Efficacy of REMO Training for Hand Motor Recovery After Stroke

Sponsor

IRCCS San Camillo, Venezia, Italy (Other)

Overall Status

Recruiting

CT.gov ID

NCT05815368

Collaborator

(none)

Enrollment

Location

Arms

15.3

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Stroke, Ischemic Stroke Hemorrhagic Stroke Sequelae	Device: REMO Other: Task-Oriented Training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized-Controlled Trial (RCT)Randomized-Controlled Trial (RCT)

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

REcovery of Hand Motor Function in Stroke Rehabilitation: Efficacy of a Task-Oriented Protocol Provided by a sEMG-biofeedback Wearable Device (REMO)

Actual Study Start Date :

Oct 4, 2022

Anticipated Primary Completion Date :

Jan 13, 2024

Anticipated Study Completion Date :

Jan 13, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: REMO training REMO training will consist of sEMG-biofeedback exercises provided by REMO device.	Device: 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.
Active Comparator: Task-Oriented training Task-Oriented training will consist of task-specific functional exercises	Other: 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.

Arm

Intervention/Treatment

Experimental: REMO training

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

Device: 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.

Active Comparator: Task-Oriented training

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

Other: 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.

Outcome Measures

Primary Outcome Measures

Fugl-Meyer Upper Extremity - hand [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 Outcome Measures

Fugl-Meyer Upper Extremity [Change from Baseline Fugl-Meyer Upper Extremity at 3 weeks]
Fugl-Meyer Upper Extremity is a stroke-specific scale which assesses the upper limb motor functions in patients with post-stroke hemiplegia. There are 3 values:0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0.
Fugl-Meyer Assessment - sensation [Change from Baseline Fugl-Meyer Assessment (sensation) at 3 weeks]
Sensation of the hemiparetic side is measured by means of the Fugl-Meyer Scale.There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to completely impaired sensory functioning. The maximum value is 24 points, which corresponds to normal sensory functioning.
Fugl-Meyer Assessment - pain and Range of Motion [Change from Baseline Fugl-Meyer Assessment (pain and Range of Motion) at 3 weeks]
Pain and Range of Motion of the hemiparetic upper limb is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to maximum level of pain and restriction. The maximum value is 48points, which corresponds to no pain and normal range of motion.
Box and Blocks Test [Change from Baseline Box and Blocks Test at 3 weeks]
The patient has to carry as much cubes as possible, one by one, from a box to another one in one minute. The test is performed with both hands.
Reaching Performance Scale [Change from Baseline Reaching Performance Scale at 3 weeks]
Reaching Performance Scale assesses the ability of subjects to reach an object (acone). The cone is placed at both 4-cm (close) and 30-cm (far) distance from the subject. The subject is asked to reach and grab the cone if possible. The assessor valuates the quality of reaching instead of the grip strength. The minimum value is0 points, which corresponds to incapacity of any ability of reaching an object. The maximum value is 36 points, which corresponds to the preservation of the ability to reach an object.
Modified Ashworth Scale - flexor carpi muscles [Change from Baseline Modified Ashworth Scale (flexor carpi muscles) at 3 weeks]
Level of spasticity of flexor carpi muscles is measured using the Modified Ashworth Scale. The therapist evaluates the spasticity of each muscles. There are 5 values: 0 (no increase in muscle tone), 1 (slight increase in muscle tone), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone), 4 (affected part rigid in flexion or extension).
Nine Hole Pegboard Test [Change from Baseline Nine Hole Pegboard Test at 3 weeks]
Nine Hole Pegboard Test measures the dexterity of the hand. Patient should insert9 pins in the board. There are 9 pins. The number of pins inserted in 50 sec are registered or if the patient inserted 9 pins, then the time is registered.
Functional Independence Measure [Change from Baseline Functional Independence Measure at 3 weeks]
Functional Independence Measure scale is an 18-item scale that assesses the level of independence in carrying out activities of daily living. There are 7 values:1 (Total Assistance or not Testable), 2 (Maximal Assistance), 3 (Moderate Assistance), 4 (Minimal Assistance), 5 (Supervision), 6 (Modified Independence), 7(Complete Independence). The minimum values is 18 points, which corresponds to the lower level of independence in activities of daily living. The maximum value is 126 points, which corresponds to the maximum level of independence in activities of daily living.
Action Research Arm Test [Change from Baseline Action Research Arm Test at 3 weeks]
Action Research Arm Test (ARAT) assesses upper limb functioning using observational methods. It is a 19 item measure divided into 4 sub-items (grasp, grip, pinch, gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally; 2) Completes test, but takes abnormally long or has great difficulty; 1) Performs test partially; 0) Can perform no part of test. The maximum score on the ARAT is 57 points (possible range 0 to57).
Cylindric Grasp Force [Change from Baseline Cylindric Grasp Force at 3 weeks]
The Cylindric Grasp Force is assessed with Dynamometer (CITEC Dynamometer, N).
Abilhand questionnaire [Change from Baseline Abilhand questionnaire at 3 weeks]
The ABILHAND questionnaire assesses bimanual ability as an interview-based test focused on the patient's perceived difficulty. Bimanual ability is defined as the capacity to manage daily activities that require the use of both hands, whatever the strategies involved. Three levels of response scale for each item, rated as 'Impossible=0, Difficult=1, Easy=2, Not applicable=missing data.'.
Abilhand questionnaire [Change from Baseline Abilhand questionnaire at 7 weeks]
The ABILHAND questionnaire assesses bimanual ability as an interview-based test focused on the patient's perceived difficulty. Bimanual ability is defined as the capacity to manage daily activities that require the use of both hands, whatever the strategies involved. Three levels of response scale for each item, rated as 'Impossible=0, Difficult=1, Easy=2, Not applicable=missing data.'.
System Usability Scale [Immediately after the intervention]
The System Usability Scale (SUS) provides a reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.