StrokeNCT03277508
Assistive Soft Robotic Glove Intervention Using Brain-Computer Interface for Elderly Stroke Patients
A study testing BCI Robot Assisted Hand Therapy and CPM Robot Assisted Hand Therapy in people with Stroke, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This research aims to integrate and develop a novel Brain-Computer Interface (BCI) controlled soft robotic glove, evaluate the ability of the glove in achieving common hand grasping postures and to assess the efficacy of the glove in assisting stroke patients with completing functional tasks. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- BCI Robot Assisted Hand Therapy and CPM Robot Assisted Hand Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Mar 2018to 22 Apr 2019
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 55-90 years regardless of lesion size, race
- History of stroke less than 3 months prior to participation
- Stroke type: ischemic or haemorrhagic
- Fugl-Meyer motor score (FM score) of upper extremity impairment of 0-45 out of a maximum score of 66 on the Fugl-Meyer assessment scale
- Ability to pay attention and maintain supported sitting for 1.5 hours continuously
- Lack of or poor hand mobility (Medical Research Council Grade ≤ 2/5)
Show all 10Show fewer
- Able to give own consent
- Able to comprehend and follow commands (Abbreviated Mental Test equal or more than 7)
- Fulfil BCI resting brain states on initial screening.
- Unilateral upper limb impairment
Who cannot join
- Recurrent clinical stroke
- Functional status: severe aphasia or inattention, unstable medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder)
- Hemispatial neglect (visual or sensory) or severe visual impairment despite visual aids
- History of severe depression or active psychiatric disorder
- Skull defect or previous cranial surgery as this would affect physical fit of EEG cap interface
- Local arm factors: severe spasticity Modified Ashworth scale >1+ in any region, fixed joint contractures or joint replacements, patients with poor skin conditions which would contraindicate repetitive arm training, upper limb pain impeding movements with visual analogue scale (VAS score) >4/10, other conditions ensuing upper limb weakness, skull defect, polydactyly or amputation of fingers, and allergy to electrodes or adhesive gel
Trial locations and contacts
1 site in 1 country.
About this study
This research aims to integrate and develop a novel Brain-Computer Interface (BCI) controlled soft robotic glove, evaluate the ability of the glove in achieving common hand grasping postures and to assess the efficacy of the glove in assisting stroke patients with completing functional tasks. The BCI-controlled soft robotic glove utilizes patients' user intent to deliver specific electroencephalographic patterns that can trigger robot-assisted hand movement to the affected hand.
Read the detailed description
Hand motor impairment is very common after a stroke. These impairments include difficulty moving and coordinating the hands and fingers, which inhibits stroke patients from being able to perform daily functional tasks independently, resulting in a reduced quality of life. More than half of people with upper limb impairment after stroke will still have problems many months to years after their stroke. Therefore, improving hand function is a core element of rehabilitation. Many possible interventions have been developed; these may involve different exercises or training, specialist equipment or techniques, or they could take the form of a drug (pill or injection) given to help hand movement. There is limited evidence that suggests the following interventions may be effective: constraint-induced movement therapy, mental practice, mirror therapy,interventions for sensory impairment, virtual reality and a relatively high dose of repetitive task practice. Current hand rehabilitation robotic devices are typically driven by rigid linkages or joints, which subject the patient's fingers into a single plane of motion that will feel unnatural and uncomfortable. On top of that,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 a semi-active role in performing the hand exercises. Furthermore, there is a huge demand for solutions assisting stroke patients with using the densely paralyzed hand to perform activities of daily living (ADL) in real life, which is not available at present. Most of the hand rehabilitation robotic devices available in the market cannot assist paralyzed hand to carry out ADL. To develop an assistive device to solve this unmet need, we decided to combine BCI technology with the wearable soft robotic glove, which enables actuation of paralyzed hand by motor imagery.
