Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients

NCT05995665 | Completed

• 1 other identifier: 2020/01105
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment for the Upper Extremity

  upper limb impairment scale ranged from 0-66 with higher score indicating better outcome

  Baseline, immediately post-intervention and 3 months post-intervention

Secondary Outcomes (3)

• Stroke Impact Scale-16

  Baseline, immediately post-intervention and 3 months post-intervention

• Stroke Upper Limb Capacity Scale

  Baseline, immediately post-intervention and 3 months post-intervention

• Duruoz Hand Index

  Baseline, immediately post-intervention and 3 months post-intervention

Study Arms (2)

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

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

Other: Graded Repetitive Arm Supplementary Program (GRASP)

Interventions

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.

Graded Repetitive Arm Supplementary Program (GRASP) Group

EsoGLOVE DEVICE

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).

EsoGLOVE

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandra Hospital: lead
• Roceso Technologies: collaborator
• Jurong Community Hospital, Singapore: collaborator

Study Sites (2)

Alexandra Hospital

Singapore, Singapore

Location

Jurong Community Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pui Kit Tam, MBBS

  Alexandra Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: July 11, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)