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

Deep Phenotyping of Upper Limb Sensori-motor Recovery in Asian Stroke Survivors: Concept, Development and Implementation of a Rehabilomics-driven Technology-assisted Data Platform

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

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Clinical and technological-aided assessments and questionnaires

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Megan Lau Si En; Phone Number: 68894580; Email: Megan_SE_Lau@ttsh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Tan Tock Seng Hospital
    • Contact: Wei Binh Chong; Phone Number: 63578225; Email: wei_binh_chong@ttsh.com.sg
    • Contact: Dr Karen Chua, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to inpatient rehabilitation unit

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention	Other: Clinical and technological-aided assessments and questionnaires; Assessments and questionnaires related to upper limb function and quality of life will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: Rehabilitation Research Institute of Singapore (RRIS); Singapore-ETH Centre (SEC)
• Investigators: Principal Investigator: Dr Karen Chua, MBBS, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: DSRB 2021/00919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No