Skip to main content
Clinical Trials/NCT04750668
NCT04750668
Unknown
Not Applicable

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

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation1 site in 1 country80 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sensory Integration Dysfunction
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Enrollment
80
Locations
1
Primary Endpoint
Perceived visual dependence
Last Updated
5 years ago

Overview

Brief Summary

Stroke patients have higher levels of visual dependence, which affects orientation, balance and gait. Visual adaption or habituation training aiming to decrease visual sensitivity and tolerance, is commonly used to decrease the levels of visual dependence. However, the visual adaption training often evokes unbearable vertigo, resulting in lower compliance to training program. In addition, stroke patients who have higher visual dependence may not have the symptom of dizziness. Therefore, it is unclear whether visual adaption training has similar effects on stroke patients. Visual dependence is considered as a sensory reweighting deficit and therefore visual dependence could be improved through multisensory balance training which comprises of visual, vestibular, and proprioceptive manipulation. This study will investigate the effects of early multisensory balance training on visual dependence, balance and gait in subacute stroke patients.

Detailed Description

A total of 80 subacute stroke participants will be randomly assigned to either experimental and control groups. Participants in the experimental group will receive multisensory balance training while those in the control group will maintain their regular care. All participants will be assessed their levels of visual dependence, motor ability, balance and gait, vertigo symptom and activities of daily living before and after intervention program as well as at 3-month follow-up.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
February 28, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pei Jung Liang

Principal Investigator

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Eligibility Criteria

Inclusion Criteria

  • (1) first stroke with 20-80 years of age
  • (2) the time since onset is less than 6 months
  • (3) able to stand independently without any devices
  • (4) can understand and follow commands
  • (5) can give informed consent.

Exclusion Criteria

  • (1) other neurological disorders which could affect balance assessment
  • (2) diagnosis with dementia.

Outcomes

Primary Outcomes

Perceived visual dependence

Time Frame: Change from Baseline perceived visual dependence at Week 4 and at Week 16

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.

Postural visual dependence

Time Frame: Change from Baseline postural visual dependence at Week 4 and at Week 16

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.

Secondary Outcomes

  • Five Times Sit to Stand Test(Change from Baseline Five Times Sit to Stand Test at Week 4 and at Week 16)
  • Berg Balance Scale(Change from Baseline Berg Balance Scale at Week 4 and at Week 16)
  • Timed Up and Go test(Change from Baseline Timed Up and Go test at Week 4 and at Week 16)
  • Modified Clinical Test of Sensory Integration and Balance(Change from Baseline Modified Clinical Test of Sensory Integration and Balance at Week 4 and at Week 16)
  • Falls Efficacy Scale- International(Change from Baseline Falls Efficacy Scale- International at Week 4 and at Week 16)
  • Situational Vertigo Questionnaire(Change from Baseline Situational Vertigo Questionnaire at Week 4 and at Week 16)
  • Gait pattern(Change from Baseline Gait pattern at Week 4 and at Week 16)
  • Barthel Index(Change from Baseline Barthel Index at Week 4 and at Week 16)

Study Sites (1)

Loading locations...

Similar Trials