Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients

Stroke Clinical Trial

Official title:

Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05494489
• Other study ID #: 2020/01105
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: June 29, 2023

Study information

• Verified date: August 2022
• Source: National University Hospital, Singapore
• Contact: Pui Kit Tam, MD
• Phone: +65 8481 7399
• Email: pui_kit_tam[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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 for at least 30 minutes and more.

• Unilateral upper limb impairment

Exclusion Criteria:

• 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 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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• EsoGLOVE with Trigno Biofeedback (EMG sensors)
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 in additional to the physiotherapy and occupational therapy as standard care for stroke patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

References & Publications (3)

Cheng N, Phua KS, Lai HS, Tam PK, Tang KY, Cheng KK, Yeow RC, Ang KK, Guan C, Lim JH. Brain-Computer Interface-Based Soft Robotic Glove Rehabilitation for Stroke. IEEE Trans Biomed Eng. 2020 Dec;67(12):3339-3351. doi: 10.1109/TBME.2020.2984003. Epub 2020 Nov 19. — View Citation

Nasrallah FA, Mohamed AZ, Campbell ME, Yap HK, Yeow CH, Lim JH. Functional connectivity of brain associated with passive range of motion exercise: Proprioceptive input promoting motor activation? Neuroimage. 2019 Nov 15;202:116023. doi: 10.1016/j.neuroimage.2019.116023. Epub 2019 Jul 17. — View Citation

