Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients

Stroke Clinical Trial

Official title: Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients

Status Not yet recruiting

Clinical Trial Summary

Stroke remains the 4th cause of death in Singapore and despite advances in medical care and rehabilitation, 40-50% of stroke survivors are left with permanent disability and reduced quality of life. Hand motor impairment is a very serious complication to every stroke survivor. These impairments include difficulty moving and coordinating the hands and fingers, which inhibits stroke patients from being able to perform daily functional tasks independently, resulting in a reduced quality of life.

More than half of people with upper limb impairment after stroke will still have problems many months to years after their stroke. Therefore, improving hand function is a core element of rehabilitation where the aim is to recover and recruit the damaged neurons in the brain as soon as possible, within 3-6 months of the stroke as it thought to be the golden recovery period.

In the hospital setting, every stroke patient will receive about 30 minutes to 1 hour of occupational therapy (OT) for functional training, including hand functional exercises. However, manpower constraints limited stroke patients to one OT session per day but they are encouraged to continuously practice on their own, which may cause patients to encounter difficulties without guidance and hence less motivated to perform.

This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE with Trigno Biofeedback (EMG sensors) in the inpatient rehabilitation setting through:

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.

The investigators hypothesize that EsoGLOVE with Trigno Biofeedback (EMG sensors) combined with hand rehabilitation will add additional benefits to stroke patients. It might have better hand functional outcomes than hand rehabilitation alone as it can allow the patients to conduct functional task training in both passive and active modes.

Clinical Trial Description

Stroke remains the 4th cause of death in Singapore and despite advances in medical care and rehabilitation, 40-50% of stroke survivors are left with permanent disability and reduced quality of life. Given a global aging population and growing manpower constraints, the therapists-to-patients ratio will likely be inadequate. In the local context, Singapore is moving towards an aging population, where the number of elderly is expected to triple to 900,000 by 2030 with a decreasing old-age support ratio and is likely to be associated with increased risk of stroke and related motor disabilities.

Hand motor impairment is a very serious complication to every stroke survivor. These impairments include difficulty moving and coordinating the hands and fingers, which inhibits stroke patients from being able to perform daily functional tasks independently, resulting in a reduced quality of life. More than half of people with upper limb impairment after stroke will still have problems many months to years after their stroke. Therefore, improving hand function is a core element of rehabilitation.

Early rehabilitation is very essential to acute stroke patients. Most of the patients receive early rehabilitation in acute hospital and community hospital after suffering the stroke. The aim is to recover and recruit the damaged neurons in the brain as soon as possible. People believe that patients should start intensive rehabilitation within 3-6 months as the golden recovery period. In the hospital setting, every stroke patient will receive occupational therapy for functional training, including hand functional exercises. One therapy session is about 30 minutes to 1 hour. Due to manpower constraints, stroke patients may receive one session per day only. Patients may rest in the ward or the bed whole day after the therapy session. Bed exercises may be provided by therapists and encouraging patients to continuously practice while resting in the bed, however, patients may feel difficult without guidance and low motivation to perform. Hence this research is important for:

1. Assessing the efficacy of the EsoGLOVE with Trigno Biofeedback (EMG sensors) for acute and subacute stroke patients in the inpatient rehabilitation setting.

2. Investigating the efficacy of the EsoGLOVE with Trigno Biofeedback (EMG sensors): To achieve a minimum of 6 FMA scores difference/change between treatments and pre amp; post-intervention (3rd -0th week).

3. Understanding the ability and clinical outcome of the EsoGLOVE with Trigno Biofeedback (EMG sensors) in providing CPM exercise and assisting stroke patients with completing hand functional tasks, eventually improve patients' motor function and neural recovery.

4. Generating 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.

This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE with Trigno Biofeedback (EMG sensors) in the inpatient rehabilitation setting through:

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.

The investigators hypothesize that EsoGLOVE with Trigno Biofeedback (EMG sensors) combined with hand rehabilitation will add additional benefits to stroke patients. It might have better hand functional outcomes than hand rehabilitation alone as it can allow the patients to conduct functional task training in both passive and active modes. ;

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT05494489
• Study type: Interventional
• Source: National University Hospital, Singapore
• Contact: Pui Kit Tam, MD
• Phone: +65 8481 7399
• Email: pui_kit_tam@nuhs.edu.sg
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2022
• Completion date: June 29, 2023