Longitudinal Multimodal Profiling of Balance and Gait In Stroke

NCT06187467 | Recruiting

• 1 other identifier: DSRB 2023/00805
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Electroencephalographic (EEG); Brain Computer Interfaces

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Fugl Meyer Assessment for Lower Limbs

  Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

• Berg Balance Scale

  Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

• Modified Clinical Test for Sensory Interaction in Balance

  Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

• 10-metre Walk Test

  Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

• 6-minute Walk Test

  Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

Interventions

Clinical and technological-aided assessments and questionnaires OTHER

Assessments and questionnaires to quantify cortical and motor activities using portable EEG and lower limb sensors during dynamic balance and gait activities.

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in outpatient clinics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Nanyang Technological University: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Dr Wee Seng Kwee

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

• Dr Karen Chua

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Low Ai Mei Jaclyn

CONTACT

68894580; Jaclyn_AM_LOW@ttsh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 2, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)