Yap HK, Lim JH, Nasrallah F, Yeow CH. Design and Preliminary Feasibility Study of a Soft Robotic Glove for Hand Function Assistance in Stroke Survivors. Front Neurosci. 2017 Oct 9;11:547. doi: 10.3389/fnins.2017.00547. eCollection 2017. Erratum in: Front Neurosci. 2018 May 08;12 :323. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Upper Extremity Scale (FML-UE)	The Fugl-Meyer Upper Extremity (FMUE) is a 33 item scale used for assessing re?ex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. Each item is scored from 0 to 2, where 0 = cannot perform, 1 = performs partially and2 = performs fully. Total scores for all items ranges form 0 to 66, where higher scores indicates better functioning of the upper limb and lower scores indicates decreased function in the affected upper limb. The FML-UE scale is administered at different time points to track patients' improvements of the affected upper limb in stroke patients.	Baseline assessment
Primary	Fugl-Meyer Upper Extremity Scale (FML-UE)	The Fugl-Meyer Upper Extremity (FMUE) is a 33 item scale used for assessing re?ex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. Each item is scored from 0 to 2, where 0 = cannot perform, 1 = performs partially and2 = performs fully. Total scores for all items ranges form 0 to 66, where higher scores indicates better functioning of the upper limb and lower scores indicates decreased function in the affected upper limb. The FML-UE scale is administered at different time points to track patients' improvements of the affected upper limb in stroke patients.	Post-intervention assessment at day 15.
Primary	Fugl-Meyer Upper Extremity Scale (FML-UE)	The Fugl-Meyer Upper Extremity (FMUE) is a 33 item scale used for assessing re?ex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. Each item is scored from 0 to 2, where 0 = cannot perform, 1 = performs partially and2 = performs fully. Total scores for all items ranges form 0 to 66, where higher scores indicates better functioning of the upper limb and lower scores indicates decreased function in the affected upper limb. The FML-UE scale is administered at different time points to track patients' improvements of the affected upper limb in stroke patients.	Post-intervention assessment at 3 month follow up visit
Primary	Stroke Impact Scale (SIS)	The Stroke Impact Scale (SIS) is a 59 item, self-reporting questionnaire for assessing disability and health-related quality of life (QoL) after stroke in 8 domains, namely: 1. Strength, 2. Hand function, 3. Activities of daily living (ADL/IADL), 4. Mobility, 5. Communication, 6. Emotion, 7. Memory and thinking, 8. Participation/Role function. The individual items are total scores to give a range of 0 to 100, where higher scores indicates better functioning.	Baseline assessment
Primary	Stroke Impact Scale (SIS)	The Stroke Impact Scale (SIS) is a 59 item, self-reporting questionnaire for assessing disability and health-related quality of life (QoL) after stroke in 8 domains, namely: 1. Strength, 2. Hand function, 3. Activities of daily living (ADL/IADL), 4. Mobility, 5. Communication, 6. Emotion, 7. Memory and thinking, 8. Participation/Role function. The individual items are total scores to give a range of 0 to 100, where higher scores indicates better functioning.	Post-intervention assessment at 21 days
Primary	Stroke Impact Scale (SIS)	The Stroke Impact Scale (SIS) is a 59 item, self-reporting questionnaire for assessing disability and health-related quality of life (QoL) after stroke in 8 domains, namely: 1. Strength, 2. Hand function, 3. Activities of daily living (ADL/IADL), 4. Mobility, 5. Communication, 6. Emotion, 7. Memory and thinking, 8. Participation/Role function. The individual items are total scores to give a range of 0 to 100, where higher scores indicates better functioning and is administered at different time points to track improvements in patients.	Post-intervention assessment at 3 months follow-up
Primary	Duruoz Hand Index	The Duruoz Hand Index is a 18-item self-reporting questionnaire for evaluating activity limitations of the hand in terms of level of difficulties in carrying out manual tasks independently in 5 domains, namely: 1. in the kitchen, 2. dressing, 3. hygiene, 4. in the, office and 5. Other. Each item is rated on a 6 point Likert scale, where 0 = without difficulty and 5 = impossible. All the responses are totaled score of between 0 to 90 where higher scores represents poorer functioning of the affected hand. The Duroz Hand Index is administered at different time points to track improvements in the patient's level of functioning.	Baseline assessment
Primary	Duruoz Hand Index	The Duruoz Hand Index is a 18-item self-reporting questionnaire for evaluating activity limitations of the hand in terms of level of difficulties in carrying out manual tasks independently in 5 domains, namely: 1. in the kitchen, 2. dressing, 3. hygiene, 4. in the, office and 5. Other. Each item is rated on a 6 point Likert scale, where 0 = without difficulty and 5 = impossible. All the responses are totaled score of between 0 to 90 where higher scores represents poorer functioning of the affected hand. The Duroz Hand Index is administered at different time points to track improvements in the patient's level of functioning.	Post-intervention assessment at 21 days
Primary	Duruoz Hand Index	The Duruoz Hand Index is a 18-item self-reporting questionnaire for evaluating activity limitations of the hand in terms of level of difficulties in carrying out manual tasks independently in 5 domains, namely: 1. in the kitchen, 2. dressing, 3. hygiene, 4. in the, office and 5. Other. Each item is rated on a 6 point Likert scale, where 0 = without difficulty and 5 = impossible. All the responses are totaled score of between 0 to 90 where higher scores represents poorer functioning of the affected hand. The Duroz Hand Index is administered at different time points to track improvements in the patient's level of functioning.	Post-intervention assessment 3 months follow up
Primary	Stroke Upper Limb Capacity Scale (SULCS)	The SULCS consists of 10 tasks that relate to daily activities.1,3 Each receives a score of 0 (unable to perform) or 1 (able to perform), resulting in a total score of 0-10 where higher scores indicates better functioning of the stroke-affected upper limb. This scale is administered at different time points to assess the improvements in upper limb affected by stroke.	Baseline assessment
Primary	Stroke Upper Limb Capacity Scale (SULCS)	The SULCS consists of 10 tasks that relate to daily activities.1,3 Each receives a score of 0 (unable to perform) or 1 (able to perform), resulting in a total score of 0-10 where higher scores indicates better functioning of the stroke-affected upper limb. This scale is administered at different time points to assess the improvements in upper limb affected by stroke.	Post-intervention assessment at 21 days follow up
Primary	Stroke Upper Limb Capacity Scale (SULCS)	The SULCS consists of 10 tasks that relate to daily activities.1,3 Each receives a score of 0 (unable to perform) or 1 (able to perform), resulting in a total score of 0-10 where higher scores indicates better functioning of the stroke-affected upper limb. This scale is administered at different time points to assess the improvements in upper limb affected by stroke.	Post-intervention assessment at 3 months follow up
Primary	Out-of-Pocket Spending Questionnaire	Out-of-Pocket Spending is defined as direct payments made by individuals to health care providers at the time of service use. The Out-of-Pocket Spending Questionnaire will record out-of-pocket spending the patient has made from Week 3 to 12.	Post-intervention assessment at 3 month follow up visit only