StrokeNCT04154969
The Effect of Vestibulo-ocular Reflex Improving Exercise on Gait and Balance Among Post Stroke Sub Acute Patients
A study testing Physiotherapy including Vestibular rehabilitation and conventional Physiotherapy in people with Stroke, run by Prof. Dan Justo at 1 site in Israel.
Trial summary
This study evaluate the effect of Vestibular rehabilitation program as part of physical therapy during rehabilitation post stroke. half of participants will receive vestibular exercise as part of the physiotherpy session, while the other half will receive a conservative physiotherapy session. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Physiotherapy including Vestibular rehabilitation and conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Nov 2019to Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- within 0-3 months of a stroke (ischemic or hemorrhagic; anterior or posterior circulation; not vertebro-basilar stroke).
Who cannot join
- any significant medical illness or blood pressure at rest>110/200 mmHg; a Mini-Mental State Exam score <24, global; a receptive aphasia or an inability to follow 2-point commands; unable to walk 16 meters with no physical assistance.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
yochay noach, B.PT, 03-5303396, yochay.noach@sheba.health.gov.il
About this study
This study evaluate the effect of Vestibular rehabilitation program as part of physical therapy during rehabilitation post stroke. half of participants will receive vestibular exercise as part of the physiotherpy session, while the other half will receive a conservative physiotherapy session.
Read the detailed description
Background Stroke global incidence is rising, in Israel 40% of the stroke patients are in need for hospitalized rehabilitation. Improving mobility, and in particular walking after stroke, is utterly important to reduce the risk of falling and is strongly correlated to higher patient autonomy and improved quality of life. During walking balance maintenance, is a complex function relying upon three modalities of sensory information. The sensory weighting process is compromised in stroke patients, so they are excessively reliant on visual information to control their posture. applying vestibular inputs, such as vestibulo-ocular reflex (VOR) habituation exercise, as part of vestibular focused rehabilitation (VR) is one of the methods to trigger sensory reweighting processes in post stroke patients. The VOR role in balance is to assist stabilizing images on the retina during head movement. It may be possible to explain the phenomena of head stabilization during gait in post stroke patients, as an attempt to maintain gaze stability due to reduced dynamic visual acuity (DVA) arising from decreased VOR function.
Aims The aims of this study are firstly to investigate the effectiveness of VOR exercise on gait speed and balance in post stroke patients with no dizziness, and secondly, to test the correlation between the efficiency of the VOR, as reflected by DVA and gait velocity.
Methods A prospective experimental study, randomized controlled, double blinded (assessor and statistician). Sixty adults, 65 years and older, hospitalized in the geriatric rehabilitation departments at the Sheba Medical Center, Israel will be divided to control and intervention groups. The intervention will include physiotherapy sessions including 10 minutes dedicated to VOR habituation exercise, comparing to physiotherapy sessions with no VOR exercise.
Prior to the baseline testing (T1), the participants will perform the outcome measures tests twice (two consecutive days) to determine the smallest real difference. Following this, the outcome measures will be tested at three time-points: before the beginning of the vestibular training (T1); three weeks later, at the termination of the vestibular training (T2) and three weeks after the termination of the training period (T3), to measure retention. For assessing gait and balance, the Dynamic Gait Index (appendix 1), the 10 Meters Walking Test (appendix 2) and the Timed Up and Go test (appendix 3) will be utilized. For assessing balance confidence the Activities-specific Balance Confidence Scale (ABC) questionnaire will be applied. For assessing the DVA, the Dynamic visual acuity test will be applied.
- Conditions
- Stroke
- Being tested
- Physiotherapy including Vestibular rehabilitation, conventional Physiotherapy
- Keywords
- balance, gait, post stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy including Vestibular rehabilitationOther
vestibular exercise (VOR TX1)
conventional PhysiotherapyOther
conventional Physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | daily physiotherapy session as part of the rehab plan, which includes 10 minutes of vestibular exercize. Receives: Other: Physiotherapy including Vestibular rehabilitation |
| control | Active comparator | daily physiotherapy session as part of the rehab plan Receives: Other: conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index
scoring walking while performing deferent tasks, such as walking around obstacle, turn head while walking.
