Stroke, IschemicNCT04287231
The Effect of The Five-Session Dual-tDCS On Lower-Limb Performance in Sub-Acute Stroke
A study testing Transcranial direct current stimulation in people with Stroke, Ischemic, run by Mahidol University at 1 site in Thailand.
Trial summary
The aim of the present study is to determine the effect of the five-session dual-tDCS combine with physical therapy on gait performance, balance and lower limbs muscle strength in patients with subacute stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 19 Aug 2019to 31 Jul 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range 20-75 years
- First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. Diagnostic confirmation will be performed by CT scan or MRI
- Sub-acute onset (1-6 months after the stroke onset)
- Able to walk without physical assistance at least 6 meters
Who cannot join
- All subjects will be excluded from the study if they have:
- Not cooperative or cannot understand the instruction
- Clinical unstable such as vital sign unstable (systolic blood pressure (SBP) ≥ 185 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg (98) and resting heart rate averaging ≥ 100 bpm (99))
- No clear neurological antecedent history or psychiatric disorder
- Moderate pain in any joint of both lower limb (Pain Scale (VAS) ≥ 4/10)
- Unstable medical conditions such as being in the middle of changing medical treatment.
- Condition that may increase the risk of stimulation such as epilepsy, pregnancy, unexplained headaches, intracranial metal, pacemaker (evaluating by subjective examination).
- Participate in the other protocol or receive alternative treatment such as transcranial magnetic stimulation within 1 month.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Physical Therapy, Mahidol University
Salaya, Nakonpathom, 73170
About this study
Official title: The Effect of The Five-Session Dual-Transcranial Direct Current Stimulation on Lower-Limb Performance In Sub-Acute Stroke
The aim of the present study is to determine the effect of the five-session dual-tDCS combine with physical therapy on gait performance, balance and lower limbs muscle strength in patients with subacute stroke.
Read the detailed description
Stroke is a leading cause of long term disability. The recovery of motor function after stroke is often incomplete, despite classical rehabilitation techniques. In the beginning of the 21st century, transcranial direct current stimulation (tDCS) was introduced as a non-invasive tool to reversibly modulate brain excitability in humans in which a device sends constant low direct current (DC) delivered to the area of interest through the electrodes. Transcranial direct current stimulation (tDCS) has been used in neurorehabilitation to benefit ischemic stroke patients at different stage of stroke especially during acute, sub-acute and chronic phase with positive and safety reports.
After stroke, the excitability of the lesioned hemisphere is decreased and seen like overactive of the excitability of non-lesioned hemisphere. Abnormally high interhemispheric inhibition (IHI) drive from intact to lesioned hemisphere has been reported. The neural plasticity begins in early stages after stroke. Prevent the imbalance IHI and increase the excitability of the lesioned hemisphere in the early phase would be a beneficial for stroke rehabilitation.
Based on the polarity-specific effects, anodal tDCS increases cortical excitability and cathodal tDCS decreases cortical excitability. Transcranial direct current stimulation (tDCS) can be applied in two distinct montages: monocephalic and bi-hemispheric/dual-tDCS (applying two electrodes over both cerebral hemispheres at the same time). To induce post-stroke motor recovery, two different monocephalic montages are typically used: i) to restore excitability in the lesioned hemisphere: anode over the lesioned hemisphere and the cathode as the reference electrode placed over the contra-orbital area ii) to down regulate excitability of the non-lesioned hemisphere and rebalance IHI: cathode over the non-lesioned hemisphere and the anode as the reference electrode. Dual-tDCS can be also applied, permitting simultaneous coupling of excitatory and inhibitory effects on both cortices. There are few evidences showing that tDCS (monocephalic and bi-hemispheric/dual-tDCS) could improve lower limb performance at immediate and at least 3 months. However, there is still unclear effect on gait performance and muscle strength.
