StrokeNCT07784920
Lifescapes System in Post-stroke Hand Recovery
A study testing Lifescapes in people with Stroke, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial summary
Stroke is a leading cause of long-term disability, with 30-60% of survivors remaining unable to use their affected arms after discharge. Existing rehabilitation approaches such as motor imagery, robotic assistance, and neuromodulation have shown limited effectiveness for hand motor recovery. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Lifescapes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Oct 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-80 years old;
- First-ever or recurrent ischemic or haemorrhagic stroke;
- Stroke onset between 8 weeks and 5 years prior to enrolment;
- Moderate to severe unilateral upper-limb motor impairment following stroke, defined as a baseline upper-extremity Fugal-Meyer Assessment (FMA-UE) score <47, and Manual Muscle Testing (MMT) of finger extensor ≤2;
- Being able to provide informed consent, understand and follow verbal instructions.
- Having sufficient visual acuity to scan full computer screen.
Who cannot join
- Pregnant or breastfeeding women;
- Bilateral stroke;
- Modified Ashworth Scale (MAS) of finger flexors >2;
- Use of a pacemaker or of other implanted stimulators;
- History of seizures within 90 days before enrolment;
- Impossible to record EEG because of skin status or skull deformity;
- Sensorimotor disturbance due to other causes other than stroke;
- Medically unstable or uncontrolled conditions that may compromise safety or the ability to complete scheduled visits.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites
Alexandra Hospital
Singapore
Peiing Su, 65 64722000, peijing_su@nuhs.edu.sg
Ning Tang, ning_tang@nuhs.edu.sg
National University Hospital
Singapore
Peijing Su, 65 69082222, peijing_su@nuhs.edu.sg
Ning Tang, ning_tang@nuhs.edu.sg
About this study
Official title: Effectiveness and Feasibility of a Brain-computer Interface Based Neurofeedback System With Reduced Therapist Supervision for Hand Motor Recovery in Stroke Patients
Stroke is a leading cause of long-term disability, with 30-60% of survivors remaining unable to use their affected arms after discharge. Existing rehabilitation approaches such as motor imagery, robotic assistance, and neuromodulation have shown limited effectiveness for hand motor recovery. The Lifescapes system is a novel EEG-based brain-computer interface that combines motor imagery practice, biofeedback, neuromuscular electrical stimulation, and robotic assistance to help post-stroke patients with severe hand paralysis. A recent clinical trial in 40 patients demonstrated promising improvements in motor function with the Lifescapes system, supporting its potential as a rehabilitation tool.
This study aims to evaluate whether Lifescapes therapy delivered with reduced therapist supervision can improve upper-limb motor function in stroke patients, and whether such an approach is operationally feasible in the local clinical setting.
Read more
32 participants will be recruited from Alexandra Hospital and National University Hospital over 2 years.
Participants must be aged 21-80, have had a stroke between 8 weeks and 5 years before enrolment, and have moderate to severe upper-limb impairment. They must be able to give informed consent and follow instructions. Participants are excluded if they are pregnant, have bilateral stroke, severe finger spasticity (MAS >2), implanted stimulators or pacemakers, recent seizures within 90 days, or any unstable medical conditions.
Participants will complete 16 sessions of Lifescapes BCI training over 4-8 weeks (2-4 sessions per week, approximately 30 minutes each). Therapist assistance will be progressively reduced based on each participant's ability, though a therapist remains present throughout. Each Lifescapes session is followed by a 30-minute GRASP session, a standardised self-directed arm and hand exercise programme prescribed by an occupational therapist.
Participants will attend up to 21 visits over 5-6 months. Outcomes are assessed at 6 timepoints: pre-baseline (2-4 weeks before starting), baseline, after the 8th session, after the 16th session, and at 1-month and 3-month follow-up (the latter optional). Outcome measures include the Fugl-Meyer Assessment for the upper extremity (FMA-UE), Action Research Arm Test (ARAT), grip and pinch strength, Modified Ashworth Scale (MAS), Motor Activity Log-14 (MAL-14), EQ-5D-5L quality of life measure, and optional TMS measurement of corticospinal excitability.
