Longitudinal Multimodal Profiling of Balance and Gait In Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-85
SponsorTan Tock Seng Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients in outpatient clinics
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical and technological-aided assessments and questionnaires
Other interventionAssessments and questionnaires to quantify cortical and motor activities using portable EEG and lower limb sensors during dynamic balance and gait activities.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
EEG Activities
To record EEG and EOG data from 64-Ch ActiCap EEG cap and electrode
Time frame
Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)2
Goniometers
7 sensors to measure 2-axis joint angles at bilateral Hip, Knee and Ankle
Time frame
Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)Secondary outcomes
1
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
Time frame
Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)2
Berg Balance Scale
To assess functional balance
Time frame
Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)3
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)
Time frame
Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)4
10-metre Walk Test
To assess walking speed over a short distance
Time frame
Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tan Tock Seng Hospital
Lead sponsor
Nanyang Technological University
Collaborator
Source ClinicalTrials.gov