Incomplete Spinal Cord InjuryNCT04910412
Effects of tDCS With Gait Training on Leg Performance in Incomplete Spinal Cord Injury
A study testing transcranial direct current stimulation in people with Incomplete Spinal Cord Injury, run by Mahidol University at 1 site in Thailand.
Trial summary
This study aim to investigate the effects of anodal transcranial direct current stimulation combined with gait training for 5 consecutive session on gait performance, balance, sit to stand performance and quality of life in persons with incomplete SCI at post intervention, 1-month follow-up and 2-month follow up Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Incomplete Spinal Cord Injury
- 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
- 34 participants
- Where
- 1 siteThailand
- Study dates
- 25 May 2021to 31 May 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Spinal Injury Association (ASIA) impairment scale C or D
- Age between 18-70 years
- Onset of injury between 1-30 months
- Ability to walk at least 15 meters with or without walking aid
Who cannot join
- Using other orthoses except the ankle-foot orthosis (AFO)
- Having musculoskeletal pain limiting their walking (pain score > 5/ 10)
- Modified Ashworth Scale (MAS) greater than 2
- Having unstable cardiopulmonary disease
- Having uncontrolled conditions e.g. uncontrolled hypertension, uncontrolled diabetes
- Having a history of other neurological diseases e.g. stroke
Show all 11Show fewer
- Having contra-indication to use tDCS which are
- The presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker
- Having an open wound or wound infection on the scalp
- Having a history of brain surgery
- Having a history of seizure
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Sirindhorn National Medical Rehabilitation Institute
Nonthaburi, 11000
About this study
Official title: Effects of Transcranial Direct Current Stimulation With Gait Training on Lower Limb Performance in Individual With Incomplete Spinal Cord Injury
This study aim to investigate the effects of anodal transcranial direct current stimulation combined with gait training for 5 consecutive session on gait performance, balance, sit to stand performance and quality of life in persons with incomplete SCI at post intervention, 1-month follow-up and 2-month follow up
Read the detailed description
The result from the previous studies of Water in 1994 regarding the ambulation status of patients with spinal cord injury (SCI) for a period of 1 year after injury. It was found that 76% of incomplete paraplegia and 46 % of incomplete tetraplegia can recovery their walking ability to become community ambulators. However, the recovery rate gradually decreased and started to hit the plateau level around 9 months post injury or in chronic phase. Therefore, it is a challenge in rehabilitation to restore their functions such as walking which is a primary goal of functional independence.
Activity-based rehabilitation therapy (ABRT) (such as locomotion training) is an intensive intervention that has the potential to promote neurological recovery and enhance walking ability in individual with incomplete SCI. Although, ABRT showed positive results in motor function recovery in incomplete SCI survivors, it may not be able to promote full recovery, especially in chronic patients. Recent studies showed that the combination of training with top-down approach may be an option that could promote motor recovery after SCI.
transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that is currently being used as an add-on treatment in neurorehabilitation. tDCS over the primary motor cortex has been shown to modulate neural activity at both cortical and spinal levels. It also produce an after-effect in modulating neuronal synaptic plasticity and increasing the expression of brain-derived neurotrophic factor (BDNF). Early tDCS studies have shown that increasing stimulation intensity or duration within certain limits enhances tDCS efficacy: while anodal stimulation increases cortical excitability, cathodal stimulation decreases it. The application of tDCS is to place the electrode in a specific montage on the decided target brain area and deliver the low-intensity current pass through that brain area for neural modulation during or after providing a rehabilitation program. Previous studies of the application of tDCS showed that applying of tDCS on primary motor cortex with intensity of 2 milliampere (mA) for 10-20 minutes combined with rehabilitation can enhance lower limb performance such as knee strength, ankle movement, and sit to stand performance in people with stroke as well as walking speed in people with Parkinson's disease. According to result from those previous studies can revealed that the combination of rehabilitation with modulation of corticospinal excitability can enhance lower limb performance in individual with neurological condition. In individuals with incomplete SCI, the excitability of the preserved corticospinal pathways is reduced which can affect the control of their motor skills and motor recovery. Several studies reported positive effect of anodal tDCS combined with training in individuals with incomplete SCI, however most of studies focused on upper limb function. Only few studies on the outcome of lower limb function and walking ability, which are required to return to their daily living and thus increase in quality of life (QOL). Moreover, most of studies in the lower limb were conducted in a small sample size and reported inconclusive results.
