Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients

NCT05995665 | Unknown

• 1 other identifier: 2020/01105
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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 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 - Upper Extremity (FMA-UE)

  To achieve minimum of 6 FMA-UE scores difference/change between treatments and pre \& post intervention (3th - 0th week).

  2 years

Study Arms (2)

EsoGLOVE with Trigno Biofeedback (EMG sensors) group

EXPERIMENTAL

The EsoGLOVE + Trigno Biofeedback Group 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

Device: EsoGLOVE with Trigno Biofeedback (EMG sensors)

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

EsoGLOVE with Trigno Biofeedback (EMG sensors) 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 EsoGLOVETM with Trigno Biofeedback (EMG sensors) training on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day. A total of 15 sessions (5 session per week for a total of 3 weeks) of a minimum of 30 mins. 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 with Trigno Biofeedback (EMG sensors) group

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

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 30-90 years regardless of lesion size, race
• Stroke type: ischemic or haemorrhagic
• Medically stable conditions
• Fugl-Meyer Assessment (FMA) of upper extremity impairment of 10-56 out of 66.
• Able to give own consent, comprehend and follow commands
• Able to sit upright and maintain sitting balance for at least 30 minutes
• Able to stay alert and focus on the tasks at least 30 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.
• 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 ≥2), 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
• Jurong Community Hospital, Singapore: collaborator
• Roceso Technologies: collaborator

Study Sites (2)

Alexandra Hospital

Singapore, Singapore

RECRUITING

Jurong Community Hospital

Singapore, Singapore

RECRUITING

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

Central Study Contacts

Pui Kit Tam, MBBS

CONTACT

+65 -6779 5555; pui_kit_tam@nuhs.edu.sg

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: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)