REcovery of Hand Motor Function in Stroke Rehabilitation: Efficacy of a Task-Oriented Protocol Provided by a sEMG-biofeedback Wearable Device (REMO)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- IRCCS San Camillo, Venezia, Italy
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Upper Extremity - hand
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Upper limb motor impairment is one of the most common sequelae after stroke. Indeed, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation.
In the last years, new approaches in neurorehabilitation field has been investigated to enhance motor recovery. The use of wearable devices combined with surface electromyography (i.e. sEMG) electrodes allows to detect patients muscle activation during motor performance. Moreover, sEMG is used to provide to the patients the biofeedback about their muscle activity during exercises execution to enhance motor control and motor recovery. The aim of the study is to define the efficacy of using REMO® (Morecognition srl, Turin,Italy) for hand motor recovery after stroke.
A randomised-controlled trial will be conducted compared to a task-oriented training, in hand motor rehabilitation after stroke. 28 patients with diagnosis of first stroke event will be enrolled in this study. After randomization process, participants will be allocated in Experimental Group (REMO training) or in Control Group (task-oriented training). The participants will be assessed before and after the treatment and sEMG will be collected during 12 hand movements. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). Finally, the sEMG of the same 12 hand movements will be collected from 15 healthy subjects to compare muscle activation with a normal reference model.
Detailed Description
Stroke is the first cause of permanent disability worldwide. The last American Heart Association (AHA) statistical update showed that in the next years the rate of people affected by stroke is going to increase, most in young people. Indeed, last projections showed that by 2030 an additional 3.4 million adults will have had a stroke, a 20.5% increase in prevalence from 2021. Moreover, upper limb motor impairment is one of the most common sequelae after stroke. The impairment of upper limb motor functions compromises the level of autonomy of the patients in activity of daily living. Thus, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation. In the last years, new approaches in neurorehabilitation field have been investigated to enhance motor recovery. The use of wearable devices consist of the application of sensors to the patient's body parts. The advantage of wearable sensor is to collect data from patients' movements to assess motor functions with high level of accuracy. Moreover, wearable device combined with surface electromyography (i.e. sEMG) electrodes allows to detect patients muscle activation during motor performance. sEMG is used also to provide to the patients the biofeedback about their muscle activity during exercises execution to enhance motor control and motor recovery. Surface electromyographic biofeedback showed good results in neurological conditions to improve motor control and hand motor recovery. The investigators developed a wearable device (REMO®) that collected sEMG from forearm muscles during hand movements. In recent works, the investigators defined the feasibility and security of using REMO in a rehabilitation setting. Moreover, the investigators defined the clinical features of stroke patients able to control the device to execute up to 10 hand movements in order to control a rehabilitation computer interface. The aim of this study is to define the efficacy of using REMO® (Morecognition srl, Turin,Italy) for hand motor recovery after stroke compared to a specific protocol of hand motor rehabilitation (i.e., task-oriented training). A randomised-controlled trial will be conducted compared to a task-oriented training, in hand motor rehabilitation after stroke. 28 patients with diagnosis of first stroke event, and with no other neurological diagnosis or severe cognitive impairment, will be enrolled in this study. After randomization process, participants will be allocated in Experimental Group (REMO training) or in Control Group (task-oriented training). The participants will be assessed before and after the treatment to define the clinical effects of the hand training. Moreover, the investigators will collect sEMG data using REMO device during 12 hand movements required to the patients before and after the training. The treatment consists of 15 sessions, (1hour/day, for 5 days/week, for 3 weeks). Finally, the sEMG of the same 12 hand movements will be collected from 15 healthy subjects to compare patients' muscle activation with a normal reference model.
Investigators
Giorgia Pregnolato
Laboratory of Healthcare Innovation Technology
IRCCS San Camillo, Venezia, Italy
Eligibility Criteria
Inclusion Criteria
- •Single ischemic or haemorrhagic stroke
- •Fugl-Meyer Upper Extremity score: minimum 10/66 points
Exclusion Criteria
- •Major depressive disorder;
- •Fractures;
- •Traumatic Brain Injury;
- •Severe Ideomotor Apraxia;
- •Severe Neglect;
- •Severe impairment of verbal comprehension.
Outcomes
Primary Outcomes
Fugl-Meyer Upper Extremity - hand
Time Frame: Change from Baseline Fugl-Meyer Upper Extremity (hand items) at 3 weeks
Fugl-Meyer Upper Extremity - hand section is a specific section of Fugl-Meyer Upper Extremity assessment that assesses the wrist and hand motor function in patients with post-stroke hemiplegia. There are 3 values:0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0. The maximum value is 24 points, which corresponds to normal hand motor function.
Secondary Outcomes
- Fugl-Meyer Assessment - pain and Range of Motion(Change from Baseline Fugl-Meyer Assessment (pain and Range of Motion) at 3 weeks)
- Fugl-Meyer Upper Extremity(Change from Baseline Fugl-Meyer Upper Extremity at 3 weeks)
- Modified Ashworth Scale - flexor carpi muscles(Change from Baseline Modified Ashworth Scale (flexor carpi muscles) at 3 weeks)
- Cylindric Grasp Force(Change from Baseline Cylindric Grasp Force at 3 weeks)
- Fugl-Meyer Assessment - sensation(Change from Baseline Fugl-Meyer Assessment (sensation) at 3 weeks)
- Box and Blocks Test(Change from Baseline Box and Blocks Test at 3 weeks)
- Reaching Performance Scale(Change from Baseline Reaching Performance Scale at 3 weeks)
- Abilhand questionnaire(Change from Baseline Abilhand questionnaire at 7 weeks)
- System Usability Scale(Immediately after the intervention)
- Nine Hole Pegboard Test(Change from Baseline Nine Hole Pegboard Test at 3 weeks)
- Functional Independence Measure(Change from Baseline Functional Independence Measure at 3 weeks)
- Action Research Arm Test(Change from Baseline Action Research Arm Test at 3 weeks)