Therefore, the purpose of this study is to determine whether the effects of combining anodal tDCS with gait training for 5 consecutive session in people with incomplete SCI can improve lower limb performance consist of gait performance(spatiotemporal), dynamic balance(time up and go test), sit to stand performance (5 times of sit to stand test) and QOL after a prolonged period of follow-up at 1-month and 2-month compare to control group of sham tDCS with gait training.
- Conditions
- Incomplete Spinal Cord Injury
- Being tested
- transcranial direct current stimulation
- Keywords
- Transcranial direct current stimulation, Incomplete spinal cord injury, Lower limb performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Transcranial direct current stimulation will be use for the intervention. Anodal and sham tDCS will be applied in 2 mA through a pair of saline-soaked surface sponge electrode 35 cm square for 20 minute over the primary motor area for modulating the cortical excitability before apply the rehabilitation training
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS with gait training | Experimental | Anodal tDCS will be applied over the primary motor cortex (M1) (anodal or active electrode on M1 area, cathodal or reference electrode on supraorbital area) for 20 mins with 2 mA intensity before 50-minute of gait training with external cue and feedback for 5 consecutive sessions Receives: Device: transcranial direct current stimulation |
| Sham tDCS with gait training | Active comparator | Sham tDCS will be applied over the primary motor cortex for 20mins before 50-minute of gait training with external cue and feedback for 5 consecutive sessions Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in gait efficacy assessed by walking speed(m/s) at 5 days
10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.
Measured: Baseline and 5 days
Change from baseline in gait efficacy assessed by walking speed(m/s) at 1 month
10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.
Measured: Baseline and 1 month
Change from baseline in gait efficacy assessed by walking speed (m/s) at 2 months
10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.
Measured: Baseline and 2 months
Secondary outcomes (14)
Change from baseline in gait efficacy assessed by stride parameter (m) at 5 days
G walk accelerometer will be use for measuring stride component of walking with comfortable pace. The assessor will attach the device with belt at L5 spinous process and ask the participants to walk with their comfortable pace and record the parameter then transfer to computer. The increasing of stride length indicates good walking performance. The reducing of stride duration indicates good walking performance.
Measured: Baseline and 5 days
Change from baseline in gait efficacy assessed by stride parameter (m) at 1 month
G walk accelerometer will be use for measuring stride component of walking with comfortable pace. The assessor will attach the device with belt at L5 spinous process and ask the participants to walk with their comfortable pace and record the parameter then transfer to computer. The increasing of stride length indicates good walking performance. The reducing of stride duration indicates good walking performance.
Measured: Baseline and 1 month
Change from baseline in gait efficacy assessed by stride parameter (m) at 2 months
G walk accelerometer will be use for measuring stride component of walking with comfortable pace. The assessor will attach the device with belt at L5 spinous process and ask the participants to walk with their comfortable pace and record the parameter then transfer to computer. The increasing of stride length indicates walking performance. The reducing of stride duration indicates walking performance.
Measured: Baseline and 2 months
Change from baseline in gait efficacy assessed by cadence (step/min) at 5 days
G walk accelerometer will be use for measuring cadence of walking with comfortable pace. The assessor will attach the device with belt at L5 spinous process and ask the participants to walk with their comfortable pace and record the parameter then transfer to computer. The increasing of cadence indicates good walking performance.
Measured: Baseline and 5 days
Change from baseline in gait efficacy assessed by cadence (step/min) at 1 month
G walk accelerometer will be use for measuring cadence of walking with comfortable pace. The assessor will attach the device with belt at L5 spinous process and ask the participants to walk with their comfortable pace and record the parameter then transfer to computer. The increasing of cadence indicates good walking performance.
