Efficacy of REMO Training for Hand Motor Recovery After Stroke

Stroke Clinical Trial

— REMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815368
• Other study ID #: 2021.13
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2022
• Est. completion date: January 13, 2025

Study information

• Verified date: February 2024
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: Giorgia Pregnolato
• Phone: +0412207
• Email: giorgia.pregnolato[@]hsancamillo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: January 13, 2025
• Est. primary completion date: January 13, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke Sequelae
• Stroke, Ischemic

Intervention

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.

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.

Locations

Country	Name	City	State
Italy	IRCCS San Camillo Hospital	Venice-Lido	Venice

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (5)

D. Rimini et al.,

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.

Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1. Erratum In: Circulation. 2022 May 3;145(18):e1033. Circulation. 2022 Sep 27;146(13):e185. Circulation. 2023 Apr 4;147(14):e674. — View Citation

Parker J, Powell L, Mawson S. Effectiveness of Upper Limb Wearable Technology for Improving Activity and Participation in Adult Stroke Survivors: Systematic Review. J Med Internet Res. 2020 Jan 8;22(1):e15981. doi: 10.2196/15981. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sEMG activation	The sEMG of forearm muscles will be collected using REMO device.	Change from Baseline sEMG muscle activation at 3 weeks
Primary	Fugl-Meyer Upper Extremity - hand	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.	Change from Baseline Fugl-Meyer Upper Extremity (hand items) at 3 weeks
Secondary	Fugl-Meyer Upper Extremity	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.	Change from Baseline Fugl-Meyer Upper Extremity at 3 weeks
Secondary	Fugl-Meyer Assessment - sensation	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.	Change from Baseline Fugl-Meyer Assessment (sensation) at 3 weeks
Secondary	Fugl-Meyer Assessment - pain and Range of Motion	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.	Change from Baseline Fugl-Meyer Assessment (pain and Range of Motion) at 3 weeks
Secondary	Box and Blocks Test	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.	Change from Baseline Box and Blocks Test at 3 weeks
Secondary	Reaching Performance Scale	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.	Change from Baseline Reaching Performance Scale at 3 weeks
Secondary	Modified Ashworth Scale - flexor carpi muscles	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).	Change from Baseline Modified Ashworth Scale (flexor carpi muscles) at 3 weeks
Secondary	Nine Hole Pegboard Test	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.	Change from Baseline Nine Hole Pegboard Test at 3 weeks
Secondary	Functional Independence Measure	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.	Change from Baseline Functional Independence Measure at 3 weeks
Secondary	Action Research Arm Test	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).	Change from Baseline Action Research Arm Test at 3 weeks
Secondary	Cylindric Grasp Force	The Cylindric Grasp Force is assessed with Dynamometer (CITEC Dynamometer, N).	Change from Baseline Cylindric Grasp Force at 3 weeks
Secondary	Abilhand questionnaire	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.'.	Change from Baseline Abilhand questionnaire at 3 weeks
Secondary	Abilhand questionnaire	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.'.	Change from Baseline Abilhand questionnaire at 7 weeks
Secondary	System Usability Scale	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.	Immediately after the intervention