Hemiparetic Arm Robotic Mobilization With Non Invasive Electrical Stimulation (NCT03026712) | Clinical Trial Compass
CompletedNot Applicable
Hemiparetic Arm Robotic Mobilization With Non Invasive Electrical Stimulation
Italy80 participantsStarted 2016-02
Plain-language summary
The two cerebral hemispheres find themselves in a state of balanced mutual inhibition. A stroke with involvement of motor function leads to a reduced excitability in affected hemisphere M1 and to an increased excitability of contralateral M1. Stroke therefore might impair interhemispheric balance, leading to a decreased inhibition of contralesional hemisphere by ipsilesional hemisphere and, in turn, to an increased inhibition of ipsilesional hemisphere by contralesional hemisphere. Permanence of healthy hemisphere hyperactivation in chronic phase after stroke is usually index of little functional recovery and is correlated with a greater ipsilateral structural damage.
Robot-mediated physical therapy is an innovative rehabilitation technique that is effective in stroke patients. In this study, the investigators will add a non-invasive brain stimulation protocol with Transcranial stimulation with direct current (tDCS) to the robotic treatment in chronic stroke patients. tDCS is a non-invasive brain stimulation technique that is able to modulate cortical excitability. The hypothesis is that dual t-DCS (ipsilesional excitation and concomitant contralesional inhibition) could restore interhemispheric balance improving the benefits of robotic therapy with Armeo Power®.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with isolated ischemic stroke, confirmed by brain imaging (MRI, CT)
* subjects who retain sufficient cognitive functions and language to follow the instructions given by doctors and therapists
* subjects with basal Modified Ashworth Scale score under 3
* subjects with basal Fugl-Meyer score ≥ 3 so that they are not completely paralyzed
* subjects who have signed informed consent to participate in this study
* subjects that show stable conditions in the two pre-treatment evaluations, in order to avoid "Hawthorne effect"
Exclusion Criteria:
* subjects with chronic paretic limb deformities
* subjects with complete and flaccid paralysis of all motor performances of shoulder and elbow;
* subjects with severe hemineglect (Pizzamiglio battery for unilateral spatial neglect including letter cancellation test, barrage tests, reading and Wundt-Jastro area illusion test; patients diagnosed with neglect if 3 of 4 items of this battery are present)
* subjects showing an increase in the Fugl-Meyer more than 2.1 points in the second pre-treatment clinical evaluation, compared to the score of the first evaluation
* subjects with contraindications to the execution of transcranial magnetic stimulation - TMS - (pacemakers, metal implants)
* subjects with epilepsy
* Previous neurosurgical interventions
* Severe upper limb osteoporosis
* Upper limb strength or joint movement limitation due to previous fractures
* Upper limb strength or joint movement limitation d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Significant Fugl-Meyer Assessment Upper Extremity (FMA-UE) improvement in real dual tDCS group vs sham tDCS group
Timeframe: first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training and at 1 and 3 months follow-up