Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke to Increase Upper Limb Motor Recovery, a Randomised, Controlled, Double-blind Study
Brief Summary: Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome.

We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans.

This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.


Options:
A: Arm Label: Fit For Function Program; Type: EXPERIMENTAL; Interventions: Other: Fit For Function Program | Arm Label: Standard YMCA membership; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard YMCA membership | Intervention Type: OTHER; Name: Fit For Function Program; Assigned to Arm(s): Fit For Function Program | Intervention Type: OTHER; Name: Standard YMCA membership; Assigned to Arm(s): Standard YMCA membership
B: Arm Label: Mobility-enhancing-nursing intervention; Type: EXPERIMENTAL; Interventions: Procedure: Mobility-enhancing-nursing intervention | Arm Label: Standard usual rehabilitation care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Mobility-enhancing-nursing intervention; Assigned to Arm(s): Mobility-enhancing-nursing intervention
C: Arm Label: 1 tDCS-Sham; Type: EXPERIMENTAL; Interventions: Procedure: transcranial direct current stimulation (tDCS) | Arm Label: 2 Sham-tDCS; Type: EXPERIMENTAL; Interventions: Procedure: Sham stimulation, then tDCS | Arm Label: 3 Sham-Sham; Type: SHAM_COMPARATOR; Interventions: Procedure: Sham stimulation | Intervention Type: PROCEDURE; Name: transcranial direct current stimulation (tDCS); Assigned to Arm(s): 1 tDCS-Sham | Intervention Type: PROCEDURE; Name: Sham stimulation, then tDCS; Assigned to Arm(s): 2 Sham-tDCS | Intervention Type: PROCEDURE; Name: Sham stimulation; Assigned to Arm(s): 3 Sham-Sham
D: Arm Label: tDCS + physical therapy; Type: EXPERIMENTAL; Interventions: Device: tDCS + physical therapy | Arm Label: Sham tDCS + physical therapy; Type: SHAM_COMPARATOR; Interventions: Device: tDCS + physical therapy | Intervention Type: DEVICE; Name: tDCS + physical therapy; Assigned to Arm(s): Sham tDCS + physical therapy, tDCS + physical therapy

Answer: C