Post-Stroke Visual Dependence and Multisensory Balance Rehabilitation

NCT04750668 | Unknown

• 1 other identifier: 09-M-141
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensory Integration Dysfunction; Stroke

Keywords

Visual dependence; Multisensory; Balance training

Outcome Measures

Primary Outcomes (2)

• Perceived visual dependence

  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.

  Change from Baseline perceived visual dependence at Week 4 and at Week 16

• Postural visual dependence

  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.

  Change from Baseline postural visual dependence at Week 4 and at Week 16

Secondary Outcomes (8)

• 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

Other Outcomes (2)

• National Institutes of Health Stroke Scale

  Baseline

• Mini Mental State Examination

  Baseline

Study Arms (2)

Multisensory Balance Training Group

EXPERIMENTAL

Multisensory balance training manipulate sensory inputs of vision, vestibular and proprioception.

Other: Multisensory Balance Training

Control Group

NO INTERVENTION

Participants in control group maintain their regular activity without any intervention.

Interventions

Multisensory Balance Training OTHER

Multisensory Balance training includes 30 minutes per day, 5 days a week for 4 weeks, using visual, proprioceptive, and vestibular manipulations. The exercises involved movements of the eye, head, and body to stimulate the vestibular system, postural control exercises in different positions (feet together, tandem stance, and one leg stance), use of a soft surface to reduce the proprioceptive inputs, and exercises with closed eyes to deprive them of visual cues.

Multisensory Balance Training Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pei-Jung Liang, MSc

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Jung Liang, MSc

CONTACT

+88666289779; peijungliang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: February 11, 2021
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

TW (1)