Overview

This trial is active, not recruiting.

Condition ischemic stroke
Treatments transcranial direct current stimulation (tdcs), sham tdcs
Sponsor Shahid Beheshti University of Medical Sciences
Start date November 2015
End date December 2016
Trial size 40 participants
Trial identifier NCT02610387, tDCS and Spasticity

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Transcranial direct current stimulation (tDCS) Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days
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 Comparator)
Sham tDCS and simultaneous balance training(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.

Primary Outcomes

Measure
Spasticity (Modified Ashworth scale)
time frame: After 5 days

Secondary Outcomes

Measure
Motoneuron excitability (H-reflex latency)
time frame: After 5 days
Motoneuron excitability
time frame: After 5 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients ( A Randomized Controlled Trial)
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Shahid Beheshti University of Medical Sciences.