- Conditions
- Stroke
- Being tested
- BCI Robot Assisted Hand Therapy, CPM Robot Assisted Hand Therapy
- Keywords
- Brain-computer integration
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI Robot Assisted Hand TherapyDevice
18 sessions (3 times per week for a total of 6 weeks) of 1.5 hours each training (60 minutes of BCI Robot and 30 minutes of the standard hand therapy).
Session 1-3. Peg game: Lateral movement of gears/cups Session 4-6. Moving cups onto a shelf: Elevation process for the arm, small cups to be used.
Session 7-9. Carrying of basket: Heavier load to be used, patient to hold the basket by the handles at the side, not by its base.
Session 10-12. Opening bottle + pouring into a cup: Training of ADL Session 13-15. Eating: Use of a modified spoon to train ADL Session 16-18. Box and blocks: Precise index finger and thumb control
CPM Robot Assisted Hand TherapyDevice
18 sessions (3 times per week for a total of 6 weeks) of 1.5 hours each training (60 minutes of Passive Robot and 30 minutes of the standard hand therapy).The procedure will include the following: Session 1-18: Continuous passive motion
| Study group | Role | What they receive |
|---|---|---|
| BCI robot assisted hand therapy | Experimental | Brain-computer integration robot assisted hand therapy Receives: Device: BCI Robot Assisted Hand Therapy |
| CPM robot assisted hand therapy | Active comparator | Continue Passive Movement robot assisted hand therapy Receives: Device: CPM Robot Assisted Hand Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation
Measured: 30 minutes
Fugl-Meyer Assessment
It is designed to assess motor functioning, balance, sensation and joint functioning.
Measured: 20 minutes
Grip Strength Test
The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start2 Mar 2018
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomization stratification method, with a computer generated random sequence will be used. Subjects will be grouped in strata according to their Fugl-Meyer scores(0-28 vs 29-45) and randomized separately according to a block randomization to receive either of following treatments:(1) Treatment A: 18 sessions for 6 weeks of 60 minutes of passive robot-assisted hand therapy+ 30 minutes of standard hand therapy.(2) Treatment B: 18 sessions for 6 weeks of 60 minutes of BCI controlled robot-assisted hand therapy + 30 minutes of standard hand therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore, Agency for Science, Technology and Research
- Responsible party
- Sponsor
- Investigators
- Jeong Hoon Lim, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277508
- Sponsor's protocol ID
- 2017/00312
- Other IDs
- 2017
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2017
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
F.Z. Low, H.K. Yap, J.H. Lim, F. Nasrallah, J.C.H. Goh, C.H. Yeow. Wearable Soft Robotics for Rehabilitation. 8th Asian Pacific Conference on Biomechanics 2015 (Sapporo).
H.K. Yap, F. Nasrahllah, J.H. Lim, F.Z. Low, J.C.H. Goh, C.H. Yeow. MRC-Glove: A fMRI Compatible Soft Robotic Glove for Hand Rehabilitation Application, 14th IEEE/RAS-EMBS International Conference on Rehabilitation Robotics (ICORR 2015).
H.K. Yap, J.H. Lim, F. Nasrahllah, J.C.H. Goh, C.H. Yeow. A Soft Exoskeleton for Hand Assistive and Rehabilitation Application Page 8 using Pneumatic Actuators with Variable Stiffness, in IEEE Int. Conf. Robotics and Automation 2015.
H.K. Yap, J.C.H. Goh, C.H. Yeow. Design and Characterization of Soft Actuator for Hand Rehabilitation Application. 6th European Conference of the International Federation for Medical and Biological Engineering (MBEC 2014)
H.K. Yap, J.H. Lim, F. Nasrallah, J.C.H. Goh, C.H. Yeow. Customizable Pneumatic Bending Actuator for Finger Rehabilitation. Design of Medical Devices Conference Europe 2014 (Delft)
C.H. Yeow, A.T. Baisch, S.G. Talbot, C.J. Walsh. Differential spring stiffness design for finger therapy exercise device: bio-inspired from stiff pathological finger joints. ASME Journal of Medical Devices 2012
Ang KK, Chin ZY, Wang C, Guan C, Zhang H. Filter Bank Common Spatial Pattern Algorithm on BCI Competition IV Datasets 2a and 2b. Front Neurosci. 2012 Mar 29;6:39. doi: 10.3389/fnins.2012.00039. eCollection 2012.
