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

Not Applicable

• Conditions: Ischemic Stroke
• Interventions: Device: Transcranial direct current stimulation (tDCS); Device: Sham

• Registration Number: NCT02209922
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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 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 Timeline

• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-06
• Study Start: 2014-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-22
• Last Update Posted: 2017-07-25
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial direct current stimulation	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	ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.

Primary Outcome Measures

Name	Time	Method
Postural control	After 5 days	Functional dynamic balance

Secondary Outcome Measures

Name	Time	Method
Change of Static Balance	1 month	linear analysis
Static Balance	After 5 days	linear analysis

Trial Locations

Locations (1)

Shahid Beheshti Univesity of Medical sciences; 🇮🇷 Tehran, Iran, Islamic Republic of