designed to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage after stroke.
Detailed description
Participants receive evaluations (1/week for 3 months period) of
- motor function (Include: MMSE, brunnström stage, Fugl-Meyer Assessment of Physical Performance, Box and Block Test of Manual Dexterity, Functional Independence Measure)
- cortical perfusion detection during performing limb movements (using NIRS)
Then use path analysis to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functional Electric Stimulation | Experimental | Procedure: Functional Electric Stimulationperform arm cranking with functional electrical stimulation |
| traditional rehabilitation program | Sham comparator | Other: Rehabilitation programsReceive traditional rehabilitation programs |
| Health | No intervention | –with no motor function impairment |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemic stroke(unilateral, onset within 7 days, without previous stroke history)
- Vital sign stable
- Upper extremity motor function impairment(brunnström stage I~III)
Key exclusion criteria (4 listed)
- with pacemakers
- Seizure history
- Serious dysrhythmias
- Poor cognition function(MMSE<13)
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 Electric Stimulationapply to the hemiplegia affected limbs, helping movement | Procedure or surgery | Functional Electric Stimulation |
| Rehabilitation programsinclude occupational therapy and physical therapy | Other | traditional rehabilitation program |
Primary outcome
Cortical activation
Time frame: weekly changes within 3 months
Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months
1 secondary outcome
motor function
Time frame: weekly changes within 3 months
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 4 Oct 2023.
Related trials for Stroke
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Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
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Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
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Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
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Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
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.
Zheng-Yu Hoe principal investigator
Kaohsiung Veterans General 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 Functional Electric Stimulation and Rehabilitation programs in people with Stroke, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 3 inclusion and 4 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 4 Oct 2023. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Cortical activation (time frame: weekly changes within 3 months). 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 Oct 2023.