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

Not Applicable

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

• Registration Number: NCT02610387
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Study Start: 2016-09-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-22
• Last Update Posted: 2017-07-25
• Primary Completion: 2017-12-20
• Study Completion: 2017-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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
Arm 2: Sham tDCS	Sham tDCS	Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days
Arm 1:tDCS	Transcranial direct current stimulation (tDCS)	Transcranial direct current stimulation (tDCS) Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days

Primary Outcome Measures

Name	Time	Method
Spasticity (Modified Ashworth scale)	After 5 days	Modified Ashworth scale(MAS)

Secondary Outcome Measures

Name	Time	Method
Motoneuron excitability (H-reflex latency)	After 5 days	H-reflex latency
Motoneuron excitability	After 5 days	H Max/M MaxRatio

Trial Locations

Locations (1)

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