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

NCT05322837 | Recruiting

• 1 other identifier: DSRB 2021/00919
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention

Other: Clinical and technological-aided assessments and questionnaires

Interventions

Clinical and technological-aided assessments and questionnaires OTHER

Assessments and questionnaires related to upper limb function and quality of life will be used

Intervention

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to inpatient rehabilitation unit

You may qualify if:

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

You may not qualify if:

• Recurrent stroke or transient ischaemic attack (TIA)
• Upper limb impairment not related to stroke: e.g., subarachnoid haemorrhage, traumatic brain injury or brain tumours
• Bilateral upper limb impairment.
• Uncontrolled medical conditions such as hypertension, hypotension, diabetes mellitus, unstable angina, cardiac failure or sepsis will be excluded.
• Active fractures or arthritis of upper limb joints/bones
• Visual Analogue Scale (VAS) pain \> 5/10
• MOCA \< 21/30
• Severe behavioural disturbance or agitation or epilepsy or untreated depression
• Life expectancy \< 6 months
• End organ failures on replacements (renal dialysis or renal replacement therapies)
• Minimally responsive or unresponsive awareness (vegetative) states
• Pregnancy or lactation states
• Admission to rehab ward later than 8 weeks post-stroke
• (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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Rehabilitation Research Institute of Singapore (RRIS): collaborator
• Singapore-ETH Centre (SEC): collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

Related Publications (1)

• Cheng HJ, Chin LF, Kanzler CM, Lehner R, Kuah CWK, Kager S, Josse E, Samkharadze T, Sidarta A, Gonzalez PC, Lie E, Zbytniewska-Megret M, Wee SK, Liang P, Gassert R, Chua K, Lambercy O, Wenderoth N. Upper limb sensorimotor recovery in Asian stroke survivors: a study protocol for the development and implementation of a Technology-Assisted dIgitaL biOmaRker (TAILOR) platform. Front Neurol. 2023 Nov 30;14:1246888. doi: 10.3389/fneur.2023.1246888. eCollection 2023.

  PMID: 38107648 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Dr Karen Chua, MBBS

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Lau Si En

CONTACT

68894580; Megan_SE_Lau@ttsh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 12, 2022
• Study Start: April 26, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)