Measured: Baseline and 1 month
Change from baseline in gait efficacy assessed by cadence (step/min) at 2 months
G walk accelerometer will be use for measuring cadence of walking with comfortable pace. The assessor will attach the device with belt at L5 spinous process and ask the participants to walk with their comfortable pace and record the parameter then transfer to computer. The increasing of cadence indicates good walking performance.
Measured: Baseline and 2 months
Change from baseline in balance efficacy assessed by duration of timed up and go test at 5 days
The timed up and go test will used for assessing dynamic balance of participants by asking the participant to stand up from standard chair with back rest and walk forward for 3 meters and return to sit down at the chair again. The assessor will record the time spending when instructing the participants to start and stop record time when the participants sit down and back against the back rest again. The shorter time indicates good dynamic balance.
Measured: Baseline and 5 days
Change from baseline in balance efficacy assessed by duration of timed up and go test (s) at 1 month
The timed up and go test will used for assessing dynamic balance of participants by asking the participant to stand up from standard chair with back rest and walk forward for 3 meters and return to sit down at the chair again. The assessor will record the time spending when instructing the participants to start and stop record time when the participants sit down and back against the back rest again. The shorter time indicates good dynamic balance.
Measured: Baseline and 1 month
Change from baseline in balance efficacy assessed by duration of timed up and go test (s) at 2 months
The timed up and go test will used for assessing dynamic balance of participants by asking the participant to stand up from standard chair with back rest and walk forward for 3 meters and return to sit down at the chair again. The assessor will record the time spending when instructing the participants to start and stop record time when the participants sit down and back against the back rest again. The shorter time indicates good dynamic balance.
Measured: Baseline and 2 months
Change from baseline in balance efficacy assessed by duration of five time sit to stand test (s) at 5 days
Five time sit to stand test will be used for measuring leg strength and dynamic balance. The assessor will ask the participants to standing up from armless chair with back rest for 5 times in a raw as fast as possible. the assessor will record the time spending of complete 5 time of sit to stand that start from giving instruction and stop when the participant completely sit on chair at 5th repetition. The shorter time indicates good performance
Measured: Baseline and 5 days
Change from baseline in balance efficacy assessed by duration of five time sit to stand test(s) at 1 month
Five time sit to stand test will be used for measuring leg strength and dynamic balance. The assessor will ask the participants to standing up from armless chair with back rest for 5 times in a raw as fast as possible. the assessor will record the time spending of complete 5 time of sit to stand that start from giving instruction and stop when the participant completely sit on chair at 5th repetition. The shorter time indicates good performance
Measured: Baseline and 1 month
Change from baseline in balance efficacy assessed by duration of five time sit to stand test (s) at 2 months
Five time sit to stand test will be used for measuring leg strength and dynamic balance. The assessor will ask the participants to standing up from armless chair with back rest for 5 times in a raw as fast as possible. the assessor will record the time spending of complete 5 time of sit to stand that start from giving instruction and stop when the participant completely sit on chair at 5th repetition. The shorter time indicates good performance
Measured: Baseline and 2 months
Change from baseline in quality of life assessed by WHOQOL-Bref Thai version (score 26-130) at 1 month
World Health Organization (WHO) quality of life (QOL)- bref Thai version will be use for assessing in quality of life. there are two types of questions which are the perceived objective and the self-report subjective and consist of four components of well-being which are physical, psychological, social, and environmental. Each item will be scored from 1-5. (Total score 26-130). The higher score indicates better QOL.
Measured: Baseline and 1 month
Change from baseline in quality of life assessed by WHOQOL-Bref Thai version (score 26-130) at 2 months
WHO quality of life (QOL)- bref Thai version will be use for assessing in quality of life. there are two types of questions which are the perceived objective and the self-report subjective and consist of four components of well-being which are physical, psychological, social, and environmental. Each item will be scored from 1-5 (Total score 26-130). The higher score indicates better QOL.