Recently, dual-hemisphere tDCS, in which, excites one hemisphere using anodal stimulation and inhibits the other by cathodal stimulation has been described in healthy volunteers to greater enhance hand motor learning compared to uni-hemispheric tDCS. The corresponding tDCS-induced changes were reported in imaging study to involve interhemispheric interactions.
Dual-tDCS has been more recent used in rehabilitation aiming to reduce the inhibition exerted by the non-lesioned hemisphere on the lesioned hemisphere and restore the normal balance of the IHI. Dual-tDCS combined with training or simultaneous occupational/physical therapy has been reported to improve motor skill learning and functions of the paretic upper limb in chronic stroke patients.
Lower-limb functions are commonly disabling after stoke, however, less studies have focused the effect of tDCS on lower limb functions. A single session of anodal tDCS over the lower limb M1 has reported to acutely enhance the effect of motor practice of the paretic ankle, force production of the paretic knee extensors, and postural stability in chronic stroke patients. A study showed an improvement of walking speed immediately after a single session of dual-tDCS alone in sub-acute stroke patients .
Based on the previous study, 1-2 mA current intensity of tDCS is usually used for modulating brain activity. The proper current density delivered is between 0.029-0.008 mA/cm 2. The higher current density, the longer lasting, stronger, and deeper cortical neuron stimulation. Therefore, 2 mA current intensity of tDCS was applied in stroke patients for lower limb performance improvement. Following homologous brain regions, the motor area of lower extremities is in depth and previous studies demonstrated that current intensity 2 mA of tDCS could pass through the lower extremities area of the brain.
Moreover, Tahtis et al, 2013 found that using 2 mA of dual-tDCS could improve walking speed immediately after a single session in sub-acute stroke and Klomjai et al, 2018 found that a single session of dual-tDCS 2 mA with physical therapy in sub-acute stroke immediately improved sit to stand performance greater than physical therapy alone. The mechanisms of actions was hypothesized that when stimulation continuously has effect on neuronal plasticity changes. Therefore, they suggested that further study shall implement more sessions of dual-tDCS combined with physical therapy to improve lower limb performance and determine the long lasting-after effect.
The effect of 5-consecutive sessions dual-tDCS during physical therapy on upper limb performance showed significant improvement of upper limb motor functions and maintained at least 1 week. In this study, long-lasting effect was demonstrated at least one week to three months. There are evidences that 5 consecutive days of uni-hemisphere tDCS appeared to improve lower limb motor functions without serious adverse effects in patients with stroke.It is still unclear for the effect of multiple sessions of dual-tDCS on gait performance and muscle strength as well as the long lasting after-effect of multiple sessions of dual-tDCS.
Therefore, the aim of the present study is to investigate the efficacy of 5 consecutive sessions of dual-tDCS combined with conventional physical therapy on the lower limb functions after stroke in sub-acute. Clinical outcomes for lower limb performance evaluations will consist of muscle strength assessed by hand-held dynamometer, the Time up and go test for lower limb functional performance, Five times sit to stand test for dynamic balance and muscle strength, and the Zebris Force distribution measurement (FDM) for gait analysis.
- Conditions
- Stroke, Ischemic
- Being tested
- Transcranial direct current stimulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
This instrument will be used to induce post-stroke motor recovery, two different monocephalic montages are typically used to restore excitability in the lesioned hemisphere and to down regulate excitability of the non-lesioned hemisphere and rebalance Interhemispheric inhibition. each participant will undergo a 20-minute period of tDCS, applied at 2 mA through a pair of saline-soaked surface sponge electrodes (35 cm2).
| Study group | Role | What they receive |
|---|---|---|
| Dual-tDCS & PT | Experimental | Dual tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere for 20 mins before physical therapy (about 1 hours). Current intensity is fixed at 2 mA and current will flow continuously. Physical therapist will give an intervention program for lower limb performence. Receives: Device: Transcranial direct current stimulation |
| Sham-tDCS & PT | Active comparator | Sham tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere, current intensity will be 2mA (sham mode). Physical therapist will give an intervention program for lower limb performence. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany)
Force distribution measurement (FDM) will be used to analyze gait cycle. The platform will be detecting the force and weight bearing when foot's patients contact the platform and calculate gait parameter.
