A Phase 1/2 interventional study of Relief band (Somatosensory stimulation) and Placebo stimulation in Stroke, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-12-17.
Sponsored by University of Sao Paulo General Hospital · Phase 1/2, Interventional, and Treatment
Objective: To investigate effects of home-based somatosensory stimulation associated with motor training on improvement in performance of the paretic upper extremity in patients in the chronic phase after stroke.
Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based rehabilitation. Subjects: Patients in the chronic phase (> 6 months) after stroke. Interventions: Patients will be randomized to an active and a control group. In both groups, treatments will be performed at home, daily, over four weeks. Patients in the active group will be instructed to use a device that provides somatosensory stimulation in the form of electrical stimulation of the median nerve for two hours. Patients in the control group will also be instructed to use the device for two hours, and sham stimulation will be administered. In both groups, patients will be instructed to train activities with the paretic hand immediately after nerve stimulation.
Main measures: The primary outcome will be improvement in performance of the paretic hand evaluated by the Jebsen-Taylor test at end of treatment and four months after end of treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the interventions, assessed through a daily written log, and oral reports of the patients; 2) safety profile of the interventions.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Active group
Device: Relief band (Somatosensory stimulation)
Placebo stimulation
Device: Placebo stimulation
Electrical median nerve stimulation
Also known as: Relief band
Placebo stimulation
Also known as: no stimulation
the improvement in upper extremity performance assessed using Jebsen-Taylor test
Time frame: Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment
Compliance with the interventions, assessed through a daily written log, and oral reports of the patients
Time frame: immediately after the treatment
Adverse events
Time frame: at end of treatment
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital