Ischemic StrokeNCT02209922
The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients
A study testing Transcranial direct current stimulation (tDCS) in people with Ischemic Stroke, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Purpose: The incidence of stroke in low-to-middle income countries is increasing .Balance impairment and falling negatively impact function of stroke patients. Mobility is based on successful postural control and about 30% of individuals with stroke are unable to ambulate without assistance.Transcranial direct current… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Dec 2014to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years; first-ever ischemic stroke; chronic phase of recovery (>6 months); ability to walk 6- meter supported or unsupported; ability to stand at least unsupported for 40-seconds with eyes closed; only ischemic stroke involving middle cerebral artery (MCA) territory confirmed by CT or MRI.
Who cannot join
- Use of any neuro- or psycho-active medications that alters balance; any other neurological conditions or sensory disorders affecting postural control; such as brain tumor, or substance abuse; orthopedic diseases; ongoing/recent (within 3 months) balance rehabilitation.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid Beheshti Univesity of Medical sciences
Tehran, 1616931111
Fariba Yadolahi, MD-MPH-PhD, +989109564012, fariba.yadolahi@sbmu.ac.ir
Fariba Yadolahi, MD-MPH-PhD
About this study
Official title: The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients ( A Randomized Controlled Trial)
Purpose:
The incidence of stroke in low-to-middle income countries is increasing .Balance impairment and falling negatively impact function of stroke patients. Mobility is based on successful postural control and about 30% of individuals with stroke are unable to ambulate without assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor recovery in neurological disease.This can be addressed through a tDCS intervention.
Read more
Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on postural control in chronic stroke patients using laboratory and clinical assessments. The following essential treatment components; a) active tDCS stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance training program.
To identify combinations effects of tDCS stimulation plus balance training . Hypothesis: Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will significantly improve stroke clients' balance and functional mobility.
Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions
Experimental: Arm 1
tDCS brain stimulation and simultaneous balance training
Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days.
No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance training
Read the detailed description
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days, All outcome measures will be measured in 4 time points: pre-test, post-test after 10 sessions of intervention, and after 1 week and 1 months post intervention as follow ups.
- Conditions
- Ischemic Stroke
- Being tested
- Transcranial direct current stimulation (tDCS), Sham
- Keywords
- tDCS, stroke, postural control
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
ShamDevice
During sham stimulation, the current ramped up for 30 seconds, ramped back down for 30 seconds, and then remained off for the duration of the stimulation then and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation | Active comparator | ARM1: Transcranial direct current stimulation (tDCS) intervention and simultaneous balance training.
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week. Receives: Device: Transcranial direct current stimulation (tDCS) |
| ARM 2 | Sham comparator | ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control
Functional dynamic balance
Measured: After 5 days
Secondary outcomes (3)
Static Balance
linear analysis
Measured: After 5 days
Change of Static Balance
linear analysis
Measured: 1 week
Change of Static Balance
linear analysis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
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 Ischemic 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fariba Yadolahi, Shahid Beheshti University of Medical Sciences
- Investigators
- Fariba Yadolahi, MD-MPH-PhD, Principal investigator, Department of Physical therapy-School of Rehabilitation-Shahid Beheshti University of Medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209922
- Sponsor's protocol ID
- tDCS and postural control
- Other IDs
- 15840
- Status last verified
- Jul 2017
- First submitted
- 30 Jul 2014
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients ( A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT02209922
- Acronym / sponsor ID
- tDCS and postural control
- Conditions
- Ischemic Stroke
- Keywords
- tDCS, stroke, postural control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 6 Aug 2014 (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.
Purpose:
The incidence of stroke in low-to-middle income countries is increasing .Balance impairment and falling negatively impact function of stroke patients. Mobility is based on successful postural control and about 30% of individuals with stroke are unable to ambulate without assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor recovery in neurological disease.This can be addressed through a tDCS intervention.
Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on postural control in chronic stroke patients using laboratory and clinical assessments. The following essential treatment components; a) active tDCS stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance training program.
To identify combinations effects of tDCS stimulation plus balance training . Hypothesis: Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will significantly improve stroke clients' balance and functional mobility.
Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions
Experimental: Arm 1
tDCS brain stimulation and simultaneous balance training
Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days.
No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance training
Detailed description
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days, All outcome measures will be measured in 4 time points: pre-test, post-test after 10 sessions of intervention, and after 1 week and 1 months post intervention as follow ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation | Active comparator | Device: Transcranial direct current stimulation (tDCS)ARM1: Transcranial direct current stimulation (tDCS) intervention and simultaneous balance training. Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week. |
| ARM 2 | Sham comparator | Device: ShamARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age ≥18 years; first-ever ischemic stroke; chronic phase of recovery (>6 months); ability to walk 6- meter supported or unsupported; ability to stand at least unsupported for 40-seconds with eyes closed; only ischemic stroke involving middle cerebral artery (MCA) territory confirmed by CT or MRI.
Key exclusion criteria (1 listed)
- Use of any neuro- or psycho-active medications that alters balance; any other neurological conditions or sensory disorders affecting postural control; such as brain tumor, or substance abuse; orthopedic diseases; ongoing/recent (within 3 months) balance rehabilitation.
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 stimulation (tDCS)Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week. | Device | Transcranial direct current stimulation |
| ShamDuring sham stimulation, the current ramped up for 30 seconds, ramped back down for 30 seconds, and then remained off for the duration of the stimulation then and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week. | Device | ARM 2 |
Primary outcome
Postural control
Time frame: After 5 days
Functional dynamic balance
3 secondary outcomes
Static Balance
Time frame: After 5 days
Change of Static Balance
Time frame: 1 week
Change of Static Balance
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
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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.
Fariba Yadolahi, MD-MPH-PhD principal investigator
Department of Physical therapy-School of Rehabilitation-Shahid Beheshti University of Medical sciences
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 (tDCS) in people with Ischemic Stroke, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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 25 Jul 2017. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fariba Yadolahi, MD-PhD Candidate (00989109564012, fariba.yadolahi@sbmu.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural control (time frame: After 5 days). 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 NCT02209922, 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 25 Jul 2017.