Measured: 10 minute
10 Meters Walking Test
timing walking 10 meters walking
Measured: 1 minute
Timed Up and Go test
getting up from a chair, walk for 3 meters and back to the chair.
Measured: 1 minute
Activities-specific Balance Confidence Scale
questionnaire for balance confidence in deferent daily tasks
Measured: 5 minute
Dynamic visual acuity test
assessing the Vestibulo-ocular reflex by quantifying the visual acuity during head movement
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start10 Nov 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dan Justo
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Prof. Dan Justo, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154969
- Sponsor's protocol ID
- SHEBA-19-6371-DJ-CTIL
- Status last verified
- Sep 2021
- First submitted
- 5 Nov 2019
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2016 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 333 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1260-1344. doi: 10.1016/S0140-6736(17)32130-X.
PubMed 28919118ICDC. Stroke Registry Report for 2015-2016.; 2016. https://www.health.gov.il/publicationsfiles/stroke_registry_report_2014-2015.pdf.
Ifrah A, Arditi T, Sever L, Tanne D, Koton S. National acute stroke israeli survey (NASIS) 2010. Natl Acute Stroke Isr Surv 2010. 2010;(ICDC):1-43.
Tramontano M, Martino Cinnera A, Manzari L, Tozzi FF, Caltagirone C, Morone G, Pompa A, Grasso MG. Vestibular rehabilitation has positive effects on balance, fatigue and activities of daily living in highly disabled multiple sclerosis people: A preliminary randomized controlled trial. Restor Neurol Neurosci. 2018;36(6):709-718. doi: 10.3233/RNN-180850.
PubMed 30412513Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
PubMed 21205966Bonan IV, Marquer A, Eskiizmirliler S, Yelnik AP, Vidal PP. Sensory reweighting in controls and stroke patients. Clin Neurophysiol. 2013 Apr;124(4):713-22. doi: 10.1016/j.clinph.2012.09.019. Epub 2012 Oct 22.
PubMed 23088814Geurts AC, de Haart M, van Nes IJ, Duysens J. A review of standing balance recovery from stroke. Gait Posture. 2005 Nov;22(3):267-81. doi: 10.1016/j.gaitpost.2004.10.002. Epub 2004 Dec 7.
PubMed 16214666Sober SJ, Sabes PN. Flexible strategies for sensory integration during motor planning. Nat Neurosci. 2005 Apr;8(4):490-7. doi: 10.1038/nn1427. Epub 2005 Mar 27.
PubMed 15793578Keshner EA, Kenyon RV, Langston J. Postural responses exhibit multisensory dependencies with discordant visual and support surface motion. J Vestib Res. 2004;14(4):307-19.
PubMed 15328445Keshner EA, Kenyon RV. The influence of an immersive virtual environment on the segmental organization of postural stabilizing responses. J Vestib Res. 2000;10(4-5):207-19.
PubMed 11354434Ferre ER, Walther LE, Haggard P. Multisensory interactions between vestibular, visual and somatosensory signals. PLoS One. 2015 Apr 13;10(4):e0124573. doi: 10.1371/journal.pone.0124573. eCollection 2015.
PubMed 25875819Bonan IV, Colle FM, Guichard JP, Vicaut E, Eisenfisz M, Tran Ba Huy P, Yelnik AP. Reliance on visual information after stroke. Part I: Balance on dynamic posturography. Arch Phys Med Rehabil. 2004 Feb;85(2):268-73. doi: 10.1016/j.apmr.2003.06.017.
PubMed 14966712Ferre ER, Day BL, Bottini G, Haggard P. How the vestibular system interacts with somatosensory perception: a sham-controlled study with galvanic vestibular stimulation. Neurosci Lett. 2013 Aug 29;550(100):35-40. doi: 10.1016/j.neulet.2013.06.046. Epub 2013 Jul 1.
