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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02610387

Enrollment

Registered

2015-11-20

Start date

2016-09-12

Completion date

2017-12-20

Last updated

2017-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

tDCS, stroke, Spasticity

Brief 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.

Detailed 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.

Interventions

DEVICETranscranial direct current stimulation (tDCS)

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

DEVICESham 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Spasticity (Modified Ashworth scale)	After 5 days	Modified Ashworth scale(MAS)

Secondary

Measure	Time frame	Description
Motoneuron excitability (H-reflex latency)	After 5 days	H-reflex latency
Motoneuron excitability	After 5 days	H Max/M MaxRatio

Countries

Iran

Contacts

Primary ContactFariba Yadolahi, MD-MPH-PhD Candidate

fariba.yadolahi@sbmu.ac.ir989109564012

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026