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.
- Relief band (Somatosensory stimulation) Device
Other Names: Relief band Intervention Desc: Electrical median nerve stimulation ARM 1: Kind: Experimental Label: Somatosensory stimulation Description: Active group
- Placebo stimulation Device
Intervention Desc: Placebo stimulation ARM 1: Kind: Experimental Label: Control group Description: Placebo stimulation
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||the improvement in upper extremity performance assessed using Jebsen-Taylor test||Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment||Yes|
|Secondary||Compliance with the interventions, assessed through a daily written log, and oral reports of the patients||immediately after the treatment||Yes|
|Secondary||Adverse events||at end of treatment||Yes|