PubMed 23827220Tramontano M, Bergamini E, Iosa M, Belluscio V, Vannozzi G, Morone G. Vestibular rehabilitation training in patients with subacute stroke: A preliminary randomized controlled trial. NeuroRehabilitation. 2018;43(2):247-254. doi: 10.3233/NRE-182427.
PubMed 30040765Clendaniel RA. The effects of habituation and gaze stability exercises in the treatment of unilateral vestibular hypofunction: a preliminary results. J Neurol Phys Ther. 2010 Jun;34(2):111-6. doi: 10.1097/NPT.0b013e3181deca01.
PubMed 20588098
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibulo-ocular Reflex Improving Exercise on Gait and Balance Among Post Stroke Sub Acute Patients
- ClinicalTrials.gov ID
- NCT04154969
- Acronym / sponsor ID
- SHEBA-19-6371-DJ-CTIL
- Conditions
- Stroke
- Keywords
- balance, gait, post stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prof. Dan JustoOther government
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Nov 2019 (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.
This study evaluate the effect of Vestibular rehabilitation program as part of physical therapy during rehabilitation post stroke. half of participants will receive vestibular exercise as part of the physiotherpy session, while the other half will receive a conservative physiotherapy session.
Detailed description
Background Stroke global incidence is rising, in Israel 40% of the stroke patients are in need for hospitalized rehabilitation. Improving mobility, and in particular walking after stroke, is utterly important to reduce the risk of falling and is strongly correlated to higher patient autonomy and improved quality of life. During walking balance maintenance, is a complex function relying upon three modalities of sensory information. The sensory weighting process is compromised in stroke patients, so they are excessively reliant on visual information to control their posture. applying vestibular inputs, such as vestibulo-ocular reflex (VOR) habituation exercise, as part of vestibular focused rehabilitation (VR) is one of the methods to trigger sensory reweighting processes in post stroke patients. The VOR role in balance is to assist stabilizing images on the retina during head movement. It may be possible to explain the phenomena of head stabilization during gait in post stroke patients, as an attempt to maintain gaze stability due to reduced dynamic visual acuity (DVA) arising from decreased VOR function.
Aims The aims of this study are firstly to investigate the effectiveness of VOR exercise on gait speed and balance in post stroke patients with no dizziness, and secondly, to test the correlation between the efficiency of the VOR, as reflected by DVA and gait velocity.
Methods A prospective experimental study, randomized controlled, double blinded (assessor and statistician). Sixty adults, 65 years and older, hospitalized in the geriatric rehabilitation departments at the Sheba Medical Center, Israel will be divided to control and intervention groups. The intervention will include physiotherapy sessions including 10 minutes dedicated to VOR habituation exercise, comparing to physiotherapy sessions with no VOR exercise.
Prior to the baseline testing (T1), the participants will perform the outcome measures tests twice (two consecutive days) to determine the smallest real difference. Following this, the outcome measures will be tested at three time-points: before the beginning of the vestibular training (T1); three weeks later, at the termination of the vestibular training (T2) and three weeks after the termination of the training period (T3), to measure retention. For assessing gait and balance, the Dynamic Gait Index (appendix 1), the 10 Meters Walking Test (appendix 2) and the Timed Up and Go test (appendix 3) will be utilized. For assessing balance confidence the Activities-specific Balance Confidence Scale (ABC) questionnaire will be applied. For assessing the DVA, the Dynamic visual acuity test will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Physiotherapy including Vestibular rehabilitationdaily physiotherapy session as part of the rehab plan, which includes 10 minutes of vestibular exercize. |
| control | Active comparator | Other: conventional Physiotherapydaily physiotherapy session as part of the rehab plan |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- within 0-3 months of a stroke (ischemic or hemorrhagic; anterior or posterior circulation; not vertebro-basilar stroke).
Key exclusion criteria (1 listed)
- any significant medical illness or blood pressure at rest>110/200 mmHg; a Mini-Mental State Exam score <24, global; a receptive aphasia or an inability to follow 2-point commands; unable to walk 16 meters with no physical assistance.