Read the detailed description
Background
Stroke is a leading cause of adult long-term disability, with 30-60% of stroke survivors remaining unable to use their affected arms after discharge. While many interventional approaches have been tested - including motor imagery, robotic movement assistance, and neuromodulation - therapeutic efficacy remains limited for hand motor function. The Lifescapes system is a novel EEG-based brain-computer interface (BCI) neurofeedback system that facilitates motor imagery practice in post-stroke patients with severe hemiparesis, integrating biofeedback, neuromuscular electrical stimulation (NMES), and robot-aided sensorimotor stimulation. By triggering NMES and robotic assistance contingent on sensorimotor rhythm event-related desynchronisation (SMR-ERD) magnitude, the system enables voluntary modulation of endogenous sensorimotor activities in the ipsilesional hemisphere. A recent RCT in 40 chronic post-stroke hemiplegic patients demonstrated a significant between-group difference in Fugl-Meyer Assessment scores in favour of the Lifescapes group, supporting its potential as an adjunctive rehabilitation approach.
Study Objectives
The primary objective is to evaluate the effectiveness of Lifescapes therapy with reduced therapist supervision in improving upper-limb motor function in sub-acute and chronic stroke patients with moderate to severe upper limb paresis. The secondary objective is to evaluate the operational feasibility of Lifescapes with reduced therapist supervision in the local context. It is hypothesised that Lifescapes therapy with reduced therapist supervision is feasible in this study population and will quantitatively improve hand motor function.
Study Design
This is a single-arm, prospective study to evaluate the real-world effectiveness and feasibility of Lifescapes with reduced therapist supervision for post-stroke upper-limb rehabilitation. 32 subjects will be recruited from Alexandra Hospital (AH) and National University Hospital (NUH) over an estimated study duration of 2 years.
Participants
Inclusion criteria are: age 21-80 years; first-ever or recurrent ischemic or haemorrhagic stroke; stroke onset between 8 weeks and 5 years prior to enrolment; moderate to severe unilateral upper-limb motor impairment defined as a baseline FMA-UE score <47 and Manual Muscle Testing (MMT) of finger extensor ≤2; ability to provide informed consent and follow verbal instructions; and sufficient visual acuity to scan a full computer screen.
Exclusion criteria include: pregnant or breastfeeding women; bilateral stroke; Modified Ashworth Scale (MAS) of finger flexors >2; use of a pacemaker or other implanted stimulators; history of seizures within 90 days before enrolment; inability to record EEG due to skin status or skull deformity; sensorimotor disturbance due to causes other than stroke; and medically unstable or uncontrolled conditions that may compromise safety or the ability to complete scheduled visits.
Intervention
Eligible subjects will undergo 16 sessions of MI-BCI training with NMES and robotic movement assistance using the paralysed hand through the Lifescapes device. The intervention course must be completed within 4-8 weeks from the first to the last session, at a target frequency of 2-4 sessions per week. Therapist assistance during each Lifescapes session will be reduced progressively according to individual ability, though a therapist will remain present throughout in case assistance is needed. Each session is approximately 30 minutes.
Following each Lifescapes session, participants will complete a standardised occupational therapy programme - GRASP (Graded Repetitive Arm Supplementary Program) - supervised by a trained research staff member. All occupational tasks will be selected from the GRASP task pool and prescribed by an occupational therapist. Each GRASP session will take approximately 30 minutes.
Study Visits and Assessments
There will be up to 21 study visits over 5-6 months, comprising 16 intervention sessions and 6 rounds of assessment at the following timepoints: 2-4 weeks before the first Lifescapes session (pre-baseline), before the first session (baseline), after the 8th session (interim), after the 16th session (post), 1 month after the 16th session (1-month follow-up), and 3 months after the 16th session (3-month follow-up, optional).
Outcome Measures
Clinical outcomes assessed at each timepoint include: Upper Extremity Fugl-Meyer Assessment (FMA-UE); Action Research Arm Test (ARAT); grip and pinch strength measured by dynamometer; Modified Ashworth Scale (MAS) of the affected upper limb muscles; Motor Activity Log-14 (MAL-14); EQ-5D-5L; and corticospinal excitability measurement by TMS (optional).
