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Recruiting NCT05322837

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

— Observational Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical and technological-aided assessments and questionnaires.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 21 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Fugl-Meyer Assessment (FMA) [Time frame: Inpatient: week 1 of admission]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Singapore · 1 center
  • Tan Tock Seng Hospital — Singapore

Publications

  • 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 3 PMID 38107648

Identifiers

NCT: NCT05322837 · DSRB 2021/00919

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