Viewing Study NCT04330417



Ignite Creation Date: 2024-05-06 @ 2:30 PM
Last Modification Date: 2024-10-26 @ 1:31 PM
Study NCT ID: NCT04330417
Status: COMPLETED
Last Update Posted: 2022-03-04
First Post: 2019-04-24

Brief Title: Bidirectional Myoelectric BIMYO Soft Robotic Glove Technology For Robot-Assisted Hand Therapy in Stroke Patients
Sponsor: National University Hospital Singapore
Organization: National University Hospital Singapore

Study Overview

Official Title: Bidirectional Myoelectric BIMYO Soft Robotic Glove Technology For Robot-Assisted Hand Therapy in Stroke Patients
Status: COMPLETED
Status Verified Date: 2022-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 linkagesjoints 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 flexionextension control valves thereby actuating the corresponding bidirectional soft actuators to assist the users 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None