Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients

Phase 1

Completed

• Conditions: Stroke
• Interventions: Device: Relief band (Somatosensory stimulation); Device: Placebo stimulation

• Registration Number: NCT01034150
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2009-09
• Status Verified: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-16
• Last Update Submitted: 2009-12-16
• Study First Posted: 2009-12-17
• Last Update Posted: 2009-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• age 18-80 years;
• single ischemic or hemorrhagic stroke in a cerebral hemisphere, documented by computed tomography (CT) or magnetic resonance imaging (MRI);
• stroke onset at least six months before;
• hand paresis with preserved ability to perform all tasks of the Jebsen-Taylor Test (JTT).

Exclusion Criteria

• previous strokes;
• epilepsy and other neurological conditions;
• proprioceptive or tactile anesthesia;
• shoulder or hand pain;
• severe joint deformity;
• severe chronic disease;
• inability to give provide informed consent due to severe aphasia or cognitive impairment;
• left handedness before the stroke.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Somatosensory stimulation	Relief band (Somatosensory stimulation)	Active group
Control group	Placebo stimulation	Placebo stimulation

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Compliance with the interventions, assessed through a daily written log, and oral reports of the patients	immediately after the treatment
Adverse events	at end of treatment

Trial Locations

Locations (1)

University of São Paulo/General Hospital; 🇧🇷 São Paulo, SP, Brazil