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

Shahid Beheshti University of Medical Sciences

Status: Unknown

Conditions: Ischemic Stroke

Treatments: Device: Sham; Device: Transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02209922

15840 (Other Identifier)

tDCS and postural control

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Transcranial direct current stimulation

Active Comparator group

Description:

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.

Treatment:

Device: Transcranial direct current stimulation (tDCS)

ARM 2

Sham Comparator group

Description:

ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.

Treatment:

Device: Sham