Clinical trial NCT02209922: The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients
Official title: The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients ( A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: tDCS, stroke, postural control
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postural control
timeFrame: After 5 days
Secondary outcomes:
measure: Static Balance
timeFrame: After 5 days
measure: Change of Static Balance
timeFrame: 1 week
measure: Change of Static Balance
timeFrame: 1 month
Other outcomes:
measure: Postural sway flactuation
timeFrame: After 5 days
measure: Postural sway flactuation
timeFrame: 1 week
measure: Postural sway flactuation
timeFrame: 1 month
measure: Change of Postural control
timeFrame: 1 week
measure: Change of Postural control
timeFrame: 1 month
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti Univesity of Medical sciences
Study officials:
affiliation: Department of Physical therapy-School of Rehabilitation-Shahid Beheshti University of Medical sciences
name: Fariba Yadolahi, MD-MPH-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.