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The Effects of tDCS Combined With Balance Training on Postural Control 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
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, postural control

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

Transcranial direct current stimulation

ARM 2

Arm Description

ARM1: Transcranial direct current stimulation (tDCS) intervention and simultaneous balance training. Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.

ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.

Outcomes

Primary Outcome Measures

Postural control
Functional dynamic balance

Secondary Outcome Measures

Static Balance
linear analysis
Change of Static Balance
linear analysis
Change of Static Balance
linear analysis

Full Information

First Posted
July 30, 2014
Last Updated
July 22, 2017
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02209922
Brief Title
The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients
Official Title
The Effects of tDCS Combined With Balance Training on Postural Control 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
December 2014 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 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
Purpose: The incidence of stroke in low-to-middle income countries is increasing .Balance impairment and falling negatively impact function of stroke patients. Mobility is based on successful postural control and about 30% of individuals with stroke are unable to ambulate without assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor recovery in neurological disease.This can be addressed through a tDCS intervention. Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on postural control in chronic stroke patients using laboratory and clinical assessments. The following essential treatment components; a) active tDCS stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance training program. To identify combinations effects of tDCS stimulation plus balance training . Hypothesis: Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will significantly improve stroke clients' balance and functional mobility. Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions Experimental: Arm 1 tDCS brain stimulation and simultaneous balance training Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days. No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance training
Detailed Description
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days, All outcome measures will be measured in 4 time points: pre-test, post-test after 10 sessions of intervention, and after 1 week and 1 months post intervention as follow ups.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Transcranial direct current stimulation
Arm Type
Active Comparator
Arm Description
ARM1: Transcranial direct current stimulation (tDCS) intervention and simultaneous balance training. Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
Arm Title
ARM 2
Arm Type
Sham Comparator
Arm Description
ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
Intervention Type
Device
Intervention Name(s)
Sham
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 then and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
Primary Outcome Measure Information:
Title
Postural control
Description
Functional dynamic balance
Time Frame
After 5 days
Secondary Outcome Measure Information:
Title
Static Balance
Description
linear analysis
Time Frame
After 5 days
Title
Change of Static Balance
Description
linear analysis
Time Frame
1 week
Title
Change of Static Balance
Description
linear analysis
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Postural sway flactuation
Description
nonlinear (Approximate entropy) analysis
Time Frame
After 5 days
Title
Postural sway flactuation
Description
nonlinear (Approximate entropy) analysis
Time Frame
1 week
Title
Postural sway flactuation
Description
nonlinear (Approximate entropy) analysis
Time Frame
1 month
Title
Change of Postural control
Description
Functional dynamic balance
Time Frame
1 week
Title
Change of Postural control
Description
Functional dynamic balance
Time Frame
1 month

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-PhD Candidate
Phone
00989109564012
Email
fariba.yadolahi@sbmu.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fariba Yadolahi, MD-MPH-PhD
Organizational Affiliation
Department of Physical therapy-School of Rehabilitation-Shahid Beheshti University of Medical sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Beheshti Univesity of Medical sciences
City
Tehran
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

Citations:
PubMed Identifier
33175411
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived

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The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients

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