Sensory Integration DysfunctionNCT04750668
Post-Stroke Visual Dependence and Multisensory Balance Rehabilitation
A study testing Multisensory Balance Training in people with Sensory Integration Dysfunction and Stroke, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Sensory Integration Dysfunction, Stroke
- What is being tested?
- Multisensory Balance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (1) other neurological disorders which could affect balance assessment
- (2) diagnosis with dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Stroke Visual Dependence and Early Intervention of Multisensory Balance Rehabilitation
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.
Read the 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.
- Conditions
- Sensory Integration Dysfunction, Stroke
- Being tested
- Multisensory Balance Training
- Keywords
- Visual dependence, Multisensory, Balance training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory Balance TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multisensory Balance Training Group | Experimental | Multisensory balance training manipulate sensory inputs of vision, vestibular and proprioception. Receives: Other: Multisensory Balance Training |
| Control Group | No intervention | Participants in control group maintain their regular activity without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline postural visual dependence at Week 4 and at Week 16
Secondary outcomes (8)
Five Times Sit to Stand Test
The Five Times Sit to Stand Test (5STS) evaluates functional lower extremity strength. Participants will be asked to sit to stand for 5 times as quickly as possible. The time to complete the task will be recorded. The shorter duration (s) represents the better muscle strength in lower limbs.
Measured: Change from Baseline Five Times Sit to Stand Test at Week 4 and at Week 16
Berg Balance Scale
The Berg balance scale (BBS) is used to objectively determine a participant's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. The total score is 56.
Measured: Change from Baseline Berg Balance Scale at Week 4 and at Week 16
Timed Up and Go test
Function mobility was assessed by the Timed Up and Go (TUG) test. Participants were instructed to stand up from a chair, walk 3 meters, turn around, and walk back to the chair sit down. Time (s) to complete the task was recorded. The more time taken is representative of the lower level of functional mobility.
Measured: Change from Baseline Timed Up and Go test at Week 4 and at Week 16
Modified Clinical Test of Sensory Integration and Balance
Modified Clinical Test of Sensory Integration and Balance (mCTSIB) is designed to assess how well an older adult is using sensory inputs when one or more sensory systems are compromised. The postural sway was measured in 4 sensory conditions through visual and proprioceptive manipulation using APDM Opal wireless sensors. The greater postural sway represents the poorer balance.
Measured: Change from Baseline Modified Clinical Test of Sensory Integration and Balance at Week 4 and at Week 16
Falls Efficacy Scale- International
Falls Efficacy Scale- International (FES-I) assesses subjects' concerns about falling. It consists of 16 questions related to everyday activities and subjects are asked to rate whether they were "not at all" (a score of 1), "somewhat" (2), "fairly" (3) or "very" (4) concerned about falling when doing that particular activity. The sum scores ranged 16 - 64 with higher scores indicating a greater fear of falling.
Measured: Change from Baseline Falls Efficacy Scale- International at Week 4 and at Week 16
Situational Vertigo Questionnaire
The Situational Vertigo Questionnaire (SVQ) is a 19-item questionnaire specifically aimed at identifying the presence of visual vertigo, a condition attributable to a defective vestibular compensation strategy, which is too dependent on the available visual information. patients to rate how much vertigo symptoms are provoked or exacerbated in environments with visual-vestibular conflict and yields a score for each item between 0 (not at all) to 4 (very much); a "never experienced" answer can be given if the patient has never experienced the described situation. The total score will be then calculated as the sum of single item scores divided per 19 minus the number of never experienced situations (total score/19-number of "never experienced" answer). Higher score represents more severe vertigo symptoms.
Measured: Change from Baseline Situational Vertigo Questionnaire at Week 4 and at Week 16
Gait pattern
Gait pattern will be evaluated using a Opal wireless system. Participants will be asked to walk in a 14-meter walkway. The first and final 2 meters are designed for acceleration and deceleration. The middle 10-meter will be analyzed only.
Measured: Change from Baseline Gait pattern at Week 4 and at Week 16
Barthel Index
The Barthel Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored. The total score is 100 and higher score represents more independent in ADL.
Measured: Change from Baseline Barthel Index at Week 4 and at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Integration DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei Jung Liang, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Pei-Jung Liang, MSc, Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750668
- Sponsor's protocol ID
- 09-M-141
- Status last verified
- Feb 2021
- First submitted
- 17 Jan 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Stroke Visual Dependence and Early Intervention of Multisensory Balance Rehabilitation
- ClinicalTrials.gov ID
- NCT04750668
- Acronym / sponsor ID
- 09-M-141
- Conditions
- Sensory Integration Dysfunction, Stroke
- Keywords
- Visual dependence, Multisensory, Balance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisensory Balance Training Group | Experimental | Other: Multisensory Balance TrainingMultisensory balance training manipulate sensory inputs of vision, vestibular and proprioception. |
| Control Group | No intervention | –Participants in control group maintain their regular activity without any intervention. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (2 listed)
- (1) other neurological disorders which could affect balance assessment
- (2) diagnosis with dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisensory Balance TrainingMultisensory 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. | Other | Multisensory Balance Training Group |
Primary outcome
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.
8 secondary outcomes
Five Times Sit to Stand Test
Time frame: Change from Baseline Five Times Sit to Stand Test at Week 4 and at Week 16
Berg Balance Scale
Time frame: Change from Baseline Berg Balance Scale at Week 4 and at Week 16
Timed Up and Go test
Time frame: Change from Baseline Timed Up and Go test at Week 4 and at Week 16
Modified Clinical Test of Sensory Integration and Balance
Time frame: Change from Baseline Modified Clinical Test of Sensory Integration and Balance at Week 4 and at Week 16
Falls Efficacy Scale- International
Time frame: Change from Baseline Falls Efficacy Scale- International at Week 4 and at Week 16
Situational Vertigo Questionnaire
Time frame: Change from Baseline Situational Vertigo Questionnaire at Week 4 and at Week 16
Gait pattern
Time frame: Change from Baseline Gait pattern at Week 4 and at Week 16
Barthel Index
Time frame: Change from Baseline Barthel Index at Week 4 and at Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Jung Liang, MSc principal investigator
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory Balance Training in people with Sensory Integration Dysfunction and Stroke, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Jung Liang, MSc (+88666289779 ext. 3519, peijungliang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived visual dependence (time frame: Change from Baseline perceived visual dependence at Week 4 and at Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.