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

Ischemic Stroke Clinical Trial

Official title:

The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients ( A Randomized Controlled Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02209922
• Other study ID #: tDCS and postural control
• Secondary ID: 15840
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2014
• Last updated: July 22, 2017
• Start date: December 2014
• Est. completion date: August 2017

Study information

• Verified date: July 2017
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Fariba Yadolahi, MD-PhD Candidate
• Phone: 00989109564012
• Email: fariba.yadolahi[@]sbmu.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Beheshti Univesity of Medical sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postural sway flactuation	nonlinear (Approximate entropy) analysis	After 5 days
Other	Postural sway flactuation	nonlinear (Approximate entropy) analysis	1 week
Other	Postural sway flactuation	nonlinear (Approximate entropy) analysis	1 month
Other	Change of Postural control	Functional dynamic balance	1 week
Other	Change of Postural control	Functional dynamic balance	1 month
Primary	Postural control	Functional dynamic balance	After 5 days
Secondary	Static Balance	linear analysis	After 5 days
Secondary	Change of Static Balance	linear analysis	1 week
Secondary	Change of Static Balance	linear analysis	1 month