The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients
1 other identifier
interventional
40
1 country
1
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.
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 Sep 2016
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
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedStudy Start
First participant enrolled
September 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2017
CompletedJuly 25, 2017
July 1, 2017
1.3 years
November 18, 2015
July 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spasticity (Modified Ashworth scale)
Modified Ashworth scale(MAS)
After 5 days
Secondary Outcomes (2)
Motoneuron excitability (H-reflex latency)
After 5 days
Motoneuron excitability
After 5 days
Study Arms (2)
Arm 1:tDCS
ACTIVE COMPARATORTranscranial direct current stimulation (tDCS) Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days
Arm 2: Sham tDCS
SHAM COMPARATORSham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days
Interventions
Participants underwent tDCS(2mA) brain stimulation for 20 minutes plus balance training for 20 minutes for 5 consecutive days.
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.
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, Velenjak, 1616931111, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- MD-MPH-PhD candidate
Study Record Dates
First Submitted
November 18, 2015
First Posted
November 20, 2015
Study Start
September 12, 2016
Primary Completion
December 20, 2017
Study Completion
December 20, 2017
Last Updated
July 25, 2017
Record last verified: 2017-07