Clinical trial NCT05322837: Tracking of Upper Limb Sensory and Motor Recovery in Asian Stroke Survivors
Official title: Deep Phenotyping of Upper Limb Sensori-motor Recovery in Asian Stroke Survivors: Concept, Development and Implementation of a Rehabilomics-driven Technology-assisted Data Platform
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Rehabilitation Research Institute of Singapore (RRIS)
name: Singapore-ETH Centre (SEC)
First posted: 2022-04-12
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to inpatient rehabilitation unit

Brief summary: As Singapore's population is aging rapidly, the incidence rate of stroke has been increasing in the past years. Rehabilitation is essential for the resumption of daily activities, and with the appropriate care, it is possible for stroke-survivors to regain most of their functions.

Hence, this study aims to better understand upper limb recovery covering different stages post-stroke in a representative cohort of Asian adults

Detailed description: Stroke is a leading contributor to disability in Singapore, partially driven by a reduced ability to use the upper limb in their daily lives. Reduced upper limb use commonly results from a variety of impairments such as motor, sensory and cognitive impairments.

The aim of this longitudinal and observational study is to gather a rich multi-modal database on the time-course of upper limb recovery in a representative cohort after stroke and characterise the relationship between upper limb recovery, common post-stroke impairments and quality of life.

Eligibility criteria: Inclusion Criteria:

1. Stroke confirmed by neurologists, neurosurgeons and brain imaging (CT, CT angiogram, MRI, MR angiogram)
2. First ever confirmed stroke
3. Asian ethnicity
4. Age 21-90 years
5. Montreal Cognitive Assessment (MOCA) scores 21/30 and above
6. Admission to rehabilitation ward is within 8 weeks of stroke onset

Exclusion Criteria:

1. Recurrent stroke or transient ischaemic attack (TIA)
2. Upper limb impairment not related to stroke: e.g., subarachnoid haemorrhage, traumatic brain injury or brain tumours
3. Bilateral upper limb impairment.
4. Uncontrolled medical conditions such as hypertension, hypotension, diabetes mellitus, unstable angina, cardiac failure or sepsis will be excluded.
5. Active fractures or arthritis of upper limb joints/bones
6. Visual Analogue Scale (VAS) pain \> 5/10
7. MOCA \< 21/30
8. Severe behavioural disturbance or agitation or epilepsy or untreated depression
9. Life expectancy \< 6 months
10. End organ failures on replacements (renal dialysis or renal replacement therapies)
11. Minimally responsive or unresponsive awareness (vegetative) states
12. Pregnancy or lactation states
13. Admission to rehab ward later than 8 weeks post-stroke
14. (For TMS assessments only) History of epilepsy or seizures, or cranial surgeries, or have metal implants in body or head, or have implanted electronics, or have metallic valve, or skull fracture or brain injury, or head or brain surgeries.

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Inpatient: week 1 of admission
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Dr Karen Chua, MBBS
role: PRINCIPAL_INVESTIGATOR
References: