Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Villa Beretta Rehabilitation Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Motricity Index
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study evaulates the addition to the standard theraphy of enriched sensorimotor training by means of robotic glove therapy, or functional electrical stimulation in the treatment of chronic stroke patients with upper limb motor impairments. All the patients receive the conventional physiotherapic treatment. Supplemental to the conventional treatment, patients are evenly split in four groups to provide different treatments for an equivalent amount of time. Patient in the first group receive supplemental conventional therapy; patients in the second group receive robotic glove therapy; patients in the third group receive functional electrical stimulation; patients in the fourth group receive robotic glove treatment and functional electrical stimulation in different sessions.
Detailed Description
Stroke very frequently impacts on patients' motor function, and particularly on upper limb movements. Limited hand functionality is a major negative outcome after stroke, negatively affecting patients' recovery and independence, with major impact on rehabilitation.However, standard motor rehabilitation outcome is often suboptimal, because insufficient or non-specific treatment is provided. Robotic hand mobilization and functiona electrical stimulation grasp rehabilitation each improve motor capabilities in grasp impaired patients, but they do so by different mechanisms. Robotic hand mobilization achieves grasp rehabilitation by providing passive mobilization of the affected limb if the subject does not react to the designed task. Functional electrical stimulation achieves grasp rehabilitation by inducing localized muscle contraction, that is by providing an electrical field able to stimulate both sensory afferent pathways and lower motor neurons in the targeted volume.
Investigators
Dr. Franco Molteni
Clinical Director
Villa Beretta Rehabilitation Center
Eligibility Criteria
Inclusion Criteria
- •Adults male and/or female, older than 18 years
- •Patients who have suffered one or more strokes with major unilateral functional impairment
- •Hemiplegic, left and right unilateral lesion
- •Chronic phase of stroke at least six months before study enrollment
- •Level of impairment: hand and/or arm
- •No left handed
- •Mini-Mental State Examination \> 20
Exclusion Criteria
- •Limitation for using the device due to impairment of Passive Range of Motion and/or
- •Pain due to Spasticity evaluated using Modified Ashworth Scale (\>=3)
- •Previous history of major neurological or psychiatric disorders
- •allergy to electrodes
Outcomes
Primary Outcomes
Motricity Index
Time Frame: 9 weeks
Outcome measure to evaluate motor impairment after stroke; subscale for arm only; the subscale ranges from 0 (maximal impairment) to 100 (no impairment).
Secondary Outcomes
- Motor Activity Log(baseline; 9 weeks; 13 weeks.)
- Action Research Arm Test(baseline; 9 weeks; 13 weeks.)
- Medical Research Council(baseline, 9 weeks, 13 weeks.)
- Box & Blocks Test(baseline; 9 weeks; 13 weeks.)
- Modified Ashworth Scale(baseline; 9 weeks; 13 weeks)