PubMed 22479236Ang KK, Guan C, Phua KS, Wang C, Zhao L, Teo WP, Chen C, Ng YS, Chew E. Facilitating effects of transcranial direct current stimulation on motor imagery brain-computer interface with robotic feedback for stroke rehabilitation. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S79-87. doi: 10.1016/j.apmr.2014.08.008.
PubMed 25721551Ang KK, Chua KS, Phua KS, Wang C, Chin ZY, Kuah CW, Low W, Guan C. A Randomized Controlled Trial of EEG-Based Motor Imagery Brain-Computer Interface Robotic Rehabilitation for Stroke. Clin EEG Neurosci. 2015 Oct;46(4):310-20. doi: 10.1177/1550059414522229. Epub 2014 Apr 21.
PubMed 24756025Ang KK, Guan C, Phua KS, Wang C, Zhou L, Tang KY, Ephraim Joseph GJ, Kuah CW, Chua KS. Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke. Front Neuroeng. 2014 Jul 29;7:30. doi: 10.3389/fneng.2014.00030. eCollection 2014.
PubMed 25120465Rojas JI, Zurru MC, Romano M, Patrucco L, Cristiano E. Acute ischemic stroke and transient ischemic attack in the very old--risk factor profile and stroke subtype between patients older than 80 years and patients aged less than 80 years. Eur J Neurol. 2007 Aug;14(8):895-9. doi: 10.1111/j.1468-1331.2007.01841.x.
PubMed 17662011Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.
PubMed 18086926Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.
PubMed 25520374Venketasubramanian N, Chen CL. Burden of stroke in Singapore. Int J Stroke. 2008 Feb;3(1):51-4. doi: 10.1111/j.1747-4949.2008.00181.x.
PubMed 18705915Hong Kai Yap, Kamaldin N, Jeong Hoon Lim, Nasrallah FA, Goh JCH, Chen-Hua Yeow. A Magnetic Resonance Compatible Soft Wearable Robotic Glove for Hand Rehabilitation and Brain Imaging. IEEE Trans Neural Syst Rehabil Eng. 2017 Jun;25(6):782-793. doi: 10.1109/TNSRE.2016.2602941. Epub 2016 Aug 25.
PubMed 28113591
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistive Soft Robotic Glove Intervention Using Brain-Computer Interface for Elderly Stroke Patients
- ClinicalTrials.gov ID
- NCT03277508
- Acronym / sponsor ID
- 2017/00312
- Conditions
- Stroke
- Keywords
- Brain-computer integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore, Agency for Science, Technology and Research
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 11 Sep 2017 (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.
This research aims to integrate and develop a novel Brain-Computer Interface (BCI) controlled soft robotic glove, evaluate the ability of the glove in achieving common hand grasping postures and to assess the efficacy of the glove in assisting stroke patients with completing functional tasks. The BCI-controlled soft robotic glove utilizes patients' user intent to deliver specific electroencephalographic patterns that can trigger robot-assisted hand movement to the affected hand.
