Clinical trial NCT05815368: Efficacy of REMO Training for Hand Motor Recovery After Stroke
Official title: REcovery of Hand Motor Function in Stroke Rehabilitation: Efficacy of a Task-Oriented Protocol Provided by a sEMG-biofeedback Wearable Device (REMO)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Stroke, Ischemic
Stroke Hemorrhagic
Stroke Sequelae
Keywords: Neurological Rehabilitation
Surface Electromyography
Upper Extremity
Motor Impairment
Biofeedback
Motor Recovery
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized-Controlled Trial (RCT)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fugl-Meyer Upper Extremity - hand
timeFrame: Change from Baseline Fugl-Meyer Upper Extremity (hand items) at 3 weeks
Secondary outcomes:
measure: Fugl-Meyer Upper Extremity
timeFrame: Change from Baseline Fugl-Meyer Upper Extremity at 3 weeks
measure: Fugl-Meyer Assessment - sensation
timeFrame: Change from Baseline Fugl-Meyer Assessment (sensation) at 3 weeks
measure: Fugl-Meyer Assessment - pain and Range of Motion
timeFrame: Change from Baseline Fugl-Meyer Assessment (pain and Range of Motion) at 3 weeks
measure: Box and Blocks Test
timeFrame: Change from Baseline Box and Blocks Test at 3 weeks
measure: Reaching Performance Scale
timeFrame: Change from Baseline Reaching Performance Scale at 3 weeks
measure: Modified Ashworth Scale - flexor carpi muscles
timeFrame: Change from Baseline Modified Ashworth Scale (flexor carpi muscles) at 3 weeks
measure: Nine Hole Pegboard Test
timeFrame: Change from Baseline Nine Hole Pegboard Test at 3 weeks
measure: Functional Independence Measure
timeFrame: Change from Baseline Functional Independence Measure at 3 weeks
measure: Action Research Arm Test
timeFrame: Change from Baseline Action Research Arm Test at 3 weeks
measure: Cylindric Grasp Force
timeFrame: Change from Baseline Cylindric Grasp Force at 3 weeks
measure: Abilhand questionnaire
timeFrame: Change from Baseline Abilhand questionnaire at 3 weeks
measure: Abilhand questionnaire
timeFrame: Change from Baseline Abilhand questionnaire at 7 weeks
measure: System Usability Scale
timeFrame: Immediately after the intervention
Other outcomes:
measure: sEMG activation
timeFrame: Change from Baseline sEMG muscle activation at 3 weeks
Locations:
city: Venice-Lido
country: Italy
facility: IRCCS San Camillo Hospital
state: Venice
Study officials:
affiliation: IRCCS San Camillo Hospital
name: Giorgia Pregnolato
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Di Girolamo M, Celadon N, Appendino S, Turolla A. and Ariano P. EMG-based biofeedback system for motor rehabilitation: A pilot study,. IEEE Biomedical Circuits and Systems Conference (BioCAS). 2017; pp. 1-4, doi: 10.1109/ BIOCAS.2017.8325086.
citation: D. Rimini et al.,
citation: Pregnolato G, Rimini D, Baldan F, Maistrello L, Salvalaggio S, Celadon N, Ariano P, Pirri CF, Turolla A. Clinical Features to Predict the Use of a sEMG Wearable Device (REMO(R)) for Hand Motor Training of Stroke Patients: A Cross-Sectional Cohort Study. Int J Environ Res Public Health. 2023 Mar 14;20(6):5082. doi: 10.3390/ijerph20065082.