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

Ischemic Stroke Clinical Trial

Official title:

The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients ( A Randomized Controlled Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02610387
• Other study ID #: tDCS and Spasticity
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2015
• Last updated: July 22, 2017
• Start date: September 12, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: July 2017
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Fariba Yadolahi, MD-MPH-PhD Candidate
• Phone: 989109564012
• Email: fariba.yadolahi[@]sbmu.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 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
• Muscle Spasticity
• Stroke

Intervention

Device:
• Transcranial direct current stimulation (tDCS)
Participants underwent tDCS(2mA) brain stimulation for 20 minutes plus balance training for 20 minutes for 5 consecutive days.
• 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.

Locations

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

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
Primary	Spasticity (Modified Ashworth scale)	Modified Ashworth scale(MAS)	After 5 days
Secondary	Motoneuron excitability (H-reflex latency)	H-reflex latency	After 5 days
Secondary	Motoneuron excitability	H Max/M MaxRatio	After 5 days