The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients
2 other identifiers
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJuly 25, 2017
July 1, 2017
2.7 years
July 30, 2014
July 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postural control
Functional dynamic balance
After 5 days
Secondary Outcomes (3)
Static Balance
After 5 days
Change of Static Balance
1 week
Change of Static Balance
1 month
Other Outcomes (5)
Postural sway flactuation
After 5 days
Postural sway flactuation
1 week
Postural sway flactuation
1 month
- +2 more other outcomes
Study Arms (2)
Transcranial direct current stimulation
ACTIVE COMPARATORARM1: Transcranial direct current stimulation (tDCS) intervention and simultaneous balance training. Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
ARM 2
SHAM COMPARATORARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
Interventions
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
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 then and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shahid Beheshti Univesity of Medical sciences
Tehran, 1616931111, Iran
Related Publications (1)
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.
PMID: 33175411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fariba Yadolahi, MD-MPH-PhD
Department of Physical therapy-School of Rehabilitation-Shahid Beheshti University of Medical sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fariba Yadolahi-MD-MPH-PhD Candidate in physical therapy
Study Record Dates
First Submitted
July 30, 2014
First Posted
August 6, 2014
Study Start
December 1, 2014
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
July 25, 2017
Record last verified: 2017-07