StrokeNCT02812472
Treadmill Training With Functional Electric Stimulation After Stroke
A study testing Treadmill training with functional electrical stimulation and Treadmill training without functional electrical stimulation in people with Stroke, run by National Yang Ming Chiao Tung University.
Trial summary
The purpose of this study was to investigate the effects of the treadmill training with functional electric stimulation on sensorimotor cortical reorganization and functional improvement in subjects with chronic stroke. Read more about this study
- Who is it for?
- Ages 40 to 82 years
- Conditions the study is for
- Stroke
- What is being tested?
- Treadmill training with functional electrical stimulation and Treadmill training without functional electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Dec 2008
- 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 40 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of unilateral hemiparesis secondary to cerebrovascular accident with post-onset duration of more than 6 months
- ability to walk independently for at least 6 meters with or without use of walking aids
- ability to follow simple verbal commands or instructions
Who cannot join
- unstable medical conditions
- history of other diseases known to interfere with participation in the study
- past history of a seizure
- history of skin allergy to electrode
- use of a cardiac pacemaker
About this study
Official title: Treadmill Training With Functional Electric Stimulation in Patients With Chronic Stroke
The purpose of this study was to investigate the effects of the treadmill training with functional electric stimulation on sensorimotor cortical reorganization and functional improvement in subjects with chronic stroke.
- Conditions
- Stroke
- Being tested
- Treadmill training with functional electrical stimulation, Treadmill training without functional electrical stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill training with functional electrical stimulationOther
Treadmill training without functional electrical stimulationOther
| Study group | Role | What they receive |
|---|---|---|
| treadmill training with functional electrical stimulation | Experimental | Subjects in the experimental group received additional treadmill training with functional electric stimulation for 25 minutes per session, followed by 5 minutes cool down for 12 sessions. Receives: Other: Treadmill training with functional electrical stimulation |
| treadmill training without functional electrical stimulation | Active comparator | Subjects in the control group received additional treadmill training without functional electric stimulation for 25 minutes per session, followed by 5 minutes cool down for 12 sessions. Receives: Other: Treadmill training without functional electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
N1 latency of somatosensory evoked potential
Measured: Change from baseline at 4 weeks
N1P1 amplitude of somatosensory evoked potential
Measured: Change from baseline at 4 weeks
motor threshold of motor evoked potential
Measured: Change from baseline at 4 weeks
map size of motor evoked potential
Measured: Change from baseline at 4 weeks
Secondary outcomes (5)
Fugl-Meyer Assessment
Measured: Change from baseline at 4 weeks
Motricity Index
Measured: Change from baseline at 4 weeks
Berg Balance Scale
Measured: Change from baseline at 4 weeks
walking speed
Measured: Change from baseline at 4 weeks
Modified-Emory Functional Ambulation Profile
Measures a patient's ability to walk through 5 commonly experienced types of terrain.
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionDec 2008
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 National Yang Ming Chiao Tung 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812472
- Sponsor's protocol ID
- 960053
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treadmill Training With Functional Electric Stimulation in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT02812472
- Acronym / sponsor ID
- 960053
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Jun 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 purpose of this study was to investigate the effects of the treadmill training with functional electric stimulation on sensorimotor cortical reorganization and functional improvement in subjects with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treadmill training with functional electrical stimulation | Experimental | Other: Treadmill training with functional electrical stimulationSubjects in the experimental group received additional treadmill training with functional electric stimulation for 25 minutes per session, followed by 5 minutes cool down for 12 sessions. |
| treadmill training without functional electrical stimulation | Active comparator | Other: Treadmill training without functional electrical stimulationSubjects in the control group received additional treadmill training without functional electric stimulation for 25 minutes per session, followed by 5 minutes cool down for 12 sessions. |
Who may qualify
- Ages
- 40 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of unilateral hemiparesis secondary to cerebrovascular accident with post-onset duration of more than 6 months
- ability to walk independently for at least 6 meters with or without use of walking aids
- ability to follow simple verbal commands or instructions
Key exclusion criteria (5 listed)
- unstable medical conditions
- history of other diseases known to interfere with participation in the study
- past history of a seizure
- history of skin allergy to electrode
- use of a cardiac pacemaker
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 |
|---|---|---|
| Treadmill training with functional electrical stimulation | Other | treadmill training with functional electrical stimulation |
| Treadmill training without functional electrical stimulation | Other | treadmill training without functional electrical stimulation |
Primary outcome
N1 latency of somatosensory evoked potential
Time frame: Change from baseline at 4 weeks
N1P1 amplitude of somatosensory evoked potential
Time frame: Change from baseline at 4 weeks
motor threshold of motor evoked potential
Time frame: Change from baseline at 4 weeks
map size of motor evoked potential
Time frame: Change from baseline at 4 weeks
5 secondary outcomes
Fugl-Meyer Assessment
Time frame: Change from baseline at 4 weeks
Motricity Index
Time frame: Change from baseline at 4 weeks
Berg Balance Scale
Time frame: Change from baseline at 4 weeks
walking speed
Time frame: Change from baseline at 4 weeks
Modified-Emory Functional Ambulation Profile
Time frame: Change from baseline at 4 weeks
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 24 Jun 2016.
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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 Treadmill training with functional electrical stimulation and Treadmill training without functional electrical stimulation in people with Stroke, run by National Yang Ming Chiao Tung 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 3 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 24 Jun 2016. 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?
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?
N1 latency of somatosensory evoked potential (time frame: Change from baseline at 4 weeks). The study lists 4 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 24 Jun 2016.