Tracking of Upper Limb Sensory and Motor Recovery in Asian Stroke Survivors

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322837
• Other study ID #: DSRB 2021/00919
• Status: Recruiting
• Start date: April 26, 2023
• Est. completion date: February 2025

Study information

• Verified date: June 2023
• Source: Tan Tock Seng Hospital
• Contact: Wei Binh Chong
• Phone: 63578225
• Email: wei_binh_chong[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Clinical and technological-aided assessments and questionnaires
Assessments and questionnaires related to upper limb function and quality of life will be used

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Rehabilitation Research Institute of Singapore (RRIS), Singapore-ETH Centre (SEC)

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment (FMA)	The FMA-UE is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, in patients with post-stroke hemiplegia.	Inpatient: week 1 of admission