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

NCT ID: NCT02610387

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-12

Study Completion Date

2017-12-20

Brief Summary

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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

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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.

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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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

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

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

Arm 2: Sham tDCS

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

Group Type SHAM_COMPARATOR

Sham tDCS

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 plus balance training for 20 minutes for 5 consecutive days.

Interventions

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Transcranial direct current stimulation (tDCS)

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

Intervention Type DEVICE

Sham 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.

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

MD-MPH-PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shahid Beheshti Univesity of Medical sciences

Tehran, Velenjak, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Fariba Yadolahi, MD-MPH-PhD Candidate

Role: CONTACT

989109564012

Facility Contacts

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Fariba Yadolahi, MD-MPH-PhD

Role: primary

+989109564012

Other Identifiers

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tDCS and Spasticity

Identifier Type: -

Identifier Source: org_study_id

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