Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05995665 |
Other study ID # |
2020/01105 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 11, 2023 |
Est. completion date |
June 30, 2025 |
Study information
Verified date |
August 2023 |
Source |
Alexandra Hospital |
Contact |
Pui Kit Tam, MBBS |
Phone |
+65 -6779 5555 |
Email |
pui_kit_tam[@]nuhs.edu.sg |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 recovery.2. 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.
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 doctor's office 1 time (outpatient follow-up
post-discharge) in the course of the study.During 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 day.In 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 subject's standard care follow-up visit.The 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 intervention.It 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.