Longitudinal Multimodal Profiling of Balance and Gait In Stroke

Longitudinal Multimodal Profiling of Balance and Gait In Stroke Using EEG and Lower Limb Sensors: A Feasibility Study.

Balance and gait recovery is a critical aspect of post-stroke motor rehabilitation. Researchers have effectively utilized EEG to investigate different aspects of lower limb motor control, however there are several technical challenges in the existing brain computer interface (BCI) motor profiling.

The study aims to test the EEG-BCI system to see if it's effective in understanding the balance and walking patterns of post-stroke populations.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Clinical and technological-aided assessments and questionnaires

Detailed Description

Brain Computer Interface represent a groundbreaking field at the crossroads of neuroscience and engineering, serving as a direct communication link between the human brain and computer system.

Despite advancements in BCI technology, the electrocortical oscillations during human walking remain relatively unexplored, providing an opportunity for pioneering investigations.

The research highlights the feasibility of using EEG to decode neural patterns associated with various functions and aims to contribute to existing knowledge by using advanced EEG-based techniques to predict balance and gait patterns with the ultimate goal of tailoring rehabilitation approaches to individual patient needs.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Low Ai Mei Jaclyn; Phone Number: 68894580; Email: Jaclyn_AM_LOW@ttsh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Tan Tock Seng Hospital
    • Contact: Low Jaclyn; Email: Jaclyn_AM_LOW@ttsh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in outpatient clinics

Description

Inclusion Criteria:

• First-ever clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors brain imaging
• Age 21 to 85 years
• At least ≥ 30 days post-stroke
• Gait impairments related to stroke
• Functional ambulation category -6 levels (Mehrholz et al, 2007): FAC ≥ 4, i.e. able to ambulate independently on level surface but requires supervision to negotiate (e.g. stairs, inclines, non-level surfaces).
• Montreal Cognitive Assessment (MoCA) score > 21 (Nasreddine et al., 2005)
• Able to understand study instructions and requirements

Exclusion Criteria:

• Non-stroke related causes of gait impairment
• Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, dialysis, unresolved cancers e.g.,), active seizures within 3 months
• Anticipated life expectancy of < 6 months
• On subcutaneous or oral anti-coagulation
• Local factors potentially worsened by gait training: joint and muscle pains
• Lower limb pain VAS >4/10, active lower limb fractures or arthritis, fixed leg contractures, severe peripheral vascular disease, organomegaly or aortic aneurysms
• Active unhealed skin wounds or inflammatory skin conditions over trunk and lower limbs,
• Severe visual impairment or visual neglect affecting navigation
• Known allergy to EEG gel (Recoverix)
• Presence of craniectomy skull defect
• Resident of nursing home or overseas country which may compromise attendance at research site
• Pregnant or lactating females

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG Activities	To record EEG and EOG data from 64-Ch ActiCap EEG cap and electrode	Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Goniometers	7 sensors to measure 2-axis joint angles at bilateral Hip, Knee and Ankle	Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Assessment for Lower Limbs	Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function	Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Berg Balance Scale	To assess functional balance	Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Modified Clinical Test for Sensory Interaction in Balance	Assess complex sensory system to assist in determining which sensory system the individual relies upon (visual, somatosensory, vestibul)	Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
10-metre Walk Test	To assess walking speed over a short distance	Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
6-minute Walk Test	Determine the functional exercise capacity	Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: Nanyang Technological University
• Investigators: Principal Investigator: Dr Wee Seng Kwee, Tan Tock Seng Hospital; Principal Investigator: Dr Karen Chua, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Electroencephalographic (EEG); Brain Computer Interfaces
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: DSRB 2023/00805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No