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Status unknownNCT02610387Updated Jul 25, 2017

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

An interventional study of Transcranial direct current stimulation (tDCS) and Sham tDCS in Ischemic Stroke, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-25.

Sponsored by Shahid Beheshti University of Medical Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • tDCS
  • stroke
  • Spasticity
03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's planned enrollment of 40 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • 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)

  • Sham comparator
    Arm 2: Sham tDCS

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

    Device: Sham tDCS

Interventions

  • DeviceTranscranial direct current stimulation (tDCS)

    Participants underwent tDCS(2mA) brain stimulation for 20 minutes plus balance training for 20 minutes for 5 consecutive days.

  • DeviceSham 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.

06

What researchers measure

Primary outcomes

  1. Spasticity (Modified Ashworth scale)

    Modified Ashworth scale(MAS)

    Time frame: After 5 days

Secondary outcomes

  1. Motoneuron excitability (H-reflex latency)

    H-reflex latency

    Time frame: After 5 days

  2. Motoneuron excitability

    H Max/M MaxRatio

    Time frame: After 5 days

07

Study locations

1 of 1 sites recruiting
  • Shahid Beheshti Univesity of Medical sciences
    Tehran, Velenjak 1616931111, Iran
    • Fariba Yadolahi, MD-MPH-PhD · Contact · fariba.yadolahi@sbmu.ac.ir · +989109564012
    • Fariba Yadolahi, MD-MPH-PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02610387
Responsible party
Fariba Yadolahi (MD-MPH-PhD candidate, Shahid Beheshti University of Medical Sciences) — Principal investigator
First posted
Nov 20, 2015
Start date
Sep 12, 2016
Primary completion
Dec 20, 2017 (estimated)
Completion
Dec 20, 2017 (estimated)
Last update
Jul 25, 2017

Study contacts

Fariba Yadolahi, MD-MPH-PhD Candidate
Contact
fariba.yadolahi@sbmu.ac.ir
989109564012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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