StrokeNCT00955838
Brain Computer Interface (BCI) Based Robotic Rehabilitation for Stroke
A study testing Rehabilitation technique in people with Stroke, run by National Neuroscience Institute at 1 site in Singapore.
Trial summary
The trial aims to test a novel rehabilitation device for subacute stroke hemiplegic upper limbs based on state-of-the-art non invasive Brain-Computer Interface (BCI) robotic rehabilitation in a clinical setting. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Rehabilitation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2007to Oct 2009
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Demographics: 21 to 65 years, within 12 months of first, single clinical stroke (ischaemic or haemorrhagic).
- Moderate to severe upper extremity (UE) weakness post stroke.
- Fugly-Meyer motor score of the upper limb < 40.
- Upper limb motor power MRC grade 3 or less /5 in at least 1 arm region.
- Able to give own consent and understand simple instructions and learn through practice.
- Resting brain states determined by FMRI criteria
Who cannot join
- Recurrent stroke.
- Previous brain surgery.
- Spasticity of Modified Ashworth scale > 2.
- Fixed contracture of any upper limb joint
- Ataxia, dystonia or tremor of the involved upper limb or previous cervical myelopathy
- Upper limb pain or painful joints in upper limb.
Show all 9Show fewer
- Severe cognitive impairment (Abbreviated Mental Test <7/10), or severe aphasia which may affect ability to participate in training.
- . History of seizures in the past 12 months.
- Severe left neglect
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Neuroscience Institute
Singapore, 308433
Beng Ti, Christopher Ang, MD, +65 63577191, beng_ti_ang@nni.com.sg
Beng Ti, Christopher Ang, MD
About this study
The trial aims to test a novel rehabilitation device for subacute stroke hemiplegic upper limbs based on state-of-the-art non invasive Brain-Computer Interface (BCI) robotic rehabilitation in a clinical setting. The investigators aim to prove the clinical efficacy and safety of BCI therapy over traditional rehabilitation methods.
Read the detailed description
The proposed rehabilitation device is the first neuro-rehabilitation system which combines non-invasive BCI and robotic rehabilitation for the paralysed stroke upper extremity within 6 months of stroke.Spontaneous recovery after stroke takes place over the first 6-12 months after stroke. The first 3-6 months are the most crucial periods as this is the period of maximal neurological recovery and neuroplasticity. Differential rates of recovery occur for various types of impairments post-stroke. In general, motor functions (mobility, walking, upper limb function, activities of daily living (ADL)) recover faster than cognitive or language impairments which may recover over 12 months. A number of approaches to stroke injury rehabilitation have been introduced to facilitate intrinsic recovery or aid adaptive compensation for stroke-related impairments. Generally for rehabilitative training to be effective, it must be commenced as early as possible after stroke. Current research proves that rehabilitation using traditional neuro-facilitation approaches is effective in improving neurological and functional recovery and is superior to no treatment or nursing care alone. Rehabilitated patients have shorter total hospitalization stays, lower complication rates, earlier and higher rates of discharge home than patients who do not receive rehabilitation. In addition, rehabilitation involving a multidisciplinary team approach led by rehabilitation physician or specialist result in better functional outcomes compared to acute general ward-based therapies. In order for rehabilitation to be effective in modifying cortical neuroplasticity, it must be targeted at the specific stroke impairment, task specific, exercise must be repetitive and intensive, goal directed and command the attention of the stroke patient. Some of the components of rehabilitation include physical therapy, gait and balance training, aerobic conditioning, functional Activities of Daily Living (ADL) training, physical modalities to treat pain, Functional Electrical Stimulation (FES) or Neuro-Muscular Electrical Stimulation (NMES). Other methods include specific treatments to address complications of rehabilitation such as spasticity, ataxia, contractures and bladder or bowel incontinence. Often, one-to-one and highly labour-intensive and expensive therapies with close hand-over-hand treatments are required. Limitations of current physiotherapy and occupational therapy techniques include the following:(1) Difficulties in rehabilitation for the severely paralysed arm and hand which are often treated with passive modalities such as NMES, passive ROMs and other modalities. (2) Difficulties in achieving intensive rehabilitation and high repetitions in those with moderate to severe upper extremity paralysis either due to non participation or pain which is commoner in those with severe paralysis. (3)Problems in motivating and sustaining patient interest in repetitive exercises.(4)Therapy is often perceived to be boring and due to lack of immediate biofeedback. (I) Robot Aided Rehabilitation: MIT (USA) has developed a robot, named the MIT-MANUS, to aid therapy of stroke victims. Small clinical trials have reported that the robot significantly improved patients' recovery of arm motor movement and function with sustained gains several months after cessation of treatment. This system is being clinically used as a rehabilitation training tool in over 20 centres world-wide. Advantages of robot aided rehabilitation include the ability to document and store motion and force parameters, the ability to achieve thousands of repetitions per treatment session (100 times more than conventional treatment or FES) without causing tissue injury or pain, high intensity with low friction, attention training and increased biofeedback through the incorporation of interactive video games, which can simulate trajectories, mazes, ADL tasks such as preparing a meal and spatial task simulation such as going shopping. In addition, after the initial training period, supervision of the patient by the therapist can be reduced due to the sustainability of participation of the patient from the robot or BCI based Robotic Rehabilitation. Hence, productivity of the human therapist is increased by the robot. The robot thus acts as a high technology aid to the clinician and therapist. The system is also portable, giving rise to the possibility of tele-rehabilitation options with the performance and progress of the patient being monitored by the institution remotely. (II)BCI-based BCI based Robotic Rehabilitation:This non invasive device aims to use a novel approach in robotic training, which has not been employed in the therapeutic realm before.In the MIT-MANUS and related commercially available systems, there is no direct communication between the patient's mind or thinking processes or motor volitional thinking and the robotic system. Although some sensors are used to detect the patient's weak movement, it never knows when and how the patient wants to move. The robot arm to which the patient is tethered or constrained plans the trajectory of movement for the patient and reduces its active role as the patient recovers voluntary motion. In most times, the patient can only passively follow the predefined program, which may not fully explore the patient's motor initiatives and potential or attention processes.
