The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients

Shahid Beheshti University of Medical Sciences

Status: Unknown

Conditions: Ischemic Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02610387

tDCS and Spasticity

Details and patient eligibility

About

Spasticity is one of the most common disorders in patients with central nervous system diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a noninvasive tool that can be used to modulate cortical excitability of the leg motor area, and the spinal motor circuits as well.

Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on lower limbs spasticity in chronic stroke patients using laboratory and clinical assessments.

Full description

In a randomized, sham-controlled, double-blinded clinical study, hemiplegic chronic stroke patients are randomized to receive active tDCS delivered to lesioned leg motor cortex (CZ) or sham combined with balance training with Biodex balance system.

Experimental group receive tDCS stimulation (2mA) for 20 min, 5 sessions in five days paired with 20 min balance training.

Enrollment: 40 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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40 participants in 2 patient groups

Arm 1:tDCS

Active Comparator group

Description:

Transcranial direct current stimulation (tDCS) Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days

Treatment:

Device: Transcranial direct current stimulation (tDCS)

Arm 2: Sham tDCS

Sham Comparator group

Description:

Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days

Treatment:

Device: Sham tDCS