StrokeNCT05995665
Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients
A study testing EsoGLOVE and Graded Repetitive Arm Supplementary Program (GRASP) in people with Stroke, run by Alexandra Hospital at 2 sites in Singapore.
Trial summary
This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE in the inpatient rehabilitation setting. 1. Understanding the ability of the EsoGLOVE in providing exercise and assisting stroke patients with completing hand functional tasks, eventually improves patients' motor function and neural… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- EsoGLOVE and Graded Repetitive Arm Supplementary Program (GRASP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesSingapore
- Study dates
- 11 Jul 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21-90 years regardless of lesion size, race
- Stroke type: ischemic or haemorrhagic
- Medically stable conditions
- Fugl-Meyer Assessment (FMA) of upper extremity impairment from 8-47 out of 66, or FMA of upper extremity impairment from 48-56 out of 66 if hand and wrist subscale is not full score and may still potentially benefit from study programme.
- Able to give own consent, comprehend and follow commands
- Able to sit upright and maintain sitting balance for at least 45 minutes
- Able to stay alert and focus on the tasks at least 45 minutes and more.
- Unilateral upper limb impairment
Who cannot join
- Recurrent stroke
- Unstable medical conditions (e.g. heart attack, unstable blood pressure, infection, and etc.) or anticipated life expectancy of <1 year.
- Significant cognitive and communicative impairment (e.g. severe receptive aphasia, inattention, learning difficulty, and etc).
- History of severe depression or active psychiatric disorder.
- Severe spasticity (Modified Ashworth scale >3) of the affected distal muscles, joint contractures or deformity, poor skin conditions (e.g. irritated skin, open wounds), amputation of fingers, and allergic condition (e.g. patients with allergies to adhesive gel).
- Poor trunk control or postural hypotension.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Alexandra Hospital
Singapore
Jurong Community Hospital
Singapore
About this study
This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE in the inpatient rehabilitation setting. 1. Understanding the ability of the EsoGLOVE in providing 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.
Read the 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 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 subjects will receive EsoGLOVE 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 (10 sessions) for continuing the study, regardless of the subjects' discharge before 3 weeks, otherwise (less than or equal to 9 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.
- Conditions
- Stroke
- Being tested
- EsoGLOVE, Graded Repetitive Arm Supplementary Program (GRASP)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsoGLOVEDevice
The dose is referred to the stay of inpatient setting. The stroke patients will be transferred to community hospital when medically stable. The average of stay in community hospital is 3 weeks. The stroke patients will receive intensive stroke rehabilitation during the stay, which will be daily physiotherapy and occupational therapy. The subjects will receive EsoGLOVE training on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day, up to 15 sessions. This is similar to the dose in a similar trial (DSRB 2017/00312, Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture).
Graded Repetitive Arm Supplementary Program (GRASP)Other
Graded Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| EsoGLOVE | Experimental | The EsoGLOVEGroup subjects will receive EsoGLOVE 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 Receives: Device: EsoGLOVE |
| Graded Repetitive Arm Supplementary Program (GRASP) Group | Active comparator | 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 Receives: Other: Graded Repetitive Arm Supplementary Program (GRASP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for the Upper Extremity
upper limb impairment scale ranged from 0-66 with higher score indicating better outcome
Measured: Baseline, immediately post-intervention and 3 months post-intervention
Secondary outcomes (3)
Stroke Impact Scale-16
consists of 16 items from the 4 physical domains (strength, hand function, mobility, and ADL/IADL) ranged from 16 to 80 with higher score indicating better outcome
Measured: Baseline, immediately post-intervention and 3 months post-intervention
Stroke Upper Limb Capacity Scale
Activities limitation of upper limb ranged 0 to10 with higher score indicating better outcome
Measured: Baseline, immediately post-intervention and 3 months post-intervention
Duruoz Hand Index
self-reported upper limb function ranged 0 to 90 with higher score indicating worse outcome
Measured: Baseline, immediately post-intervention and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start11 Jul 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandra Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jurong Community Hospital, Singapore, Roceso Technologies
- Responsible party
- Sponsor
- Investigators
- Pui Kit Tam, MBBS, Principal investigator, Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995665
- Sponsor's protocol ID
- 2020/01105
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients
- ClinicalTrials.gov ID
- NCT05995665
- Acronym / sponsor ID
- 2020/01105
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Alexandra HospitalUniversity, hospital or other
- Collaborators
- Jurong Community Hospital, Singapore, Roceso Technologies
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE in the inpatient rehabilitation setting. 1. Understanding the ability of the EsoGLOVE in providing 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.
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 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 subjects will receive EsoGLOVE 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 (10 sessions) for continuing the study, regardless of the subjects' discharge before 3 weeks, otherwise (less than or equal to 9 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EsoGLOVE | Experimental | Device: EsoGLOVEThe EsoGLOVEGroup subjects will receive EsoGLOVE 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 |
| Graded Repetitive Arm Supplementary Program (GRASP) Group | Active comparator | Other: Graded Repetitive Arm Supplementary Program (GRASP)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 |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 21-90 years regardless of lesion size, race
- Stroke type: ischemic or haemorrhagic
- Medically stable conditions
- Fugl-Meyer Assessment (FMA) of upper extremity impairment from 8-47 out of 66, or FMA of upper extremity impairment from 48-56 out of 66 if hand and wrist subscale is not full score and may still potentially benefit from study programme.
- Able to give own consent, comprehend and follow commands
Key exclusion criteria (6 listed)
- Recurrent stroke
- Unstable medical conditions (e.g. heart attack, unstable blood pressure, infection, and etc.) or anticipated life expectancy of <1 year.
- Significant cognitive and communicative impairment (e.g. severe receptive aphasia, inattention, learning difficulty, and etc).
- History of severe depression or active psychiatric disorder.
- Severe spasticity (Modified Ashworth scale >3) of the affected distal muscles, joint contractures or deformity, poor skin conditions (e.g. irritated skin, open wounds), amputation of fingers, and allergic condition (e.g. patients with allergies to adhesive gel).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsoGLOVEThe dose is referred to the stay of inpatient setting. The stroke patients will be transferred to community hospital when medically stable. The average of stay in community hospital is 3 weeks. The stroke patients will receive intensive stroke rehabilitation during the stay, which will be daily physiotherapy and occupational therapy. The subjects will receive EsoGLOVE training on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day, up to 15 sessions. This is similar to the dose in a similar trial (DSRB 2017/00312, Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture). | Device | EsoGLOVE |
| Graded Repetitive Arm Supplementary Program (GRASP)Graded Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day. | Other | Graded Repetitive Arm Supplementary Program (GRASP) Group |
Primary outcome
Fugl-Meyer Assessment for the Upper Extremity
Time frame: Baseline, immediately post-intervention and 3 months post-intervention
upper limb impairment scale ranged from 0-66 with higher score indicating better outcome
3 secondary outcomes
Stroke Impact Scale-16
Time frame: Baseline, immediately post-intervention and 3 months post-intervention
Stroke Upper Limb Capacity Scale
Time frame: Baseline, immediately post-intervention and 3 months post-intervention
Duruoz Hand Index
Time frame: Baseline, immediately post-intervention and 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pui Kit Tam, MBBS principal investigator
Alexandra Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EsoGLOVE and Graded Repetitive Arm Supplementary Program (GRASP) in people with Stroke, run by Alexandra Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment for the Upper Extremity (time frame: Baseline, immediately post-intervention and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.