Lifescapes System in Post-stroke Hand Recovery

NCT07784920 | Not Yet Recruiting

• 1 other identifier: 2026-0446
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Stroke

Keywords

Stroke; Rehabilitation; hand motor recovery; brain-computer interface

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Week 20 (3 months after the intervention)

Secondary Outcomes (32)

• Action Research Arm Test (ARAT)

  Week 0 (Pre-baseline assessment)

• Action Research Arm Test (ARAT)

  Week 2 (baseline assessment)

• Action Research Arm Test (ARAT)

  Week 5 (Interim-intervention assessment)

• Action Research Arm Test (ARAT)

  Week 8 (Post-intervention assessment)

• Action Research Arm Test (ARAT)

  Week12 (1 month after the intervention)

Study Arms (1)

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.

Device: Lifescapes

Interventions

Lifescapes DEVICE

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.

MI-BCI training with NMES and robotic movement assistance

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandra Hospital: collaborator
• National University Hospital, Singapore: lead

Study Sites (2)

Alexandra Hospital

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peijing Su, MBBS

  NUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peijing Su, MBBS

CONTACT

65 69082222; peijing_su@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-arm, prospective study

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)