Clinical trial NCT04750668: Post-Stroke Visual Dependence and Multisensory Balance Rehabilitation
Official title: Post-Stroke Visual Dependence and Early Intervention of Multisensory Balance Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sensory Integration Dysfunction
Stroke
Keywords: Visual dependence
Multisensory
Balance training
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Perceived visual dependence
timeFrame: Change from Baseline perceived visual dependence at Week 4 and at Week 16
measure: Postural visual dependence
timeFrame: Change from Baseline postural visual dependence at Week 4 and at Week 16
Secondary outcomes:
measure: Five Times Sit to Stand Test
timeFrame: Change from Baseline Five Times Sit to Stand Test at Week 4 and at Week 16
measure: Berg Balance Scale
timeFrame: Change from Baseline Berg Balance Scale at Week 4 and at Week 16
measure: Timed Up and Go test
timeFrame: Change from Baseline Timed Up and Go test at Week 4 and at Week 16
measure: Modified Clinical Test of Sensory Integration and Balance
timeFrame: Change from Baseline Modified Clinical Test of Sensory Integration and Balance at Week 4 and at Week 16
measure: Falls Efficacy Scale- International
timeFrame: Change from Baseline Falls Efficacy Scale- International at Week 4 and at Week 16
measure: Situational Vertigo Questionnaire
timeFrame: Change from Baseline Situational Vertigo Questionnaire at Week 4 and at Week 16
measure: Gait pattern
timeFrame: Change from Baseline Gait pattern at Week 4 and at Week 16
measure: Barthel Index
timeFrame: Change from Baseline Barthel Index at Week 4 and at Week 16
Other outcomes:
measure: National Institutes of Health Stroke Scale
timeFrame: Baseline
measure: Mini Mental State Examination
timeFrame: Baseline
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Pei-Jung Liang, MSc
role: PRINCIPAL_INVESTIGATOR
References: