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

Primary Purpose

Ischemic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Sham tDCS
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring tDCS, stroke, Spasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shahid Beheshti Univesity of Medical sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arm 1:tDCS

Arm 2: Sham tDCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Spasticity (Modified Ashworth scale)
Modified Ashworth scale(MAS)

Secondary Outcome Measures

Motoneuron excitability (H-reflex latency)
H-reflex latency
Motoneuron excitability
H Max/M MaxRatio

Full Information

First Posted
November 18, 2015
Last Updated
July 22, 2017
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02610387
Brief Title
The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients
Official Title
The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients ( A Randomized Controlled Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 12, 2016 (undefined)
Primary Completion Date
December 20, 2017 (Anticipated)
Study Completion Date
December 20, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
tDCS, stroke, Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1:tDCS
Arm Type
Active Comparator
Arm Description
Transcranial direct current stimulation (tDCS) Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days
Arm Title
Arm 2: Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
Participants underwent tDCS(2mA) brain stimulation for 20 minutes plus balance training for 20 minutes for 5 consecutive days.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spasticity (Modified Ashworth scale)
Description
Modified Ashworth scale(MAS)
Time Frame
After 5 days
Secondary Outcome Measure Information:
Title
Motoneuron excitability (H-reflex latency)
Description
H-reflex latency
Time Frame
After 5 days
Title
Motoneuron excitability
Description
H Max/M MaxRatio
Time Frame
After 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fariba Yadolahi, MD-MPH-PhD Candidate
Phone
989109564012
Email
fariba.yadolahi@sbmu.ac.ir
Facility Information:
Facility Name
Shahid Beheshti Univesity of Medical sciences
City
Tehran
State/Province
Velenjak
ZIP/Postal Code
1616931111
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fariba Yadolahi, MD-MPH-PhD
Phone
+989109564012
Email
fariba.yadolahi@sbmu.ac.ir
First Name & Middle Initial & Last Name & Degree
Fariba Yadolahi, MD-MPH-PhD

12. IPD Sharing Statement

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

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