This system was used to analyze gait cycle (step length in cm, step time in second, speed in km/h and cadence in step/minute).
Participants walked 3 meter per trial on platform and assessed 5 times. The result was selected from average five trials. Participants can rest between trials about 2 minutes or as long as they desired to avoid fatigue.
Measured: 15 minutes
Timed-up and go test (TUG)
The Timed-up \& Go (TUG) test is a simple and quick functional mobility test that requires a subject to stand up, walk 3 m, turn, walk back, and sit down.
The objective of TUG is to determine fall risk and measure the progress of balance, sit to stand, and walking.
This test was initially designed for elderly persons, but is used for people with Parkinson, stroke, Alzheimer, CVA, Huntington disease and others
The TUG were assessed only 1 trial and participant were performed as comfortable speed. Materials of TUG are One chair with armrest, stopwatch, tape (to mark 3 meters). The patient starts in a seated position. After that the patient stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated and the subject is allowed to use an assistive device. Be sure to document the assistive device used.
Measured: 5 minutes
Five Times Sit to Stand Test (FTSTS)
The FTSTS measures the functional strength of the lower limbs. Subjects sat with their arms folded across the chest and their back against the chair's backrest. They were asked to stand up fully and sit down again 5 times as quickly as possible. The test was repeated 3 times
The Five-Times-Sit-to-Stand test (FTSTS) is a clinical test that explores postural control and lower limb muscular strength, devised to accommodate patients who can perform the sit-to-stand activity at least five times. As such, it is a test helpful in quantifying a daily transitional movement while also helping to assess fall risk and disability
The FTSTS were assessed 2 times and selected score of the best trial. Participants can rest between trials about 2 minutes or as long as they desire to avoid fatigue.
Measured: 5 minutes
Secondary outcomes (1)
Hand-held dynamometer (HHD)
The HHD measures the muscle strength. The HHD is simple, quantitative evaluation and widely used for measurement of muscle strength.
The strength of lower limbs (hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor) were assessed by using the hand-held dynamometer.
The strength of lower limbs included hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor were assessed by using the hand-held dynamometer. Hip flexor,ankle dorsiflexor and ankle plantarflexor was assessed in supine position, knee extensor was assessed in sitting position, hip extensor and knee flexor were assessed in prone position and hip abductor was assessed in side lying position. Each muscle was assessed 2 times and selected score of the best trial. Participants can rest between trials about 1 minute or as long as they desired to avoid fatigue.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start19 Aug 2019
- Primary completion31 Mar 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanalee Klomjai, PhD, Study director, MU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287231
- Sponsor's protocol ID
- MU-CIRB 2019/045.1102.1
- Status last verified
- Dec 2020
- First submitted
- 9 Jan 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Five-Session Dual-Transcranial Direct Current Stimulation on Lower-Limb Performance In Sub-Acute Stroke
- ClinicalTrials.gov ID
- NCT04287231
- Acronym / sponsor ID
- MU-CIRB 2019/045.1102.1
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 27 Feb 2020 (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.
The aim of the present study is to determine the effect of the five-session dual-tDCS combine with physical therapy on gait performance, balance and lower limbs muscle strength in patients with subacute stroke.
Detailed description
Stroke is a leading cause of long term disability. The recovery of motor function after stroke is often incomplete, despite classical rehabilitation techniques. In the beginning of the 21st century, transcranial direct current stimulation (tDCS) was introduced as a non-invasive tool to reversibly modulate brain excitability in humans in which a device sends constant low direct current (DC) delivered to the area of interest through the electrodes. Transcranial direct current stimulation (tDCS) has been used in neurorehabilitation to benefit ischemic stroke patients at different stage of stroke especially during acute, sub-acute and chronic phase with positive and safety reports.