- Conditions
- Stroke
- Being tested
- Rehabilitation technique
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation techniqueOther
Also called Stroke Rehabilitation technique
12 therapy session
| Study group | Role | What they receive |
|---|---|---|
| Manus | Experimental | Not described Receives: Other: Rehabilitation technique |
| BCI_Manus | Experimental | Not described Receives: Other: Rehabilitation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motricity score for hemiplegic upper limb (shoulder abduction, elbow flexion, finger-thumb opposition
Measured: Baseline (0 months), 4, 12 and 24 weeks
Fugly Meyer motor score for upper limb (0-66)
Measured: Baseline (0 months), 4, 12 and 24 weeks
Motor Assessment Scale
Measured: Baseline (0 months), 4, 12 and 24 weeks
Secondary outcomes (2)
Functional assessments
Measured: Baseline (0 months), 4, 12 and 24 weeks
Neuroradiological parameters
Measured: Baseline (0 months), 4, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startApr 2007
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Neuroscience Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Institue for Infocomm Research, A*Star
- Investigators
- Beng Ti, Christopher Ang, MD, Principal investigator, National Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955838
- Sponsor's protocol ID
- BCIStroke
- Status last verified
- Aug 2009
- First submitted
- 6 Aug 2009
- Last updated
- 10 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Computer Interface (BCI) Based Robotic Rehabilitation for Stroke
- ClinicalTrials.gov ID
- NCT00955838
- Acronym / sponsor ID
- BCIStroke
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Neuroscience InstituteUniversity, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Institue for Infocomm Research, A*Star
- Study start
- Apr 2007
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 10 Aug 2009 (estimated)
- 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.
The trial aims to test a novel rehabilitation device for subacute stroke hemiplegic upper limbs based on state-of-the-art non invasive Brain-Computer Interface (BCI) robotic rehabilitation in a clinical setting. The investigators aim to prove the clinical efficacy and safety of BCI therapy over traditional rehabilitation methods.
Detailed description
The proposed rehabilitation device is the first neuro-rehabilitation system which combines non-invasive BCI and robotic rehabilitation for the paralysed stroke upper extremity within 6 months of stroke.Spontaneous recovery after stroke takes place over the first 6-12 months after stroke. The first 3-6 months are the most crucial periods as this is the period of maximal neurological recovery and neuroplasticity. Differential rates of recovery occur for various types of impairments post-stroke. In general, motor functions (mobility, walking, upper limb function, activities of daily living (ADL)) recover faster than cognitive or language impairments which may recover over 12 months. A number of approaches to stroke injury rehabilitation have been introduced to facilitate intrinsic recovery or aid adaptive compensation for stroke-related impairments. Generally for rehabilitative training to be effective, it must be commenced as early as possible after stroke. Current research proves that rehabilitation using traditional neuro-facilitation approaches is effective in improving neurological and functional recovery and is superior to no treatment or nursing care alone. Rehabilitated patients have shorter total hospitalization stays, lower complication rates, earlier and higher rates of discharge home than patients who do not receive rehabilitation. In addition, rehabilitation involving a multidisciplinary team approach led by rehabilitation physician or specialist result in better functional outcomes compared to acute general ward-based therapies. In order for rehabilitation to be effective in modifying cortical neuroplasticity, it must be targeted at the specific stroke impairment, task specific, exercise must be repetitive and intensive, goal directed and command the attention of the stroke patient. Some of the components of rehabilitation include physical therapy, gait and balance training, aerobic conditioning, functional Activities of Daily Living (ADL) training, physical modalities to treat pain, Functional Electrical Stimulation (FES) or Neuro-Muscular Electrical Stimulation (NMES). Other methods include specific treatments to address complications of rehabilitation such as spasticity, ataxia, contractures and bladder or bowel incontinence. Often, one-to-one and highly labour-intensive and expensive therapies with close hand-over-hand treatments are required. Limitations of current physiotherapy and occupational therapy techniques include the following:(1) Difficulties in rehabilitation for the severely paralysed arm and hand which are often treated with passive modalities such as NMES, passive ROMs and other modalities. (2) Difficulties in achieving intensive rehabilitation and high repetitions in those with moderate to severe upper extremity paralysis either due to non participation or pain which is commoner in those with severe paralysis. (3)Problems in motivating and sustaining patient interest in repetitive exercises.