MedPath

Transcranial Direct Current Stimulation in Stroke Rehabilitation

Not Applicable
Conditions
Stroke
Interventions
Device: Application of Transcranial direct current stimulation (TDCS)
Device: Transcranial Direct current stimulation
Registration Number
NCT01356654
Lead Sponsor
Universiteit Antwerpen
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
34
Inclusion Criteria
  1. Patients suffering from the consequences of a stroke in the medial cerebral artery, during the sub-acute phase (4-24 weeks after onset)
  2. Age between 18-75 years
  3. Hospitalised in rehabilitation Hospital Hof Ter Schelde
  4. Capable of understanding and giving informed consent
Exclusion Criteria
  1. Cerebellum or brainstem lesions
  2. Recently multiple lesions and older lesions which are manifested clinically.
  3. History of severe substance abuse (alcohol, drugs, benzodiazepines)
  4. Cardiac disease that in the opinion of the clinician precludes participation in the trial (severe dyspnea in rest, severe rhythm disturbances, etc)
  5. History of epileptic insults, not caused by the stroke
  6. Severe organic co morbidity
  7. Psychiatric disorders or history of psychiatric disorders
  8. Pace maker / internal defibrillator
  9. Pregnancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
SHAM TDCSApplication of Transcranial direct current stimulation (TDCS)-
True TDCSTranscranial Direct current stimulation-
Primary Outcome Measures
NameTimeMethod
Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months)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)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)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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Rehabilitation Hospital Hof Ter Schelde

🇧🇪

Antwerp, Belgium

© Copyright 2025. All Rights Reserved by MedPath