- Conditions
- Stroke
- Being tested
- Lifescapes
- Keywords
- Stroke, Rehabilitation, hand motor recovery, brain-computer interface
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifescapesDevice
Lifescapes device is an EEG-based brain-computer-interface (BCI) neurofeedback system. It was developed to facilitate motor imagery (MI) practice in post-stroke patients with severe hemiparesis who are unable to perform voluntary finger extension, serving as a substitute for actual movement exercise. The system comprises 4 components: standard medical treatments with motor imagery (3), biofeedback (4), neuromuscular electrical stimulation (NMES) to paretic muscles (5), and robot-aided sensorimotor stimulation (6). By integrating these components, the EEG-based BCI system enables voluntary modulation of endogenous sensorimotor activities in the ipsilesional hemisphere by triggering the NMES and robotic device contingent on the sensorimotor rhythm event-related desynchronization (SMR-ERD) magnitude.
| Study group | Role | What they receive |
|---|---|---|
| MI-BCI training with NMES and robotic movement assistance | Experimental | Eligible subjects will undergo 16 sessions of MI-BCI training with NMES and robotic movement assistance using the paralyzed hand through the Lifescapes device. Receives: Device: Lifescapes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Measured: Week 0 (Pre-baseline assessment)
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Measured: Week 2 (baseline assessment)
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Measured: Week 5 (Interim-intervention assessment)
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Measured: Week 8 (Post-intervention assessment)
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Measured: Week12 (1 month after the intervention)
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Measured: Week 20 (3 months after the intervention)
Secondary outcomes (32)
Action Research Arm Test (ARAT)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Measured: Week 0 (Pre-baseline assessment)
Action Research Arm Test (ARAT)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Measured: Week 2 (baseline assessment)
Action Research Arm Test (ARAT)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Measured: Week 5 (Interim-intervention assessment)
Action Research Arm Test (ARAT)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Measured: Week 8 (Post-intervention assessment)
Action Research Arm Test (ARAT)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Measured: Week12 (1 month after the intervention)
Action Research Arm Test (ARAT)
It evaluates UL motor function and status in standardized format using 19 tests of upper limb motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke. The ARAT has a maximum score of 57, with scores ranging from 0 to 57, where higher scores indicate better upper limb function.
Measured: Week 20 (3 months after the intervention)
Grip and pinch strength
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Measured: Week 0 (Pre-baseline assessment)
Grip and pinch strength
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Measured: Week 2 (baseline assessment)
Grip and pinch strength
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Measured: Week 5 (Interim-intervention assessment)
Grip and pinch strength
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Measured: Week 8 (Post-intervention assessment)
Grip and pinch strength
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Measured: Week12 (1 month after the intervention)
Grip and pinch strength
Grip and pinch strength will be measured using a hand dynamometer. Grip strength is assessed by asking the participant to squeeze the dynamometer as hard as possible, while pinch strength measures the force exerted between the thumb and fingers. Results are recorded in kilograms or pounds of force. These measures provide an objective assessment of hand and forearm muscle strength, and will be used to track changes in upper limb strength over the course of the study.
Measured: Week 20 (3 months after the intervention)
Modified Ashworth Scale (MAS)
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for upper limb muslces. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.
Measured: Week 0 (Pre-baseline assessment)
Modified Ashworth Scale (MAS)
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for upper limb muslces. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.
Measured: Week 2 (baseline assessment)
Modified Ashworth Scale (MAS)
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for upper limb muslces. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.
Measured: Week 5 (Interim-intervention assessment)
Modified Ashworth Scale (MAS)
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for upper limb muslces. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.
Measured: Week 8 (Post-intervention assessment)
Motor Activity Log-14 (MAL-14)
The Motor Activity Log-14 (MAL-14) consists of 14 items rated on two subscales - the Amount of Use (AOU) and Quality of Movement (QOM) scales. Each item is rated from 0 to 5, giving a total score range of 0 to 5 for each subscale, where higher scores indicate greater amount of use and better quality of movement of the affected arm in daily activities.
Measured: Week 12 (1 month after the intervention)
Motor Activity Log-14 (MAL-14)
The Motor Activity Log-14 (MAL-14) consists of 14 items rated on two subscales - the Amount of Use (AOU) and Quality of Movement (QOM) scales. Each item is rated from 0 to 5, giving a total score range of 0 to 5 for each subscale, where higher scores indicate greater amount of use and better quality of movement of the affected arm in daily activities.
Measured: Week 20 (3 months after the intervention)
EQ5D
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Measured: Week 0 (Pre-baseline assessment)
EQ5D
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Measured: Week 2 (baseline assessment)
EQ5D
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Measured: Week 5 (Interim-intervention assessment)
EQ5D
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Measured: Week 8 (Post-intervention assessment)
EQ5D
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Measured: Week12 (1 month after the intervention)
EQ5D
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Measured: Week 20 (3 months after the intervention)
Corticospinal Excitability measurement by TMS- Motor threshold
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Measured: Week 0 (Pre-baseline assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Measured: Week 2 (baseline assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Measured: Week 5 (Interim-intervention assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Measured: Week 8 (Post-intervention assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Measured: Week12 (1 month after the intervention)
Corticospinal Excitability measurement by TMS- Motor threshold
It is a non-invasive technique used to assess how readily the brain can activate the muscles. A magnetic coil is placed over the scalp above the motor area of the brain, and a brief magnetic pulse is delivered to stimulate the nerve pathways that connect the brain to the muscles (the corticospinal tract). The smallest pulse intensity needed to produce a visible or measurable muscle twitch is called the "motor threshold." A lower motor threshold means the brain-to-muscle pathway is more excitable or responsive, which is generally associated with better motor function.