Measured: Baseline and 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start25 May 2021
- Primary completion30 Apr 2022
- Study completion31 May 2022
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 Incomplete Spinal Cord InjuryStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanalee Klomjai, PhD, Study director, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910412
- Sponsor's protocol ID
- 64005
- Status last verified
- Jun 2022
- First submitted
- 27 May 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klamruen P, Suttiwong J, Aneksan B, Muangngoen M, Denduang C, Klomjai W. Effects of Anodal Transcranial Direct Current Stimulation With Overground Gait Training on Lower Limb Performance in Individuals With Incomplete Spinal Cord Injury. Arch Phys Med Rehabil. 2024 May;105(5):857-867. doi: 10.1016/j.apmr.2023.09.025. Epub 2023 Nov 4.
PubMed 37926224
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation With Gait Training on Lower Limb Performance in Individual With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04910412
- Acronym / sponsor ID
- 64005
- Conditions
- Incomplete Spinal Cord Injury
- Keywords
- Transcranial direct current stimulation, Incomplete spinal cord injury, Lower limb performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 2 Jun 2021 (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 aim to investigate the effects of anodal transcranial direct current stimulation combined with gait training for 5 consecutive session on gait performance, balance, sit to stand performance and quality of life in persons with incomplete SCI at post intervention, 1-month follow-up and 2-month follow up
Detailed description
The result from the previous studies of Water in 1994 regarding the ambulation status of patients with spinal cord injury (SCI) for a period of 1 year after injury. It was found that 76% of incomplete paraplegia and 46 % of incomplete tetraplegia can recovery their walking ability to become community ambulators. However, the recovery rate gradually decreased and started to hit the plateau level around 9 months post injury or in chronic phase. Therefore, it is a challenge in rehabilitation to restore their functions such as walking which is a primary goal of functional independence.
Activity-based rehabilitation therapy (ABRT) (such as locomotion training) is an intensive intervention that has the potential to promote neurological recovery and enhance walking ability in individual with incomplete SCI. Although, ABRT showed positive results in motor function recovery in incomplete SCI survivors, it may not be able to promote full recovery, especially in chronic patients. Recent studies showed that the combination of training with top-down approach may be an option that could promote motor recovery after SCI.
transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that is currently being used as an add-on treatment in neurorehabilitation. tDCS over the primary motor cortex has been shown to modulate neural activity at both cortical and spinal levels. It also produce an after-effect in modulating neuronal synaptic plasticity and increasing the expression of brain-derived neurotrophic factor (BDNF). Early tDCS studies have shown that increasing stimulation intensity or duration within certain limits enhances tDCS efficacy: while anodal stimulation increases cortical excitability, cathodal stimulation decreases it. The application of tDCS is to place the electrode in a specific montage on the decided target brain area and deliver the low-intensity current pass through that brain area for neural modulation during or after providing a rehabilitation program. Previous studies of the application of tDCS showed that applying of tDCS on primary motor cortex with intensity of 2 milliampere (mA) for 10-20 minutes combined with rehabilitation can enhance lower limb performance such as knee strength, ankle movement, and sit to stand performance in people with stroke as well as walking speed in people with Parkinson's disease. According to result from those previous studies can revealed that the combination of rehabilitation with modulation of corticospinal excitability can enhance lower limb performance in individual with neurological condition. In individuals with incomplete SCI, the excitability of the preserved corticospinal pathways is reduced which can affect the control of their motor skills and motor recovery. Several studies reported positive effect of anodal tDCS combined with training in individuals with incomplete SCI, however most of studies focused on upper limb function. Only few studies on the outcome of lower limb function and walking ability, which are required to return to their daily living and thus increase in quality of life (QOL). Moreover, most of studies in the lower limb were conducted in a small sample size and reported inconclusive results.
