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

NCT ID: NCT02209922

Last Updated: 2017-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Transcranial direct current stimulation

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.

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.

ARM 2

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

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Fariba Yadolahi

Fariba Yadolahi-MD-MPH-PhD Candidate in physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fariba Yadolahi, MD-MPH-PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical therapy-School of Rehabilitation-Shahid Beheshti University of Medical sciences

Locations

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Shahid Beheshti Univesity of Medical sciences

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Fariba Yadolahi, MD-PhD Candidate

Role: CONTACT

00989109564012

Facility Contacts

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Fariba Yadolahi, MD-MPH-PhD

Role: primary

+989109564012

References

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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.

Reference Type DERIVED
PMID: 33175411 (View on PubMed)

Other Identifiers

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15840

Identifier Type: OTHER

Identifier Source: secondary_id

tDCS and postural control

Identifier Type: -

Identifier Source: org_study_id

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