StrokeNCT04330417
Bidirectional Myoelectric (BIMYO) Soft Robotic Glove Technology For Robot-Assisted Hand Therapy in Stroke Patients
A study testing Robot-Assisted Hand Training and Standard Hand Therapy in people with Stroke, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-Assisted Hand Training and Standard Hand Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Oct 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Robot-Assisted Hand Training, Standard Hand Therapy
- Keywords
- Stroke, Soft Robotic Glove, Electromyography, Hand Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Hand TrainingDevice
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 TherapyOther
Stretching, Strengthening, Hand Functional Training
| Study group | Role | What they receive |
|---|---|---|
| EMG Glove Group | Experimental | A total of 12 sessions of robot-assisted hand training for 6 consecutive weeks. Receives: Device: Robot-Assisted Hand Training |
| Control Group | Active comparator | A total of 12 session of standard hand therapy sessions in 6 consecutive weeks. Receives: Other: Standard Hand Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment
Fugl-Meyer Assessment (FMA) Upper Extremity (UE) Score, A total of 66 scores.
Measured: Change from Baseline FMA score at 6 weeks.
Functional Assessment
Action Research Arm Test (ARAT), A total of 57 scores.
Measured: Change from Baseline ARAT score at 6 weeks.
Brain Imaging
Functional Magnetic Resonance Imaging
Measured: Change from Baseline Imaging at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start13 Oct 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330417
- Sponsor's protocol ID
- 2018/01258
- Other IDs
- 2018
- Status last verified
- Mar 2022
- First submitted
- 24 Apr 2019
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29062267Koh 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.
PubMed 29118693
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bidirectional Myoelectric (BIMYO) Soft Robotic Glove Technology For Robot-Assisted Hand Therapy in Stroke Patients
- ClinicalTrials.gov ID
- NCT04330417
- Acronym / sponsor ID
- 2018/01258
- Conditions
- Stroke
- Keywords
- Stroke, Soft Robotic Glove, Electromyography, Hand Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMG Glove Group | Experimental | Device: Robot-Assisted Hand TrainingA total of 12 sessions of robot-assisted hand training for 6 consecutive weeks. |
| Control Group | Active comparator | Other: Standard Hand TherapyA total of 12 session of standard hand therapy sessions in 6 consecutive weeks. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Assisted Hand TrainingPerform activities of daily living, e.g., write sentences, turn cards, move small and big objects, simulated feeding, stack checkers, pour water, squeeze handles | Device | EMG Glove Group |
| Standard Hand TherapyStretching, Strengthening, Hand Functional Training | Other | Control Group |
Primary outcome
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.
Functional Assessment
Time frame: Change from Baseline ARAT score at 6 weeks.
Action Research Arm Test (ARAT), A total of 57 scores.
Brain Imaging
Time frame: Change from Baseline Imaging at 6 weeks.
Functional Magnetic Resonance Imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 29062267Yap 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.
- Background: PubMed 29118693Koh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Hand Training and Standard Hand Therapy in people with Stroke, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment (time frame: Change from Baseline FMA score at 6 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330417, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.