The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients ( A Randomized Controlled Trial)

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Transcranial direct current stimulation (tDCS)
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcranial direct current stimulation<br>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. | Device: Transcranial direct current stimulation (tDCS)<br>* Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.<br>|
| Sham Comparator: ARM 2<br>ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week. | Device: Sham<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural control | Functional dynamic balance | After 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static Balance | linear analysis | After 5 days | 
| Change of Static Balance | linear analysis | 1 week | 
| Change of Static Balance | linear analysis | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, stroke, postural control