(4)Therapy is often perceived to be boring and due to lack of immediate biofeedback. (I) Robot Aided Rehabilitation: MIT (USA) has developed a robot, named the MIT-MANUS, to aid therapy of stroke victims. Small clinical trials have reported that the robot significantly improved patients' recovery of arm motor movement and function with sustained gains several months after cessation of treatment. This system is being clinically used as a rehabilitation training tool in over 20 centres world-wide. Advantages of robot aided rehabilitation include the ability to document and store motion and force parameters, the ability to achieve thousands of repetitions per treatment session (100 times more than conventional treatment or FES) without causing tissue injury or pain, high intensity with low friction, attention training and increased biofeedback through the incorporation of interactive video games, which can simulate trajectories, mazes, ADL tasks such as preparing a meal and spatial task simulation such as going shopping. In addition, after the initial training period, supervision of the patient by the therapist can be reduced due to the sustainability of participation of the patient from the robot or BCI based Robotic Rehabilitation. Hence, productivity of the human therapist is increased by the robot. The robot thus acts as a high technology aid to the clinician and therapist. The system is also portable, giving rise to the possibility of tele-rehabilitation options with the performance and progress of the patient being monitored by the institution remotely. (II)BCI-based BCI based Robotic Rehabilitation:This non invasive device aims to use a novel approach in robotic training, which has not been employed in the therapeutic realm before.In the MIT-MANUS and related commercially available systems, there is no direct communication between the patient's mind or thinking processes or motor volitional thinking and the robotic system. Although some sensors are used to detect the patient's weak movement, it never knows when and how the patient wants to move. The robot arm to which the patient is tethered or constrained plans the trajectory of movement for the patient and reduces its active role as the patient recovers voluntary motion. In most times, the patient can only passively follow the predefined program, which may not fully explore the patient's motor initiatives and potential or attention processes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manus | Experimental | Other: Rehabilitation technique |
| BCI_Manus | Experimental | Other: Rehabilitation technique |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Demographics: 21 to 65 years, within 12 months of first, single clinical stroke (ischaemic or haemorrhagic).
- Moderate to severe upper extremity (UE) weakness post stroke.
- Fugly-Meyer motor score of the upper limb < 40.
- Upper limb motor power MRC grade 3 or less /5 in at least 1 arm region.
- Able to give own consent and understand simple instructions and learn through practice.
Key exclusion criteria (9 listed)
- Recurrent stroke.
- Previous brain surgery.
- Spasticity of Modified Ashworth scale > 2.
- Fixed contracture of any upper limb joint
- Ataxia, dystonia or tremor of the involved upper limb or previous cervical myelopathy
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 |
|---|---|---|
| Rehabilitation techniqueAlso: Stroke Rehabilitation technique12 therapy session | Other | BCI_Manus, Manus |
Primary outcome
Motricity score for hemiplegic upper limb (shoulder abduction, elbow flexion, finger-thumb opposition
Time frame: Baseline (0 months), 4, 12 and 24 weeks
Fugly Meyer motor score for upper limb (0-66)
Time frame: Baseline (0 months), 4, 12 and 24 weeks
Motor Assessment Scale
Time frame: Baseline (0 months), 4, 12 and 24 weeks
2 secondary outcomes
Functional assessments
Time frame: Baseline (0 months), 4, 12 and 24 weeks
Neuroradiological parameters
Time frame: Baseline (0 months), 4, 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2009.
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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.
Beng Ti, Christopher Ang, MD principal investigator
National Neuroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation technique in people with Stroke, run by National Neuroscience Institute 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Aug 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sui Geok, Karen Chua, MD (+(65)64506164, Karen_Chua@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motricity score for hemiplegic upper limb (shoulder abduction, elbow flexion, finger-thumb opposition (time frame: Baseline (0 months), 4, 12 and 24 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?
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 10 Aug 2009.