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StrokeNCT04702815

Visual Dependence and Multisensory Balance Rehabilitation After Stroke

An observational study of Stroke and Balance; Distorted, run by Taipei Medical University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Stroke, Balance; Distorted, Gait, Unsteady
How many people
100 participants
Where
1 siteTaiwan
Study dates
1 Feb 2020to 14 Jan 2021
Phase
Observational
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

Study population: Chronic stroke patients with the first stroke will be recruited from the 3 departments of physical and rehabilitation medicine, regional hospitals.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Medical University

    Taipei, 110

Other trials in Taiwan

About this study

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

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.

Read the 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.

Medical subject headings
Stroke, Gait Disorders, Neurologic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Baseline

  2. 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: Baseline

  3. A history of falls

    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.

    Measured: Baseline

Secondary outcomes (9)

  1. Physical impairment of paretic leg and foot

    Physical impairment of paretic leg and foot will be assessed by the Chedoke-McMaster Stroke Assessment (CMSA) with scoring on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively). The higher stage indicates the better neurological recovery.

    Measured: Baseline

  2. 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: Baseline

  3. 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: Baseline

  4. Timed Up and Go test

    The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The longer duration (s) to complete the task represents the poorer balance.

    Measured: Baseline

  5. 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. Postural sway will be measured using an accelerometer attached on the lower back in 4 sensory conditions with visual and proprioceptive manipulation.

    Measured: Baseline

  6. 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: Baseline

  7. 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. Higher score represents more severe vertigo symptoms.

    Measured: Baseline

  8. 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: Baseline

  9. 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: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2021
  2. Study start1 Feb 2020
  3. Primary completion14 Jan 2021
  4. Study completion14 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04702815
Sponsor's protocol ID
N201912127
Status last verified
Feb 2021
First submitted
8 Dec 2020
Last updated
11 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Balance; Distorted, run by Taipei Medical University 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 6 inclusion and 3 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: finished, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived visual dependence (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04702815.

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.

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