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| ID | Type | Description | Link |
|---|---|---|---|
| 15840 | Other Identifier | Shahid Beheshti University of Medical Sciences-IRAN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| ARM 2 | Sham Comparator | ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postural control | Functional dynamic balance | After 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Static Balance | linear analysis | After 5 days |
| Change of Static Balance | linear analysis | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Postural sway flactuation | nonlinear (Approximate entropy) analysis | After 5 days |
| Postural sway flactuation | nonlinear (Approximate entropy) analysis |
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fariba Yadolahi, MD-PhD Candidate | Contact | 00989109564012 | fariba.yadolahi@sbmu.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Fariba Yadolahi, MD-MPH-PhD | Department of Physical therapy-School of Rehabilitation-Shahid Beheshti University of Medical sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Beheshti Univesity of Medical sciences | Recruiting | Tehran | 1616931111 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33175411 | Derived | 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. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham | Device | 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. |
|
| Change of Static Balance | linear analysis | 1 month |
| 1 week |
| Postural sway flactuation | nonlinear (Approximate entropy) analysis | 1 month |
| Change of Postural control | Functional dynamic balance | 1 week |
| Change of Postural control | Functional dynamic balance | 1 month |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |