Efficacy of REMO Training for Hand Motor Recovery After Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-04

Study Completion Date

2025-01-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Stroke, Ischemic Stroke Hemorrhagic Stroke Sequelae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized-Controlled Trial (RCT)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Clinical assessments will be performed before and after the treatment by a physical therapist not involved in training and blinded to the purpose and group allocation.

Study Groups

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REMO training

REMO training will consist of sEMG-biofeedback exercises provided by REMO device.

Group Type EXPERIMENTAL

REMO

Intervention Type DEVICE

REMO training will consist of sEMG-biofeedback exercises provided by REMO device. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks.

Task-Oriented training

Task-Oriented training will consist of task-specific functional exercises

Group Type ACTIVE_COMPARATOR

Task-Oriented Training

Intervention Type OTHER

Task-Oriented training will consist of task-specific functional exercises. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks.

Interventions

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REMO

REMO training will consist of sEMG-biofeedback exercises provided by REMO device. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks.

Intervention Type DEVICE

Task-Oriented Training

Task-Oriented training will consist of task-specific functional exercises. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes