Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815368
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-03-16
Brief Title:
Efficacy of REMO Training for Hand Motor Recovery After Stroke
Sponsor:
IRCCS San Camillo Venezia Italy
Organization:
IRCCS San Camillo Venezia Italy
Study Overview
Official Title:
REcovery of Hand Motor Function in Stroke Rehabilitation Efficacy of a Task-Oriented Protocol Provided by a sEMG-biofeedback Wearable Device REMO
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMO
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 ie 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 TurinItaly 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 1hday 5dayweek 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
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 ie 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 TurinItaly 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 1hday 5dayweek 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 34 million adults will have had a stroke a 205 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 patients 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 ie 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 TurinItaly for hand motor recovery after stroke compared to a specific protocol of hand motor rehabilitation ie 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 1hourday for 5 daysweek 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
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 patients 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 ie 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 TurinItaly for hand motor recovery after stroke compared to a specific protocol of hand motor rehabilitation ie 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 1hourday for 5 daysweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None