After stroke, the excitability of the lesioned hemisphere is decreased and seen like overactive of the excitability of non-lesioned hemisphere. Abnormally high interhemispheric inhibition (IHI) drive from intact to lesioned hemisphere has been reported. The neural plasticity begins in early stages after stroke. Prevent the imbalance IHI and increase the excitability of the lesioned hemisphere in the early phase would be a beneficial for stroke rehabilitation.
Based on the polarity-specific effects, anodal tDCS increases cortical excitability and cathodal tDCS decreases cortical excitability. Transcranial direct current stimulation (tDCS) can be applied in two distinct montages: monocephalic and bi-hemispheric/dual-tDCS (applying two electrodes over both cerebral hemispheres at the same time). To induce post-stroke motor recovery, two different monocephalic montages are typically used: i) to restore excitability in the lesioned hemisphere: anode over the lesioned hemisphere and the cathode as the reference electrode placed over the contra-orbital area ii) to down regulate excitability of the non-lesioned hemisphere and rebalance IHI: cathode over the non-lesioned hemisphere and the anode as the reference electrode. Dual-tDCS can be also applied, permitting simultaneous coupling of excitatory and inhibitory effects on both cortices. There are few evidences showing that tDCS (monocephalic and bi-hemispheric/dual-tDCS) could improve lower limb performance at immediate and at least 3 months. However, there is still unclear effect on gait performance and muscle strength.
Recently, dual-hemisphere tDCS, in which, excites one hemisphere using anodal stimulation and inhibits the other by cathodal stimulation has been described in healthy volunteers to greater enhance hand motor learning compared to uni-hemispheric tDCS. The corresponding tDCS-induced changes were reported in imaging study to involve interhemispheric interactions.
Dual-tDCS has been more recent used in rehabilitation aiming to reduce the inhibition exerted by the non-lesioned hemisphere on the lesioned hemisphere and restore the normal balance of the IHI. Dual-tDCS combined with training or simultaneous occupational/physical therapy has been reported to improve motor skill learning and functions of the paretic upper limb in chronic stroke patients.
Lower-limb functions are commonly disabling after stoke, however, less studies have focused the effect of tDCS on lower limb functions. A single session of anodal tDCS over the lower limb M1 has reported to acutely enhance the effect of motor practice of the paretic ankle, force production of the paretic knee extensors, and postural stability in chronic stroke patients. A study showed an improvement of walking speed immediately after a single session of dual-tDCS alone in sub-acute stroke patients .
Based on the previous study, 1-2 mA current intensity of tDCS is usually used for modulating brain activity. The proper current density delivered is between 0.029-0.008 mA/cm 2. The higher current density, the longer lasting, stronger, and deeper cortical neuron stimulation. Therefore, 2 mA current intensity of tDCS was applied in stroke patients for lower limb performance improvement. Following homologous brain regions, the motor area of lower extremities is in depth and previous studies demonstrated that current intensity 2 mA of tDCS could pass through the lower extremities area of the brain.
Moreover, Tahtis et al, 2013 found that using 2 mA of dual-tDCS could improve walking speed immediately after a single session in sub-acute stroke and Klomjai et al, 2018 found that a single session of dual-tDCS 2 mA with physical therapy in sub-acute stroke immediately improved sit to stand performance greater than physical therapy alone. The mechanisms of actions was hypothesized that when stimulation continuously has effect on neuronal plasticity changes. Therefore, they suggested that further study shall implement more sessions of dual-tDCS combined with physical therapy to improve lower limb performance and determine the long lasting-after effect.
The effect of 5-consecutive sessions dual-tDCS during physical therapy on upper limb performance showed significant improvement of upper limb motor functions and maintained at least 1 week. In this study, long-lasting effect was demonstrated at least one week to three months. There are evidences that 5 consecutive days of uni-hemisphere tDCS appeared to improve lower limb motor functions without serious adverse effects in patients with stroke.It is still unclear for the effect of multiple sessions of dual-tDCS on gait performance and muscle strength as well as the long lasting after-effect of multiple sessions of dual-tDCS.
