Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05995665
Status:
RECRUITING
Last Update Posted:
2023-08-16
First Post:
2023-08-09
Brief Title:
Assistive Soft Robotic Glove EsoGLOVE Intervention for Stroke Patients
Sponsor:
Alexandra Hospital
Organization:
Alexandra Hospital
Study Overview
Official Title:
Assistive Soft Robotic Glove EsoGLOVE Intervention for Stroke Patients
Status:
RECRUITING
Status Verified Date:
2023-08
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:
None
Brief Summary:
This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE with Trigno Biofeedback EMG sensors in the inpatient rehabilitation setting 1 Understanding the ability of the EsoGLOVE with Trigno Biofeedback EMG sensors in providing CPM exercise and assisting stroke patients with completing hand functional tasks eventually improves patients motor function and neural recovery2 To generate evidence on this innovative device and further deploy it in clinical practice A Health Technology Assessment HTA will be generated from this study to evaluate the cost-effectiveness of the intervention
Detailed Description:
This project proposes a study of 130 subjects in inpatient settings who have sustained their first-ever stroke prior to clinical trial enrolment Participants are randomly assigned to 2 groups EsoGLOVE with Trigno Biofeedback EMG sensors group and GRASP group The randomization method A block randomization with a randomly varying block size The study will last 12 weeks 3 weeks of intervention during hospitalization 12th-week outpatient follow-up post-discharge The subjects will use the study device about 15 times and be followed up for 3 weeks during hospitalization
The subjects will need to visit the doctors office 1 time outpatient follow-up post-discharge in the course of the studyDuring the hospitalization the stroke patients subjects will receive intensive stroke rehabilitation as per normal which will be daily physiotherapy and occupational therapy as a part of standard care as per stroke rehabilitation On top of the standard care daily Inpatient OT Rehabilitation the EsoGLOVE Trigno subjects will receive EsoGLOVE with Trigno Biofeedback EMG sensors training on therapy day for 3 weeks week 1 to week 3 sessions will be done every Monday to Friday a minimum of 30 minutes per day While the GRASP group subjects will receive the Graded Repetitive Arm Supplementary Program GRASP on therapy day Monday to Friday for 3 weeks a minimum of 30 minutes per dayIn the case of early discharge or withdrawal for any reason before the 3-week intervention is completed the subjects will no longer participate in this study and no study-related activities will be performed on the subjects The subjects right to receive standard care will remain the same as per hospital guidelines and will not be affected This is applicable to both groups With minimal compliance rate 12 sessions for continuing the study regardless of the subjects discharge before 3 weeks otherwise less than or equal to 11 sessions subjects will be withdrawn at the day of discharge or withdrawal The 12th-week outpatient follow-up post-discharge at the clinic will coincide with the subjects standard care follow-up visitThe Health Technology Assessment HTA is conducted by the study team using explicit analytical frameworks clinical outcomes epidemiological data amp statistics health economic information and study methodology The assessment includes building evidence on the qualities and costs of health interventions cost-effectiveness identifying the direct amp indirect medical costs in the current healthcare system capturing the clinical outcomes of interventions synthesizing health research findings of the effectiveness of different health interventions evaluating the economic implications and analyzing the cost-effectiveness of the interventionIt is unlikely this study might unintentionally come to know of new information Incidental Finding about the health condition from the assessment Fugl-Meyer Assessment - Upper Extremity of the study
The subjects will need to visit the doctors office 1 time outpatient follow-up post-discharge in the course of the studyDuring the hospitalization the stroke patients subjects will receive intensive stroke rehabilitation as per normal which will be daily physiotherapy and occupational therapy as a part of standard care as per stroke rehabilitation On top of the standard care daily Inpatient OT Rehabilitation the EsoGLOVE Trigno subjects will receive EsoGLOVE with Trigno Biofeedback EMG sensors training on therapy day for 3 weeks week 1 to week 3 sessions will be done every Monday to Friday a minimum of 30 minutes per day While the GRASP group subjects will receive the Graded Repetitive Arm Supplementary Program GRASP on therapy day Monday to Friday for 3 weeks a minimum of 30 minutes per dayIn the case of early discharge or withdrawal for any reason before the 3-week intervention is completed the subjects will no longer participate in this study and no study-related activities will be performed on the subjects The subjects right to receive standard care will remain the same as per hospital guidelines and will not be affected This is applicable to both groups With minimal compliance rate 12 sessions for continuing the study regardless of the subjects discharge before 3 weeks otherwise less than or equal to 11 sessions subjects will be withdrawn at the day of discharge or withdrawal The 12th-week outpatient follow-up post-discharge at the clinic will coincide with the subjects standard care follow-up visitThe Health Technology Assessment HTA is conducted by the study team using explicit analytical frameworks clinical outcomes epidemiological data amp statistics health economic information and study methodology The assessment includes building evidence on the qualities and costs of health interventions cost-effectiveness identifying the direct amp indirect medical costs in the current healthcare system capturing the clinical outcomes of interventions synthesizing health research findings of the effectiveness of different health interventions evaluating the economic implications and analyzing the cost-effectiveness of the interventionIt is unlikely this study might unintentionally come to know of new information Incidental Finding about the health condition from the assessment Fugl-Meyer Assessment - Upper Extremity of the study
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?:
False
Is an FDA AA801 Violation?:
None