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Clinical Trials/NCT04702815
NCT04702815
Completed
Not Applicable

Post-Stroke Visual Dependence and Early Intervention of Multisensory Balance Rehabilitation

Taipei Medical University1 site in 1 country100 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Taipei Medical University
Enrollment
100
Locations
1
Primary Endpoint
A history of falls
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This cross-sectional study aims to investigate the prevalence of post-stroke visual dependence, and the effects of visual dependence on balance and gait. It also determines whether visual dependence could differentiate stroke patients with a history of falls from without.

Detailed Description

Stroke participants will be recruited to measure the level of visual dependence, muscle strength, neurological recovery, balance ability, vertigo symptom, gait pattern and activities of daily living. This will calculate the prevalence of post-stroke visual dependence, and investigate the negative impact of visual dependence on balance and walking functions. This also determines whether the value of visual dependence could differentiate stroke patients with a history of falls from without a history of falls.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
January 14, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shu-Chun Lee

Principal Investigator

Taipei Medical University

Eligibility Criteria

Inclusion Criteria

  • first stroke with 20-80 years of age
  • the time since onset is more than 6 months
  • can walk independently at least 10 meters without any walking devices and orthosis
  • normal cognitive function with scoring more than 24 on the Mini Mental State Examination scale
  • can understand and follow commands
  • can give informed consent

Exclusion Criteria

  • other neurological disorders which could affect balance assessment
  • cerebellar stroke
  • diagnosis with central or peripheral vestibular diseases.

Outcomes

Primary Outcomes

A history of falls

Time Frame: Baseline

Any falls in the past year (n). Fall is defined by the inadvertently coming to rest on the ground, floor or other lower level, excluding intentional change in position to rest in furniture, wall or other objects. More than once fall is identified as faller.

Postural visual dependence

Time Frame: Baseline

Postural sway will be measured using an accelerometer attached on the lower back when participants are looking at blank wall, eyes closed and looking at rotating visual background. Greater postural sway in conditions with eyes closed and rotating visual background corresponding to looking at blank wall represents the higher level of postural visual dependence.

Perceived visual dependence

Time Frame: Baseline

Perceived visual dependence will be assessed using a computerized Rod and Disc Test (RDT). Participants will adjust a tilted rod to their subjective visual vertical with rotating visual background. The error (degrees) between subjective visual vertical and gravitational vertical will be measured and represented as the level of visual dependence. Higher error indicates higher level of perceived visual dependence.

Secondary Outcomes

  • Physical impairment of paretic leg and foot(Baseline)
  • Berg Balance Scale(Baseline)
  • Timed Up and Go test(Baseline)
  • Modified Clinical Test of Sensory Integration and Balance(Baseline)
  • Situational Vertigo Questionnaire(Baseline)
  • Gait pattern(Baseline)
  • Barthel index(Baseline)
  • Five Times Sit to Stand Test(Baseline)
  • Falls Efficacy Scale - International(Baseline)

Study Sites (1)

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