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Bidirectional Myoelectric (BIMYO) Soft Robotic Glove Technology For Robot-Assisted Hand Therapy in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Robot-Assisted Hand Training
Standard Hand Therapy
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Stroke, Soft Robotic Glove, Electromyography, Hand Rehabilitation

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 30-90 years regardless of lesion size, race
  2. Stroke type: ischemic or haemorrhagic
  3. Fugl-Meyer Assessment (FMA) of upper extremity impairment of 10-56 out of a maximum score of 66 on the Fugl-Meyer assessment scale
  4. Able to comprehend and follow commands
  5. Unilateral upper limb impairment

Exclusion Criteria:

  1. Recurrent stroke
  2. Unstable medical conditions or anticipated life expectancy of <1 year
  3. History of severe depression or active psychiatric disorder
  4. Severe spasticity (Modified Ashworth scale >2)
  5. Poor skin condition

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EMG Glove Group

Control Group

Arm Description

A total of 12 sessions of robot-assisted hand training for 6 consecutive weeks.

A total of 12 session of standard hand therapy sessions in 6 consecutive weeks.

Outcomes

Primary Outcome Measures

Functional Assessment
Fugl-Meyer Assessment (FMA) Upper Extremity (UE) Score, A total of 66 scores.
Functional Assessment
Action Research Arm Test (ARAT), A total of 57 scores.
Brain Imaging
Functional Magnetic Resonance Imaging

Secondary Outcome Measures

Full Information

First Posted
April 24, 2019
Last Updated
March 3, 2022
Sponsor
National University Hospital, Singapore
Collaborators
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT04330417
Brief Title
Bidirectional Myoelectric (BIMYO) Soft Robotic Glove Technology For Robot-Assisted Hand Therapy in Stroke Patients
Official Title
Bidirectional Myoelectric (BIMYO) Soft Robotic Glove Technology For Robot-Assisted Hand Therapy in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Stroke patients have limited hand mobility post-stroke, thus inhibiting them from performing daily functional tasks independently, resulting in reduced quality of life. Current hand rehabilitation robotic devices are typically driven by rigid linkages/joints, which subject the fingers into a single plane of motion that is unnatural and uncomfortable. These devices belong to the class of continuous passive motion (CPM) devices that only promote hand range-of-motion, but do not require the patient to play an active role in performing the hand exercises. There is a strong need for a device that can resolve the lack of compliant robot-assisted hand motion and lack of intuitive user control in assistive and rehabilitation processes. This proposed research aims to fill the above-mentioned gaps for current hand rehabilitation devices by developing a soft robotic glove that provides compliant assistance to bidirectional hand motion, coupled with intuitive user control. In the short term, the robotic glove will likely enhance the patients' hand flexion-extension range of motion and improve the neuro-motor control of the hand. In the long term, the robotic glove will act as an adjunct to therapists, thereby raising productivity in the presence of growing manpower constraints and optimizing therapy time for the patients; this can potentially enhance recovery time and quality of life, as a result of improved hand mobility for common daily tasks.
Detailed Description
The investigators aim to develop a new bidirectional composite soft actuator that is capable of assisting in both hand flexion and extension. This new class of actuator will comprise of a flexion actuator component with its external bending patterns and dedicated pneumatic channel, and an embedded extension actuator component with its dedicated air-flow inlet. When pressurized air is introduced through the extension inlet, the extension actuator will inflate and stiffen, thereby assisting in hand extension. Moreover, when pressurized air is introduced through the flexion inlet, the flexion actuator will inflate and bend, thereby assisting in hand flexion. These bidirectional actuators will be embedded onto each finger segment of a fabric glove, and air inflow into each of the bidirectional actuators can be controlled via a pump-valve control system. The pump-valve control system comprises a microcontroller, onboard power source, transceiver, motor pump, and flexion and extension control valves. Once the microcontroller receives a command signal to adopt a specific hand posture, it will send the postural command to the motor pump and the necessary flexion/extension control valves, thereby actuating the corresponding bidirectional soft actuators to assist the user's hand into the desired hand posture. Aims: Aim 1: The bidirectional myoelectric soft robotic glove may provide intuitive user-controlled robot-assisted hand grasping postures to the human user for achieving functional tasks. With the help of the glove system, participants may be more capable of achieving active daily living tasks. Aim 2: The bidirectional myoelectric soft robotic glove may provide intuitive user-controlled robot-assisted hand grasping postures to the human user for rehabilitation purposes. Hypothesis: The central hypothesis is that a bidirectional myoelectric soft robotic glove will provide intuitive user-controlled robot-assisted hand grasping postures to the human user for achieving functional tasks more than no robot assistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Soft Robotic Glove, Electromyography, Hand Rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMG Glove Group
Arm Type
Experimental
Arm Description
A total of 12 sessions of robot-assisted hand training for 6 consecutive weeks.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
A total of 12 session of standard hand therapy sessions in 6 consecutive weeks.
Intervention Type
Device
Intervention Name(s)
Robot-Assisted Hand Training
Intervention Description
Perform activities of daily living, e.g., write sentences, turn cards, move small and big objects, simulated feeding, stack checkers, pour water, squeeze handles
Intervention Type
Other
Intervention Name(s)
Standard Hand Therapy
Intervention Description
Stretching, Strengthening, Hand Functional Training
Primary Outcome Measure Information:
Title
Functional Assessment
Description
Fugl-Meyer Assessment (FMA) Upper Extremity (UE) Score, A total of 66 scores.
Time Frame
Change from Baseline FMA score at 6 weeks.
Title
Functional Assessment
Description
Action Research Arm Test (ARAT), A total of 57 scores.
Time Frame
Change from Baseline ARAT score at 6 weeks.
Title
Brain Imaging
Description
Functional Magnetic Resonance Imaging
Time Frame
Change from Baseline Imaging at 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 30-90 years regardless of lesion size, race Stroke type: ischemic or haemorrhagic Fugl-Meyer Assessment (FMA) of upper extremity impairment of 10-56 out of a maximum score of 66 on the Fugl-Meyer assessment scale Able to comprehend and follow commands Unilateral upper limb impairment Exclusion Criteria: Recurrent stroke Unstable medical conditions or anticipated life expectancy of <1 year History of severe depression or active psychiatric disorder Severe spasticity (Modified Ashworth scale >2) Poor skin condition
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
29062267
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.
Results Reference
background
PubMed Identifier
29118693
Citation
Koh TH, Cheng N, Yap HK, Yeow CH. Design of a Soft Robotic Elbow Sleeve with Passive and Intent-Controlled Actuation. Front Neurosci. 2017 Oct 25;11:597. doi: 10.3389/fnins.2017.00597. eCollection 2017.
Results Reference
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Bidirectional Myoelectric (BIMYO) Soft Robotic Glove Technology For Robot-Assisted Hand Therapy in Stroke Patients

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