Detailed description
Hand motor impairment is very common after a stroke. These impairments include difficulty moving and coordinating the hands and fingers, which inhibits stroke patients from being able to perform daily functional tasks independently, resulting in a reduced quality of life. More than half of people with upper limb impairment after stroke will still have problems many months to years after their stroke. Therefore, improving hand function is a core element of rehabilitation. Many possible interventions have been developed; these may involve different exercises or training, specialist equipment or techniques, or they could take the form of a drug (pill or injection) given to help hand movement. There is limited evidence that suggests the following interventions may be effective: constraint-induced movement therapy, mental practice, mirror therapy,interventions for sensory impairment, virtual reality and a relatively high dose of repetitive task practice. Current hand rehabilitation robotic devices are typically driven by rigid linkages or joints, which subject the patient's fingers into a single plane of motion that will feel unnatural and uncomfortable. On top of that,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 a semi-active role in performing the hand exercises. Furthermore, there is a huge demand for solutions assisting stroke patients with using the densely paralyzed hand to perform activities of daily living (ADL) in real life, which is not available at present. Most of the hand rehabilitation robotic devices available in the market cannot assist paralyzed hand to carry out ADL. To develop an assistive device to solve this unmet need, we decided to combine BCI technology with the wearable soft robotic glove, which enables actuation of paralyzed hand by motor imagery.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomization stratification method, with a computer generated random sequence will be used. Subjects will be grouped in strata according to their Fugl-Meyer scores(0-28 vs 29-45) and randomized separately according to a block randomization to receive either of following treatments:(1) Treatment A: 18 sessions for 6 weeks of 60 minutes of passive robot-assisted hand therapy+ 30 minutes of standard hand therapy.(2) Treatment B: 18 sessions for 6 weeks of 60 minutes of BCI controlled robot-assisted hand therapy + 30 minutes of standard hand therapy.
| Arm | Type | Receives |
|---|---|---|
| BCI robot assisted hand therapy | Experimental | Device: BCI Robot Assisted Hand TherapyBrain-computer integration robot assisted hand therapy |
| CPM robot assisted hand therapy | Active comparator | Device: CPM Robot Assisted Hand TherapyContinue Passive Movement robot assisted hand therapy |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 55-90 years regardless of lesion size, race
- History of stroke less than 3 months prior to participation
- Stroke type: ischemic or haemorrhagic
- Fugl-Meyer motor score (FM score) of upper extremity impairment of 0-45 out of a maximum score of 66 on the Fugl-Meyer assessment scale
- Ability to pay attention and maintain supported sitting for 1.5 hours continuously
Key exclusion criteria (6 listed)
- Recurrent clinical stroke
- Functional status: severe aphasia or inattention, unstable medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder)
- Hemispatial neglect (visual or sensory) or severe visual impairment despite visual aids
- History of severe depression or active psychiatric disorder
- Skull defect or previous cranial surgery as this would affect physical fit of EEG cap interface
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 |
|---|---|---|
| BCI Robot Assisted Hand Therapy18 sessions (3 times per week for a total of 6 weeks) of 1.5 hours each training (60 minutes of BCI Robot and 30 minutes of the standard hand therapy). Session 1-3. Peg game: Lateral movement of gears/cups Session 4-6. Moving cups onto a shelf: Elevation process for the arm, small cups to be used. Session 7-9. Carrying of basket: Heavier load to be used, patient to hold the basket by the handles at the side, not by its base. Session 10-12. Opening bottle + pouring into a cup: Training of ADL Session 13-15. Eating: Use of a modified spoon to train ADL Session 16-18. Box and blocks: Precise index finger and thumb control | Device | BCI robot assisted hand therapy |
| CPM Robot Assisted Hand Therapy18 sessions (3 times per week for a total of 6 weeks) of 1.5 hours each training (60 minutes of Passive Robot and 30 minutes of the standard hand therapy).The procedure will include the following: Session 1-18: Continuous passive motion | Device | CPM robot assisted hand therapy |
Primary outcome
Action Research Arm Test
Time frame: 30 minutes
It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation
Fugl-Meyer Assessment
Time frame: 20 minutes
It is designed to assess motor functioning, balance, sensation and joint functioning.
Grip Strength Test
Time frame: 5 minutes
The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles.
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 30 Apr 2019.