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 |
|---|---|---|
| Physiotherapy including Vestibular rehabilitationvestibular exercise (VOR TX1) | Other | intervention |
| conventional Physiotherapyconventional Physiotherapy | Other | control |
Primary outcome
Dynamic Gait Index
Time frame: 10 minute
scoring walking while performing deferent tasks, such as walking around obstacle, turn head while walking.
10 Meters Walking Test
Time frame: 1 minute
timing walking 10 meters walking
Timed Up and Go test
Time frame: 1 minute
getting up from a chair, walk for 3 meters and back to the chair.
Activities-specific Balance Confidence Scale
Time frame: 5 minute
questionnaire for balance confidence in deferent daily tasks
Dynamic visual acuity test
Time frame: 5 minute
assessing the Vestibulo-ocular reflex by quantifying the visual acuity during head movement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Background: PubMed 28919118GBD 2016 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 333 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1260-1344. doi: 10.1016/S0140-6736(17)32130-X.
- BackgroundICDC. Stroke Registry Report for 2015-2016.; 2016. https://www.health.gov.il/publicationsfiles/stroke_registry_report_2014-2015.pdf.
- BackgroundIfrah A, Arditi T, Sever L, Tanne D, Koton S. National acute stroke israeli survey (NASIS) 2010. Natl Acute Stroke Isr Surv 2010. 2010;(ICDC):1-43.
- Background: PubMed 30412513Tramontano M, Martino Cinnera A, Manzari L, Tozzi FF, Caltagirone C, Morone G, Pompa A, Grasso MG. Vestibular rehabilitation has positive effects on balance, fatigue and activities of daily living in highly disabled multiple sclerosis people: A preliminary randomized controlled trial. Restor Neurol Neurosci. 2018;36(6):709-718. doi: 10.3233/RNN-180850.
- Background: PubMed 21205966Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
- Background: PubMed 23088814Bonan IV, Marquer A, Eskiizmirliler S, Yelnik AP, Vidal PP. Sensory reweighting in controls and stroke patients. Clin Neurophysiol. 2013 Apr;124(4):713-22. doi: 10.1016/j.clinph.2012.09.019. Epub 2012 Oct 22.
- Background: PubMed 16214666Geurts AC, de Haart M, van Nes IJ, Duysens J. A review of standing balance recovery from stroke. Gait Posture. 2005 Nov;22(3):267-81. doi: 10.1016/j.gaitpost.2004.10.002. Epub 2004 Dec 7.
- Background: PubMed 15793578Sober SJ, Sabes PN. Flexible strategies for sensory integration during motor planning. Nat Neurosci. 2005 Apr;8(4):490-7. doi: 10.1038/nn1427. Epub 2005 Mar 27.
- Background: PubMed 15328445Keshner EA, Kenyon RV, Langston J. Postural responses exhibit multisensory dependencies with discordant visual and support surface motion. J Vestib Res. 2004;14(4):307-19.
- Background: PubMed 11354434Keshner EA, Kenyon RV. The influence of an immersive virtual environment on the segmental organization of postural stabilizing responses. J Vestib Res. 2000;10(4-5):207-19.
- Background: PubMed 25875819Ferre ER, Walther LE, Haggard P. Multisensory interactions between vestibular, visual and somatosensory signals. PLoS One. 2015 Apr 13;10(4):e0124573. doi: 10.1371/journal.pone.0124573. eCollection 2015.
- Background: PubMed 14966712Bonan IV, Colle FM, Guichard JP, Vicaut E, Eisenfisz M, Tran Ba Huy P, Yelnik AP. Reliance on visual information after stroke. Part I: Balance on dynamic posturography. Arch Phys Med Rehabil. 2004 Feb;85(2):268-73. doi: 10.1016/j.apmr.2003.06.017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy including Vestibular rehabilitation and conventional Physiotherapy in people with Stroke, run by Prof. Dan Justo at 1 site in Israel.
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 1 inclusion and 1 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 10 Sep 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 Israel. 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 Yochay Noach, B.PT (+972-50-6798701, ynoach@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Gait Index (time frame: 10 minute). The study lists 5 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 NCT04154969, which also lists 29 linked publications.
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 10 Sep 2021.