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

July 22, 2017 updated by: Fariba Yadolahi, Shahid Beheshti University of Medical Sciences

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Velenjak
      • Tehran, Velenjak, Iran, Islamic Republic of, 1616931111
        • Recruiting
        • Shahid Beheshti Univesity of Medical sciences
        • Contact:
        • Principal Investigator:
          • Fariba Yadolahi, MD-MPH-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: After 5 days
Modified Ashworth scale(MAS)
After 5 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS and Spasticity

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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