- BackgroundF.Z. Low, H.K. Yap, J.H. Lim, F. Nasrallah, J.C.H. Goh, C.H. Yeow. Wearable Soft Robotics for Rehabilitation. 8th Asian Pacific Conference on Biomechanics 2015 (Sapporo).
- BackgroundH.K. Yap, F. Nasrahllah, J.H. Lim, F.Z. Low, J.C.H. Goh, C.H. Yeow. MRC-Glove: A fMRI Compatible Soft Robotic Glove for Hand Rehabilitation Application, 14th IEEE/RAS-EMBS International Conference on Rehabilitation Robotics (ICORR 2015).
- BackgroundH.K. Yap, J.H. Lim, F. Nasrahllah, J.C.H. Goh, C.H. Yeow. A Soft Exoskeleton for Hand Assistive and Rehabilitation Application Page 8 using Pneumatic Actuators with Variable Stiffness, in IEEE Int. Conf. Robotics and Automation 2015.
- BackgroundH.K. Yap, J.C.H. Goh, C.H. Yeow. Design and Characterization of Soft Actuator for Hand Rehabilitation Application. 6th European Conference of the International Federation for Medical and Biological Engineering (MBEC 2014)
- BackgroundH.K. Yap, J.H. Lim, F. Nasrallah, J.C.H. Goh, C.H. Yeow. Customizable Pneumatic Bending Actuator for Finger Rehabilitation. Design of Medical Devices Conference Europe 2014 (Delft)
- BackgroundC.H. Yeow, A.T. Baisch, S.G. Talbot, C.J. Walsh. Differential spring stiffness design for finger therapy exercise device: bio-inspired from stiff pathological finger joints. ASME Journal of Medical Devices 2012
- Background: PubMed 22479236Ang KK, Chin ZY, Wang C, Guan C, Zhang H. Filter Bank Common Spatial Pattern Algorithm on BCI Competition IV Datasets 2a and 2b. Front Neurosci. 2012 Mar 29;6:39. doi: 10.3389/fnins.2012.00039. eCollection 2012.
- Background: PubMed 25721551Ang KK, Guan C, Phua KS, Wang C, Zhao L, Teo WP, Chen C, Ng YS, Chew E. Facilitating effects of transcranial direct current stimulation on motor imagery brain-computer interface with robotic feedback for stroke rehabilitation. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S79-87. doi: 10.1016/j.apmr.2014.08.008.
- Background: PubMed 24756025Ang KK, Chua KS, Phua KS, Wang C, Chin ZY, Kuah CW, Low W, Guan C. A Randomized Controlled Trial of EEG-Based Motor Imagery Brain-Computer Interface Robotic Rehabilitation for Stroke. Clin EEG Neurosci. 2015 Oct;46(4):310-20. doi: 10.1177/1550059414522229. Epub 2014 Apr 21.
- Background: PubMed 25120465Ang KK, Guan C, Phua KS, Wang C, Zhou L, Tang KY, Ephraim Joseph GJ, Kuah CW, Chua KS. Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke. Front Neuroeng. 2014 Jul 29;7:30. doi: 10.3389/fneng.2014.00030. eCollection 2014.
- Background: PubMed 17662011Rojas JI, Zurru MC, Romano M, Patrucco L, Cristiano E. Acute ischemic stroke and transient ischemic attack in the very old--risk factor profile and stroke subtype between patients older than 80 years and patients aged less than 80 years. Eur J Neurol. 2007 Aug;14(8):895-9. doi: 10.1111/j.1468-1331.2007.01841.x.
- Background: PubMed 18086926Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.
- Individual participant dataSharing planned: No
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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.
Jeong Hoon Lim principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI Robot Assisted Hand Therapy and CPM Robot Assisted 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 10 inclusion and 6 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 30 Apr 2019. 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?
Action Research Arm Test (time frame: 30 minutes). 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 NCT03277508, which also lists 15 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 30 Apr 2019.