Effects of Hand MOtor Rehabilitation Using a sEMG-biofeedback, After Stroke: a Longitudinal Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- IRCCS San Camillo, Venezia, Italy
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Upper Extremity
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Stroke is the first cause of disability worldwide. The motor impairment of the hand is one of the most common sequelae in patients after stroke. Indeed, approximately 60% of patients with diagnosis of stroke suffers from hand sensorimotor impairment. In the last years, new approaches in neurorehabilitation field has been permitted to enhance hand motor recovery. Wearable devices permit to apply sensors to the patient's body for monitoring the kinematic and dynamic characteristics of patient's motion. Moreover, wearable sensors combined with electrodes detecting muscle activation (i.e. surface electromyography - sEMG) permit to provide biofeedback to the patient to improve motor recovery.
Detailed Description
The aim of the study is to investigate the effect of using REMO® (Morecognition srl, Turin, Italy) device in hand motor rehabilitation. The device REMO® is an armband composed by 8 bipolar electrodes able to record and process the electromyography of forearm muscles. The patterns of muscle activations are classified and used to perform sEMG-biofeedback exercises in stroke rehabilitation training. The device is developed by clinicians of IRCCS San Camillo Hospital and Morecognition Srl. A total of 20 patients with first diagnosis of stroke and with no other neurological diagnosis or severe cognitive impairment has been enrolled. The patients are tested with REMO® and if they are able to control at least one movements, they are enrolled in the longitudinal pilot study. The treatment consists in 15 sessions, 1hour/day, for 5 days/week, for 3 weeks. The patients are clinically evaluated before and after the REMO® treatment to define clinical effect of the sEMG-biofeedback training.
Investigators
Andrea Turolla
Principal Investigator
IRCCS San Camillo, Venezia, Italy
Eligibility Criteria
Inclusion Criteria
- •Single ischemic or haemorrhagic stroke
- •able to control at least 1 movement with REMO (i.e. able to cross the pre-defined empirical threshold (10%) of the ratio between the maximum voluntary contraction (MVC) of the movement and the EMG recording during baseline (i.e. rest position)
Exclusion Criteria
- •Untreated epilepsy;
- •Major depressive disorder;
- •Fractures;
- •Traumatic Brain Injury;
- •Severe Ideomotor Apraxia;
- •Severe Neglect;
- •Severe impairment of verbal comprehension.
Outcomes
Primary Outcomes
Fugl-Meyer Upper Extremity
Time Frame: Change from baseline, at 3 weeks (15 sessions).
Fugl-Meyer Upper Extremity is a stroke-specific scale which assesses the upper limb motor functioning in patients with post-stroke hemiplegia. There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to upper limb hemiplegia. The maximum value is 66 points, which corresponds to normal motor performance.
Secondary Outcomes
- Fugl-Meyer - sensation(Change from baseline, at 3 weeks (15 sessions).)
- Fugl-Meyer - pain and Range of Motion(Change from baseline, at 3 weeks (15 sessions).)
- Box and Blocks Test(Change from baseline, at 3 weeks (15 sessions).)
- Reaching Performance Scale(Change from baseline, at 3 weeks (15 sessions).)
- Modified Ashworth Scale(Change from baseline, at 3 weeks (15 sessions).)
- Nine Hole Pegboard Test(Change from baseline, at 3 weeks (15 sessions).)
- Functional Independence Measure(Change from baseline, at 3 weeks (15 sessions).)
- Number of movements controlled by REMO® device(Change from baseline, at 3 weeks (15 sessions).)