Combining Physical Therapy With Vestibular Stimulation to Improve Postural Stability in Pusher's Syndrome
NCT ID: NCT03831594
Last Updated: 2023-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-11-01
2021-01-20
Brief Summary
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Perceived verticality data will also be collected and analysed on age-matched controls. This data will be used to compare these results with the patients with PS.
The investigators hypothesis that GVS and standard Physiotherapy treatment will lead to a greater improvement in functional ability and awareness of perceived verticality compared to standard Physiotherapy alone.
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Detailed Description
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Patients with PS have shown to take longer to improve in rehabilitation than non-PS patients and tend to stay in hospital for longer.
Galvanic Vestibular Stimulation (GVS) involves passing a small electrical current behind the ear to stimulate the vestibular system to in-turn cause the head and body to move.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard Physiotherapy and Galvanic Vestibular Stimulation
Standard physiotherapy concurrently with Galvanic Vestibular Stimulation for 45 minutes a day for two weeks (five days per week)
Galvanic Vestibular Stimulation
Electrical current (under 1.5mA) applied to the mastoid processes to stimulate the balance organs in the inner ear
Standard Physiotherapy
45 minutes of standard physiotherapy treating impairments and functional problems
Standard Physiotherapy
Standard Physiotherapy for 45 minutes a day for two weeks (five days per week)
Standard Physiotherapy
45 minutes of standard physiotherapy treating impairments and functional problems
Interventions
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Galvanic Vestibular Stimulation
Electrical current (under 1.5mA) applied to the mastoid processes to stimulate the balance organs in the inner ear
Standard Physiotherapy
45 minutes of standard physiotherapy treating impairments and functional problems
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Consenting to participate in the trial
* 40 years old minimum age
* Consent to taking part in the trial
Exclusion Criteria
* Receptive aphasia
* Medical co-morbidities
* Opthalamic impairment
* Vestibular impairment
* Peripheral neuropathy
* Also any contraindications to GVS including:
* Brain metallic implants
* Pacemakers
* Recent brain surgery
* Skull defect
* Preceding epileptic seizures
* Sensitive skin behind the ears.
* Vestibular impairment
* History of medical/psychiatric/neurological disorders
* Currently taking any psychoactive medication
* Drunk more than 3 units of alcohol in the past 24 hours
ALL
Yes
Sponsors
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Homerton University Hospital NHS Foundation Trust
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Diego Kaski, PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College London
London, , United Kingdom
Countries
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References
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Baccini M, Paci M, Nannetti L, Biricolti C, Rinaldi LA. Scale for contraversive pushing: cutoff scores for diagnosing "pusher behavior" and construct validity. Phys Ther. 2008 Aug;88(8):947-55. doi: 10.2522/ptj.20070179. Epub 2008 Jul 10.
P. Azouvi (1996) Functional Consequences and Awareness of Unilateral Neglect: Study of an Evaluation Scale, Neuropsychological Rehabilitation, 6:2, 133-150, DOI: 10.1080/713755501
Maggie J. Bailey, M. Jane Riddoch & Peter Crome (2004) Test-retest stability of three tests for unilateral visual neglect in patients with stroke: Star Cancellation, Line Bisection, and the Baking Tray Task, Neuropsychological Rehabilitation, 14:4, 403-419, DOI: 10.1080/09602010343000282
Barra J, Marquer A, Joassin R, Reymond C, Metge L, Chauvineau V, Perennou D. Humans use internal models to construct and update a sense of verticality. Brain. 2010 Dec;133(Pt 12):3552-63. doi: 10.1093/brain/awq311. Epub 2010 Nov 19.
Day BL, Severac Cauquil A, Bartolomei L, Pastor MA, Lyon IN. Human body-segment tilts induced by galvanic stimulation: a vestibularly driven balance protection mechanism. J Physiol. 1997 May 1;500 ( Pt 3)(Pt 3):661-72. doi: 10.1113/jphysiol.1997.sp022051.
Fitzpatrick RC, Wardman DL, Taylor JL. Effects of galvanic vestibular stimulation during human walking. J Physiol. 1999 Jun 15;517 ( Pt 3)(Pt 3):931-9. doi: 10.1111/j.1469-7793.1999.0931s.x.
Karnath HO, Johannsen L, Broetz D, Ferber S, Dichgans J. Prognosis of contraversive pushing. J Neurol. 2002 Sep;249(9):1250-3. doi: 10.1007/s00415-002-0824-z.
Karnath HO, Broetz D. Understanding and treating "pusher syndrome". Phys Ther. 2003 Dec;83(12):1119-25.
Karnath HO. Pusher syndrome--a frequent but little-known disturbance of body orientation perception. J Neurol. 2007 Apr;254(4):415-24. doi: 10.1007/s00415-006-0341-6. Epub 2007 Mar 25.
Nakamura J, Kita Y, Yuda T, Ikuno K, Okada Y, Shomoto K. Effects of galvanic vestibular stimulation combined with physical therapy on pusher behavior in stroke patients: a case series. NeuroRehabilitation. 2014;35(1):31-7. doi: 10.3233/NRE-141094.
Parton A, Malhotra P, Husain M. Hemispatial neglect. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):13-21.
Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.
Utz KS, Korluss K, Schmidt L, Rosenthal A, Oppenlander K, Keller I, Kerkhoff G. Minor adverse effects of galvanic vestibular stimulation in persons with stroke and healthy individuals. Brain Inj. 2011;25(11):1058-69. doi: 10.3109/02699052.2011.607789. Epub 2011 Aug 31.
Other Identifiers
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222784
Identifier Type: -
Identifier Source: org_study_id
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