Measured: Week 20 (3 months after the intervention)
System Usability Scale (SUS)
SUS is a validated, 10-item questionnaire. Each item is rated on a 5-point Likert scale ranging from strongly disagree to strongly agree.
Measured: Week 8 (Post-intervention assessment)
MoCA
It is a screening tool to detect mild cognitive impairment. It assesses several aspects of cognitive function, including memory, attention, language, and orientation. Scores range from 0 to 30, with a score of 26 or above generally considered normal. A lower score may indicate the presence of cognitive difficulties.
Measured: Week 0 (Pre-baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (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
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm, prospective study
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandra Hospital
- Responsible party
- Sponsor
- Investigators
- Peijing Su, MBBS, Principal investigator, NUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784920
- Sponsor's protocol ID
- 2026-0446
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Feasibility of a Brain-computer Interface Based Neurofeedback System With Reduced Therapist Supervision for Hand Motor Recovery in Stroke Patients
- ClinicalTrials.gov ID
- NCT07784920
- Acronym / sponsor ID
- 2026-0446
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, hand motor recovery, brain-computer interface
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Alexandra Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Aug 2026 (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 is a leading cause of long-term disability, with 30-60% of survivors remaining unable to use their affected arms after discharge. Existing rehabilitation approaches such as motor imagery, robotic assistance, and neuromodulation have shown limited effectiveness for hand motor recovery. The Lifescapes system is a novel EEG-based brain-computer interface that combines motor imagery practice, biofeedback, neuromuscular electrical stimulation, and robotic assistance to help post-stroke patients with severe hand paralysis. A recent clinical trial in 40 patients demonstrated promising improvements in motor function with the Lifescapes system, supporting its potential as a rehabilitation tool.
This study aims to evaluate whether Lifescapes therapy delivered with reduced therapist supervision can improve upper-limb motor function in stroke patients, and whether such an approach is operationally feasible in the local clinical setting.
32 participants will be recruited from Alexandra Hospital and National University Hospital over 2 years.
Participants must be aged 21-80, have had a stroke between 8 weeks and 5 years before enrolment, and have moderate to severe upper-limb impairment. They must be able to give informed consent and follow instructions. Participants are excluded if they are pregnant, have bilateral stroke, severe finger spasticity (MAS >2), implanted stimulators or pacemakers, recent seizures within 90 days, or any unstable medical conditions.
Participants will complete 16 sessions of Lifescapes BCI training over 4-8 weeks (2-4 sessions per week, approximately 30 minutes each). Therapist assistance will be progressively reduced based on each participant's ability, though a therapist remains present throughout. Each Lifescapes session is followed by a 30-minute GRASP session, a standardised self-directed arm and hand exercise programme prescribed by an occupational therapist.
Participants will attend up to 21 visits over 5-6 months. Outcomes are assessed at 6 timepoints: pre-baseline (2-4 weeks before starting), baseline, after the 8th session, after the 16th session, and at 1-month and 3-month follow-up (the latter optional). Outcome measures include the Fugl-Meyer Assessment for the upper extremity (FMA-UE), Action Research Arm Test (ARAT), grip and pinch strength, Modified Ashworth Scale (MAS), Motor Activity Log-14 (MAL-14), EQ-5D-5L quality of life measure, and optional TMS measurement of corticospinal excitability.
Detailed description
Background
Stroke is a leading cause of adult long-term disability, with 30-60% of stroke survivors remaining unable to use their affected arms after discharge. While many interventional approaches have been tested - including motor imagery, robotic movement assistance, and neuromodulation - therapeutic efficacy remains limited for hand motor function. The Lifescapes system is a novel EEG-based brain-computer interface (BCI) neurofeedback system that facilitates motor imagery practice in post-stroke patients with severe hemiparesis, integrating biofeedback, neuromuscular electrical stimulation (NMES), and robot-aided sensorimotor stimulation. By triggering NMES and robotic assistance contingent on sensorimotor rhythm event-related desynchronisation (SMR-ERD) magnitude, the system enables voluntary modulation of endogenous sensorimotor activities in the ipsilesional hemisphere. A recent RCT in 40 chronic post-stroke hemiplegic patients demonstrated a significant between-group difference in Fugl-Meyer Assessment scores in favour of the Lifescapes group, supporting its potential as an adjunctive rehabilitation approach.
