Lifescapes System in Post-stroke Hand Recovery
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorNational University Hospital, Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Pregnant or breastfeeding women;
Bilateral stroke;
Modified Ashworth Scale (MAS) of finger flexors >2;
Use of a pacemaker or of other implanted stimulators;
Trial design
Design model
Single group
Treatments tested in this trial
Lifescapes
DeviceLifescapes 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: MI-BCI training with NMES and robotic movement assistanceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 0 (Pre-baseline assessment)2
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.
Time frame
Week 2 (baseline assessment)3
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.
Time frame
Week 5 (Interim-intervention assessment)4
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.
Time frame
Week 8 (Post-intervention assessment)Secondary outcomes
1
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.
Time frame
Week 0 (Pre-baseline assessment)2
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.
Time frame
Week 2 (baseline assessment)3
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.
Time frame
Week 5 (Interim-intervention assessment)4
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.
Time frame
Week 8 (Post-intervention assessment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National University Hospital, Singapore
Lead sponsor
Alexandra Hospital
Collaborator
Source ClinicalTrials.gov
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