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Completed

NCT Number: NCT04330417

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-Assisted Hand Training

Device

Perform activities of daily living, e.g., write sentences, turn cards, move small and big objects, simulated feeding, stack checkers, pour water, squeeze handles

Standard Hand Therapy

Other

Stretching, Strengthening, Hand Functional Training

Primary outcomes

  1. 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.

  2. Functional Assessment

    Time frame: Change from Baseline ARAT score at 6 weeks.

    Action Research Arm Test (ARAT), A total of 57 scores.

  3. Brain Imaging

    Time frame: Change from Baseline Imaging at 6 weeks.

    Functional Magnetic Resonance Imaging

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National University of Singapore

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2020
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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