Study Objectives
The primary objective is to evaluate the effectiveness of Lifescapes therapy with reduced therapist supervision in improving upper-limb motor function in sub-acute and chronic stroke patients with moderate to severe upper limb paresis. The secondary objective is to evaluate the operational feasibility of Lifescapes with reduced therapist supervision in the local context. It is hypothesised that Lifescapes therapy with reduced therapist supervision is feasible in this study population and will quantitatively improve hand motor function.
Study Design
This is a single-arm, prospective study to evaluate the real-world effectiveness and feasibility of Lifescapes with reduced therapist supervision for post-stroke upper-limb rehabilitation. 32 subjects will be recruited from Alexandra Hospital (AH) and National University Hospital (NUH) over an estimated study duration of 2 years.
Participants
Inclusion criteria are: age 21-80 years; first-ever or recurrent ischemic or haemorrhagic stroke; stroke onset between 8 weeks and 5 years prior to enrolment; moderate to severe unilateral upper-limb motor impairment defined as a baseline FMA-UE score <47 and Manual Muscle Testing (MMT) of finger extensor ≤2; ability to provide informed consent and follow verbal instructions; and sufficient visual acuity to scan a full computer screen.
Exclusion criteria include: pregnant or breastfeeding women; bilateral stroke; Modified Ashworth Scale (MAS) of finger flexors >2; use of a pacemaker or other implanted stimulators; history of seizures within 90 days before enrolment; inability to record EEG due to skin status or skull deformity; sensorimotor disturbance due to causes other than stroke; and medically unstable or uncontrolled conditions that may compromise safety or the ability to complete scheduled visits.
Intervention
Eligible subjects will undergo 16 sessions of MI-BCI training with NMES and robotic movement assistance using the paralysed hand through the Lifescapes device. The intervention course must be completed within 4-8 weeks from the first to the last session, at a target frequency of 2-4 sessions per week. Therapist assistance during each Lifescapes session will be reduced progressively according to individual ability, though a therapist will remain present throughout in case assistance is needed. Each session is approximately 30 minutes.
Following each Lifescapes session, participants will complete a standardised occupational therapy programme - GRASP (Graded Repetitive Arm Supplementary Program) - supervised by a trained research staff member. All occupational tasks will be selected from the GRASP task pool and prescribed by an occupational therapist. Each GRASP session will take approximately 30 minutes.
Study Visits and Assessments
There will be up to 21 study visits over 5-6 months, comprising 16 intervention sessions and 6 rounds of assessment at the following timepoints: 2-4 weeks before the first Lifescapes session (pre-baseline), before the first session (baseline), after the 8th session (interim), after the 16th session (post), 1 month after the 16th session (1-month follow-up), and 3 months after the 16th session (3-month follow-up, optional).
Outcome Measures
Clinical outcomes assessed at each timepoint include: Upper Extremity Fugl-Meyer Assessment (FMA-UE); Action Research Arm Test (ARAT); grip and pinch strength measured by dynamometer; Modified Ashworth Scale (MAS) of the affected upper limb muscles; Motor Activity Log-14 (MAL-14); EQ-5D-5L; and corticospinal excitability measurement by TMS (optional).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm, prospective study
| Arm | Type | Receives |
|---|---|---|
| MI-BCI training with NMES and robotic movement assistance | Experimental | Device: LifescapesEligible subjects will undergo 16 sessions of MI-BCI training with NMES and robotic movement assistance using the paralyzed hand through the Lifescapes device. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 21-80 years old;
- First-ever or recurrent ischemic or haemorrhagic stroke;
- Stroke onset between 8 weeks and 5 years prior to enrolment;
- Moderate to severe unilateral upper-limb motor impairment following stroke, defined as a baseline upper-extremity Fugal-Meyer Assessment (FMA-UE) score <47, and Manual Muscle Testing (MMT) of finger extensor ≤2;
- Being able to provide informed consent, understand and follow verbal instructions.