Therefore, the aim of the present study is to investigate the efficacy of 5 consecutive sessions of dual-tDCS combined with conventional physical therapy on the lower limb functions after stroke in sub-acute. Clinical outcomes for lower limb performance evaluations will consist of muscle strength assessed by hand-held dynamometer, the Time up and go test for lower limb functional performance, Five times sit to stand test for dynamic balance and muscle strength, and the Zebris Force distribution measurement (FDM) for gait analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-tDCS & PT | Experimental | Device: Transcranial direct current stimulationDual tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere for 20 mins before physical therapy (about 1 hours). Current intensity is fixed at 2 mA and current will flow continuously. Physical therapist will give an intervention program for lower limb performence. |
| Sham-tDCS & PT | Active comparator | Device: Transcranial direct current stimulationSham tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere, current intensity will be 2mA (sham mode). Physical therapist will give an intervention program for lower limb performence. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range 20-75 years
- First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. Diagnostic confirmation will be performed by CT scan or MRI
- Sub-acute onset (1-6 months after the stroke onset)
- Able to walk without physical assistance at least 6 meters
Key exclusion criteria (8 listed)
- All subjects will be excluded from the study if they have:
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 |
|---|---|---|
| Transcranial direct current stimulationThis instrument will be used to induce post-stroke motor recovery, two different monocephalic montages are typically used to restore excitability in the lesioned hemisphere and to down regulate excitability of the non-lesioned hemisphere and rebalance Interhemispheric inhibition. each participant will undergo a 20-minute period of tDCS, applied at 2 mA through a pair of saline-soaked surface sponge electrodes (35 cm2). | Device | Dual-tDCS & PT, Sham-tDCS & PT |
Primary outcome
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany)
Time frame: 15 minutes
Force distribution measurement (FDM) will be used to analyze gait cycle. The platform will be detecting the force and weight bearing when foot's patients contact the platform and calculate gait parameter. This system was used to analyze gait cycle (step length in cm, step time in second, speed in km/h and cadence in step/minute). Participants walked 3 meter per trial on platform and assessed 5 times. The result was selected from average five trials. Participants can rest between trials about 2 minutes or as long as they desired to avoid fatigue.
Timed-up and go test (TUG)
Time frame: 5 minutes
The Timed-up \& Go (TUG) test is a simple and quick functional mobility test that requires a subject to stand up, walk 3 m, turn, walk back, and sit down. The objective of TUG is to determine fall risk and measure the progress of balance, sit to stand, and walking. This test was initially designed for elderly persons, but is used for people with Parkinson, stroke, Alzheimer, CVA, Huntington disease and others The TUG were assessed only 1 trial and participant were performed as comfortable speed. Materials of TUG are One chair with armrest, stopwatch, tape (to mark 3 meters). The patient starts in a seated position. After that the patient stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated and the subject is allowed to use an assistive device. Be sure to document the assistive device used.
Five Times Sit to Stand Test (FTSTS)
Time frame: 5 minutes
The FTSTS measures the functional strength of the lower limbs. Subjects sat with their arms folded across the chest and their back against the chair's backrest. They were asked to stand up fully and sit down again 5 times as quickly as possible. The test was repeated 3 times The Five-Times-Sit-to-Stand test (FTSTS) is a clinical test that explores postural control and lower limb muscular strength, devised to accommodate patients who can perform the sit-to-stand activity at least five times. As such, it is a test helpful in quantifying a daily transitional movement while also helping to assess fall risk and disability The FTSTS were assessed 2 times and selected score of the best trial. Participants can rest between trials about 2 minutes or as long as they desire to avoid fatigue.
1 secondary outcome
Hand-held dynamometer (HHD)
Time frame: 15 minutes
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 11 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Wanalee Klomjai, PhD study director
MU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Stroke, Ischemic, run by Mahidol University at 1 site in Thailand.
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 8 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 11 Dec 2020. 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 Thailand. 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?
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) (time frame: 15 minutes). The study lists 3 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 11 Dec 2020.