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

March 3, 2022 updated by: National University Hospital, Singapore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMG Glove Group
A total of 12 sessions of robot-assisted hand training for 6 consecutive weeks.
Device: Robot-Assisted Hand Training
Perform activities of daily living, e.g., write sentences, turn cards, move small and big objects, simulated feeding, stack checkers, pour water, squeeze handles
Active Comparator: Control Group
A total of 12 session of standard hand therapy sessions in 6 consecutive weeks.
Other: Standard Hand Therapy
Stretching, Strengthening, Hand Functional Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment
Time Frame: Change from Baseline FMA score at 6 weeks.
Fugl-Meyer Assessment (FMA) Upper Extremity (UE) Score, A total of 66 scores.
Change from Baseline FMA score at 6 weeks.
Functional Assessment
Time Frame: Change from Baseline ARAT score at 6 weeks.
Action Research Arm Test (ARAT), A total of 57 scores.
Change from Baseline ARAT score at 6 weeks.
Brain Imaging
Time Frame: Change from Baseline Imaging at 6 weeks.
Functional Magnetic Resonance Imaging
Change from Baseline Imaging at 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

National University, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/01258

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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