Transcranial Direct Current Stimulation in Stroke Rehabilitation
The Use of Transcranial Direct Current Stimulation in the Recovery of Postural Control in Stroke
1 other identifier
interventional
34
1 country
1
Brief Summary
This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Mar 2010
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
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMay 19, 2011
May 1, 2011
1.3 years
May 10, 2011
May 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months)
The static sitting balance subscale assesses whether a subject can sit independently and remain seated when the legs are either passively or actively crossed. The dynamic sitting balance subscale evaluates the ability to actively shorten each side of the trunk, first initiated from the shoulder and subsequently initiated from the pelvic girdle. Trunk coordination is evaluated by the possibility to independently rotate the upper and lower part of the trunk. The scoring range for the static and dynamic sitting balance and coordination subscales are 7, 10 and 6 points respectively.
baseline, after 1 month, After 2 months
Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months)
The RMAB assesses the motor performance of patients with stroke.32 It consists of test items clustered in three sections that are ordered hierarchically. The gross function subscale (13 items), the Leg and Trunk subscale (10 items) and the arm subscale (15 items)
baseline, after 1 month, After 2 months
Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months)
The Tinetti Test is an easily performed test that measures a patients' gait and balance. The individual scores are combined to form three measures; a gait score, a standing balance score and a total score. The maximum score for the gait component and the balance component are 12 and 16 points respectively, resulting in a maximum of 28 points for the total score.
baseline, after 1 month, After 2 months
Study Arms (2)
SHAM TDCS
SHAM COMPARATORTrue TDCS
ACTIVE COMPARATORInterventions
Application of TDCS for 20 minutes, 4 times a week for 4 weeks.
Application of true TDCS for 20min, 4 times a week for 4 weeks.
Eligibility Criteria
You may qualify if:
- Patients suffering from the consequences of a stroke in the medial cerebral artery, during the sub-acute phase (4-24 weeks after onset)
- Age between 18-75 years
- Hospitalised in rehabilitation Hospital Hof Ter Schelde
- Capable of understanding and giving informed consent
You may not qualify if:
- Cerebellum or brainstem lesions
- Recently multiple lesions and older lesions which are manifested clinically.
- History of severe substance abuse (alcohol, drugs, benzodiazepines)
- Cardiac disease that in the opinion of the clinician precludes participation in the trial (severe dyspnea in rest, severe rhythm disturbances, etc)
- History of epileptic insults, not caused by the stroke
- Severe organic co morbidity
- Psychiatric disorders or history of psychiatric disorders
- Pace maker / internal defibrillator
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universiteit Antwerpenlead
- Rehabilitation Hospital Hof Ter Scheldecollaborator
- Artesis University College, Antwerpcollaborator
Study Sites (1)
Rehabilitation Hospital Hof Ter Schelde
Antwerp, Antwerp, 2050, Belgium
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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 19, 2011
Study Start
March 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
May 19, 2011
Record last verified: 2011-05