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Clinical Trials/NCT01356654
NCT01356654
Unknown
Not Applicable

The Use of Transcranial Direct Current Stimulation in the Recovery of Postural Control in Stroke

Universiteit Antwerpen1 site in 1 country34 target enrollmentMarch 2010
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Universiteit Antwerpen
Enrollment
34
Locations
1
Primary Endpoint
Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months)
Last Updated
14 years ago

Overview

Brief Summary

This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation.

Detailed Description

The patients were divided in 2 groups by a randomisation procedure. All patients participated for 2 months in the study. Group 1 received true tDCS in the first month followed by SHAM stimulation in the second month. Group 2 received SHAM in the first month and true stimulation in the following month. Four stimulations of 20minutes were provided during 4 weeks before before changing stimulation intensity.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months)

Time Frame: baseline, after 1 month, After 2 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.

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)

Time Frame: baseline, after 1 month, After 2 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)

Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months)

Time Frame: baseline, after 1 month, After 2 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.

Study Sites (1)

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