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

Sponsor
Tan Tock Seng Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05322837
Collaborator
Rehabilitation Research Institute of Singapore (RRIS) (Other), Singapore-ETH Centre (SEC) (Other)
400
1
34.1
11.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment (FMA) [Inpatient: week 1 of admission]

    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.

  2. Nottingham Sensory Assessment (NSA) [Inpatient: week 1 of admission]

    The Erasmus NSA comprises of assessments of tactile sensation (light pressure, pressure, pinprick), sharp-blunt discrimination, two-point discrimination and proprioception.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tan Tock Seng Hospital Singapore Singapore

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Dr Karen Chua, MBBS, Tan Tock Seng Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT05322837
Other Study ID Numbers:
  • DSRB 2021/00919
First Posted:
Apr 12, 2022
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022