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

The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients ( A Randomized Controlled Trial)

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Transcranial direct current stimulation (tDCS); Device: Sham tDCS

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fariba Yadolahi, MD-MPH-PhD Candidate; Phone Number: 989109564012; Email: fariba.yadolahi@sbmu.ac.ir

Study Locations

• Iran, Islamic Republic of
  • Velenjak
    • Tehran, Velenjak, Iran, Islamic Republic of, 1616931111
      • Recruiting
      • Shahid Beheshti Univesity of Medical sciences
      • Contact: Fariba Yadolahi, MD-MPH-PhD; Phone Number: +989109564012; Email: fariba.yadolahi@sbmu.ac.ir
      • Principal Investigator: Fariba Yadolahi, MD-MPH-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1:tDCS; Transcranial direct current stimulation (tDCS) Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days	Device: Transcranial direct current stimulation (tDCS); Participants underwent tDCS(2mA) brain stimulation for 20 minutes plus balance training for 20 minutes for 5 consecutive days.
Sham Comparator: Arm 2: Sham tDCS; Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days	Device: Sham tDCS; 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 plus balance training for 20 minutes for 5 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity (Modified Ashworth scale)	Modified Ashworth scale(MAS)	After 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motoneuron excitability (H-reflex latency)	H-reflex latency	After 5 days
Motoneuron excitability	H Max/M MaxRatio	After 5 days

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: September 12, 2016
• Primary Completion (Anticipated): December 20, 2017
• Study Completion (Anticipated): December 20, 2017

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 22, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: tDCS; stroke; Spasticity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Ischemic Stroke; Muscle Spasticity
• Other Study ID Numbers: tDCS and Spasticity