tDCS and Robotic Therapy in Stroke
|ClinicalTrials.gov Identifier: NCT01828398|
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : January 16, 2014
After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.
The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Upper Extremity Impairments||Device: real-tDCS + UE robot-assisted therapy Device: sham-tDCS + UE robot-assisted therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||November 2013|
Sham Comparator: sham-tDCS + UE robot-assisted therapy
This group will receive the same robot-assisted therapy of the intervention group, in association of sham-tDCS. This consists in a 30 seconds stimulation, with the same instrumentation and electrodes placement. This method of sham stimulation was previously validated.
Device: sham-tDCS + UE robot-assisted therapy
Experimental: real-tDCS + UE robot-assisted therapy
This group will receive continuous stimulation lasting 30 minutes during the session of robot-assisted therapy. The training session, which includes multiplanar, repetitive and target reaching movements, will be given 5 times a week for 2 weeks(REO Therapy System; Motorika, Medical LTD, Israel). Each session will last about 30 minutes.
Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the affected hemisphere and the cathode on the contralateral M1 area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries (Brainstim, EMS, Italy). This continuous stimulation lasted 30 minutes, with an intensity of 1mA.
Device: real-tDCS + UE robot-assisted therapy
- Fugl-Meyer Upper Extremity [ Time Frame: A week prior to treatment beginning ]Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
- Box and Block Test [ Time Frame: A week prior to treatment beginning ]Test for gross motor function. It counts the number of blocks that can be transported from one compartment of a box to another compartment within 1 minute.
- Ashworth Modified Scale [ Time Frame: A week prior to treatment beginning ]a 6 point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist
- Motor Activity Log (MAL) [ Time Frame: A week prior to treatment beginning ]Assessment of the change in real-world arm use in activities of daily living. Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities.
- Assessment of cortical excitability (TMS) [ Time Frame: A week prior to treatment beginning ]
MEP of upper limb muscles (first dorsal interosseous) will be recorded with surface EMG electrodes. neurophysiological parameters analyzed:
- motor threshold at rest
- MEP recruitment curve at rest
- MEP amplitude
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828398
|Ferrara University Hospital|