Therefore, the purpose of this study is to determine whether the effects of combining anodal tDCS with gait training for 5 consecutive session in people with incomplete SCI can improve lower limb performance consist of gait performance(spatiotemporal), dynamic balance(time up and go test), sit to stand performance (5 times of sit to stand test) and QOL after a prolonged period of follow-up at 1-month and 2-month compare to control group of sham tDCS with gait training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS with gait training | Experimental | Device: transcranial direct current stimulationAnodal tDCS will be applied over the primary motor cortex (M1) (anodal or active electrode on M1 area, cathodal or reference electrode on supraorbital area) for 20 mins with 2 mA intensity before 50-minute of gait training with external cue and feedback for 5 consecutive sessions |
| Sham tDCS with gait training | Active comparator | Device: transcranial direct current stimulationSham tDCS will be applied over the primary motor cortex for 20mins before 50-minute of gait training with external cue and feedback for 5 consecutive sessions |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Spinal Injury Association (ASIA) impairment scale C or D
- Age between 18-70 years
- Onset of injury between 1-30 months
- Ability to walk at least 15 meters with or without walking aid
Key exclusion criteria (11 listed)
- Using other orthoses except the ankle-foot orthosis (AFO)
- Having musculoskeletal pain limiting their walking (pain score > 5/ 10)
- Modified Ashworth Scale (MAS) greater than 2
- Having unstable cardiopulmonary disease
- Having uncontrolled conditions e.g. uncontrolled hypertension, uncontrolled diabetes
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 stimulationTranscranial direct current stimulation will be use for the intervention. Anodal and sham tDCS will be applied in 2 mA through a pair of saline-soaked surface sponge electrode 35 cm square for 20 minute over the primary motor area for modulating the cortical excitability before apply the rehabilitation training | Device | Anodal tDCS with gait training, Sham tDCS with gait training |
Primary outcome
Change from baseline in gait efficacy assessed by walking speed(m/s) at 5 days
Time frame: Baseline and 5 days
10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.
Change from baseline in gait efficacy assessed by walking speed(m/s) at 1 month
Time frame: Baseline and 1 month
10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.
Change from baseline in gait efficacy assessed by walking speed (m/s) at 2 months
Time frame: Baseline and 2 months
10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.
14 secondary outcomes
Change from baseline in gait efficacy assessed by stride parameter (m) at 5 days
Time frame: Baseline and 5 days
Change from baseline in gait efficacy assessed by stride parameter (m) at 1 month
Time frame: Baseline and 1 month
Change from baseline in gait efficacy assessed by stride parameter (m) at 2 months
Time frame: Baseline and 2 months
Change from baseline in gait efficacy assessed by cadence (step/min) at 5 days
Time frame: Baseline and 5 days
Change from baseline in gait efficacy assessed by cadence (step/min) at 1 month
Time frame: Baseline and 1 month
Change from baseline in gait efficacy assessed by cadence (step/min) at 2 months
Time frame: Baseline and 2 months
Change from baseline in balance efficacy assessed by duration of timed up and go test at 5 days
Time frame: Baseline and 5 days
Change from baseline in balance efficacy assessed by duration of timed up and go test (s) at 1 month
Time frame: Baseline and 1 month
Change from baseline in balance efficacy assessed by duration of timed up and go test (s) at 2 months
Time frame: Baseline and 2 months
Change from baseline in balance efficacy assessed by duration of five time sit to stand test (s) at 5 days
Time frame: Baseline and 5 days
Change from baseline in balance efficacy assessed by duration of five time sit to stand test(s) at 1 month
Time frame: Baseline and 1 month
Change from baseline in balance efficacy assessed by duration of five time sit to stand test (s) at 2 months
Time frame: Baseline and 2 months
Change from baseline in quality of life assessed by WHOQOL-Bref Thai version (score 26-130) at 1 month
Time frame: Baseline and 1 month
Change from baseline in quality of life assessed by WHOQOL-Bref Thai version (score 26-130) at 2 months
Time frame: Baseline and 2 month
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 22 Jun 2022.
- Derived from this study: PubMed 37926224Klamruen P, Suttiwong J, Aneksan B, Muangngoen M, Denduang C, Klomjai W. Effects of Anodal Transcranial Direct Current Stimulation With Overground Gait Training on Lower Limb Performance in Individuals With Incomplete Spinal Cord Injury. Arch Phys Med Rehabil. 2024 May;105(5):857-867. doi: 10.1016/j.apmr.2023.09.025. Epub 2023 Nov 4.
- 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
Mahidol University
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 Incomplete Spinal Cord Injury, 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 11 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 22 Jun 2022. 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?
Change from baseline in gait efficacy assessed by walking speed(m/s) at 5 days (time frame: Baseline and 5 days). 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?
On the ClinicalTrials.gov record for NCT04910412, 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 22 Jun 2022.