Stroke, Acute
Conditions
Keywords
tDCS, WMFT, Semmes Weinstein, Acute stroke
Brief summary
Acute stroke patient will undergo one month (20 sessions) of physical therapy and anodal tDCS. Patients will undergo functional outcomes measured at 48h post onset, 7,14,21,28 days, 3 and 6 months and one year post onset.
Detailed description
Recruitment : Patients with acute stroke (24-48h after stroke) who have upper and / or lower sensorimotor deficits • Treatment : After being selected according to the inclusion and exclusion criteria of this study, patients will be randomized and placed in one of two groups: placebo (P) or transcranial anodic stimulation (A). Once placed in one of two groups, patients will all receive intensive physiotherapy for functional improvement in order to increase motor, postural and motor control. This physiotherapy will be established 5 times a week (Monday to Friday). In addition to physiotherapy, the patient will have electrodes placed on his head, attached via a system of straps, to deliver either a continuous current (A) or no current (P) and at a rate of 5 times per week for 4 weeks. Neither the physiotherapist nor the patient will know what treatment he will have received. • Evaluations and measurements: Patients will be required to perform functional tests of the upper limb (Wolf Motor Function Test (WMFT)), filmed and timed, a test of spasticity (Tardieu) as well as to answer certain questionnaires concerning their perception of the evolution of the disease and their disability (Stroke Impact Scale, Barthel Index), their emotional state (HADS), if they have experienced side effects, sensitivity test with monofilaments or Semmes and Weinstein test, the Fugl Meyer, the timed up and go, the test of 10m, the four step square test, the berg balance scale, the postural assessment scale and the trunk impairment scale. These evaluations will take place at Day 0 (corresponding to the first day after the 48h of strict bedtime), Day 7, 15, 30, 90, 6 months and 1 year. They will be done in two stages, on two successive days, so as not to exhaust the patient.
Interventions
DEVICEtDCS
20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The device is preprogrammed by a third party non participating in any element in the study. They then chose (using opaque envelopes) the treatment code for each participant.
Intervention model description
randomized, triple blind, sham controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Woman or man * Between 18 and 80 years old * First ever stroke * Capable of signing the consent form
Exclusion criteria
* One on the TSST (in high and relatively high risk sections) * Previous neurological or orthopedic pathologies affecting limbs * Cognitive deficits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test Change | 48 hours post onset, 7, 14, 21 and 28 days post onset, 3 and 6 months post onset and 1 year post onset | Functional outcome of the paretic limb |
| Semmes Weinstein Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | Monofilament sensory test |
| Timed up and go Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | walking test |
| 10 meter walk test Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | Walking speed test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 4 square step test Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | Balance test, the higher the score the higher the worse the patient is |
| Berg Balance scale Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | Balance test, the higher the score the higher the score, the better the patient is |
| Tardieu spasticity scale Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | spasticity scale, the higher the score the higher the spasticity |
| Trunk impairment scale Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | balance test, the higher the score the higher the better the patient is |
| Postural assessement scale Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | Balance test, the higher the score the higher the better the patient is |
| Stroke impact scale Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | Scale measuring impact of stroke on life, the higher the score the higher the worse off the patient is |
| HADS Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | Depression and anxiety scale, the higher the score the higher the more depressed or anxious the patient is |
| Fugl Meyer Change | 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset | Upper and lower limb motor outcomes, the higher the score the higher the better the patient is |
Countries
Belgium
Contacts
Primary ContactStephen Bornheim, Msc
Backup ContactJean-François Kaux, Phd, MD
Outcome results
None listed