Longitudinal Multimodal Profiling of Balance and Gait In Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06187467
• Other study ID #: DSRB 2023/00805
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: Tan Tock Seng Hospital
• Contact: Ummi Artika
• Phone: 68894580
• Email: ummi_artika_marwi[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Clinical and technological-aided assessments and questionnaires
Assessments and questionnaires to quantify cortical and motor activities using portable EEG and lower limb sensors during dynamic balance and gait activities.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Nanyang Technological University

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	Berg Balance Scale	To assess functional balance	Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)
Secondary	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)
Secondary	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)
Secondary	6-minute Walk Test	Determine the functional exercise capacity	Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)