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women;
- Bilateral stroke;
- Modified Ashworth Scale (MAS) of finger flexors >2;
- Use of a pacemaker or of other implanted stimulators;
- History of seizures within 90 days before enrolment;
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 |
|---|---|---|
| LifescapesLifescapes device is an EEG-based brain-computer-interface (BCI) neurofeedback system. It was developed to facilitate motor imagery (MI) practice in post-stroke patients with severe hemiparesis who are unable to perform voluntary finger extension, serving as a substitute for actual movement exercise. The system comprises 4 components: standard medical treatments with motor imagery (3), biofeedback (4), neuromuscular electrical stimulation (NMES) to paretic muscles (5), and robot-aided sensorimotor stimulation (6). By integrating these components, the EEG-based BCI system enables voluntary modulation of endogenous sensorimotor activities in the ipsilesional hemisphere by triggering the NMES and robotic device contingent on the sensorimotor rhythm event-related desynchronization (SMR-ERD) magnitude. | Device | MI-BCI training with NMES and robotic movement assistance |
Primary outcome
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Time frame: Week 0 (Pre-baseline assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Time frame: Week 2 (baseline assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Time frame: Week 5 (Interim-intervention assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Time frame: Week 8 (Post-intervention assessment)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Time frame: Week12 (1 month after the intervention)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE)
Time frame: Week 20 (3 months after the intervention)
FMA-UE is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treat. Scores range from 0 to 66, with higher scores indicating better motor function.
32 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: Week 0 (Pre-baseline assessment)
Action Research Arm Test (ARAT)
Time frame: Week 2 (baseline assessment)
Action Research Arm Test (ARAT)
Time frame: Week 5 (Interim-intervention assessment)
Action Research Arm Test (ARAT)
Time frame: Week 8 (Post-intervention assessment)
Action Research Arm Test (ARAT)
Time frame: Week12 (1 month after the intervention)
Action Research Arm Test (ARAT)
Time frame: Week 20 (3 months after the intervention)
Grip and pinch strength
Time frame: Week 0 (Pre-baseline assessment)
Grip and pinch strength
Time frame: Week 2 (baseline assessment)
Grip and pinch strength
Time frame: Week 5 (Interim-intervention assessment)
Grip and pinch strength
Time frame: Week 8 (Post-intervention assessment)
Grip and pinch strength
Time frame: Week12 (1 month after the intervention)
Grip and pinch strength
Time frame: Week 20 (3 months after the intervention)
Modified Ashworth Scale (MAS)
Time frame: Week 0 (Pre-baseline assessment)
Modified Ashworth Scale (MAS)
Time frame: Week 2 (baseline assessment)
Modified Ashworth Scale (MAS)
Time frame: Week 5 (Interim-intervention assessment)
Modified Ashworth Scale (MAS)
Time frame: Week 8 (Post-intervention assessment)
Motor Activity Log-14 (MAL-14)
Time frame: Week 12 (1 month after the intervention)
Motor Activity Log-14 (MAL-14)
Time frame: Week 20 (3 months after the intervention)
EQ5D
Time frame: Week 0 (Pre-baseline assessment)
EQ5D
Time frame: Week 2 (baseline assessment)
EQ5D
Time frame: Week 5 (Interim-intervention assessment)
EQ5D
Time frame: Week 8 (Post-intervention assessment)
EQ5D
Time frame: Week12 (1 month after the intervention)
EQ5D
Time frame: Week 20 (3 months after the intervention)
Corticospinal Excitability measurement by TMS- Motor threshold
Time frame: Week 0 (Pre-baseline assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
Time frame: Week 2 (baseline assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
Time frame: Week 5 (Interim-intervention assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
Time frame: Week 8 (Post-intervention assessment)
Corticospinal Excitability measurement by TMS- Motor threshold
Time frame: Week12 (1 month after the intervention)
Corticospinal Excitability measurement by TMS- Motor threshold
Time frame: Week 20 (3 months after the intervention)
System Usability Scale (SUS)
Time frame: Week 8 (Post-intervention assessment)
MoCA
Time frame: Week 0 (Pre-baseline assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- 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.
Peijing Su, MBBS principal investigator
NUH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifescapes in people with Stroke, run by National University Hospital, Singapore at 2 sites 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 8 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: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peijing Su, MBBS (65 69082222, peijing_su@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Fugal-MeyerFugl-Meyer Assessment (FMA-UE) (time frame: Week 0 (Pre-baseline assessment)). The study lists 6 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 25 Aug 2026.