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We were unable to recruit any suitable patients to this study
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| Name | Class |
|---|---|
| Homerton University Hospital NHS Foundation Trust | OTHER |
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The study is evaluating the effect of combining Galvanic Vestibular Stimulation (GVS) with standard Physiotherapy treatment in patients admitted to a neurological rehabilitation unit with Pusher syndrome (PS). Patients will be randomised to receive standard Physiotherapy treatment or standard treatment with GVS.
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.
Pusher syndrome (PS) can be described as disordered balance and orientation which causes patients to perceive they are in an upright position when in fact they are positioned towards their affected side. These patients use their unaffected limbs to 'push' themselves away from their unaffected side in an attempt to correct their perceived postural alignment. PS is a common disorder and can affect 16% of stroke patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Physiotherapy and Galvanic Vestibular Stimulation | Experimental | Standard physiotherapy concurrently with Galvanic Vestibular Stimulation for 45 minutes a day for two weeks (five days per week) |
|
| Standard Physiotherapy | Active Comparator | Standard Physiotherapy for 45 minutes a day for two weeks (five days per week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galvanic Vestibular Stimulation | Device | Electrical current (under 1.5mA) applied to the mastoid processes to stimulate the balance organs in the inner ear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scale of Contraversive Pushing | This is made up of 3 components: 1.The symmetry of spontaneous body posture (rated with 0, 0.25, 0.75, or 1 point. 1 = severe tilt, 0 = no tilt), 2. The use of non-paretic extremities (0, 0.5, or 1 point. 1 = performed spontaneously at rest), 3. The resistance to passive correction of the tilted posture (0 or 1 point. 1 = resistance occurs). For a diagnosis of Pusher Syndrome all 3 components need to be present. | Change from baseline, end of week 1 and end of week 2 |
| The Burke Lateropulsion Scale | Test of pushing. The score for each component is rated on a scale from 0 to 3 (0 to 4 for standing) and the score is based on the severity of resistance or the tilt angle when the patient begins to resist the passive movement. The score for diagnosis of Pusher behaviour is ≥2 points | Change from baseline, end of week 1 and end of week 2 |
| Catherine Bergago Scale | The Catherine Bergego Scale is a standardized checklist (10 everyday tasks) to detect presence and degree of neglect during observation of everyday life situations. The scale also provides a measure of neglect self-awareness (anosognosia).4 point rating scale indicating severity of neglect (0 = no neglect, 3 = severe neglect). | Change from baseline, end of week 1 and end of week 2 |
| Mesulam's symbol cancellation test | Mesulam's symbol cancellation test provides a measure of neglect, organisational process, and attention. | Change from baseline, end of week 1 and end of week 2 |
| Berg Balance Scale | 14-item scale designed to measure balance of the older adult in a clinical setting. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Visual Vertical | Test of perceived visual vertical alignment | Change from baseline, end of week 1 and end of week 2 |
| Subjective Postural Vertical | Test of perceived postural vertical alignment |
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Pusher Inclusion Criteria:
Pusher Exclusion Criteria:
Severe cognitive impairment
Receptive aphasia
Medical co-morbidities
Opthalamic impairment
Vestibular impairment
Peripheral neuropathy
Also any contraindications to GVS including:
Healthy volunteers inclusion criteria:
Healthy volunteers exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diego Kaski, PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | W2 1PG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18617579 | Background | 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. | |
| Background | 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 | ||
| Background | 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 | ||
| 21097492 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Standard Physiotherapy | Other | 45 minutes of standard physiotherapy treating impairments and functional problems |
|
|
| Change from baseline, end of week 1 and end of week 2 |
| Functional Impairment Measure | 18-item of physical, psychological and social function.The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. | Change from baseline, end of week 1 and end of week 2 |
| Change from baseline, end of week 1 and end of week 2 |
| Subjective haptic vertical | Test of perceived haptic vertical alignment | Change from baseline, end of week 1 and end of week 2 |
| Background |
| 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. |
| 9161984 | Background | 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. |
| 10358131 | Background | 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. |
| 12242549 | Background | 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. |
| 14640870 | Background | Karnath HO, Broetz D. Understanding and treating "pusher syndrome". Phys Ther. 2003 Dec;83(12):1119-25. |
| 17385082 | Background | 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. |
| 24990006 | Background | 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. |
| 14707298 | Background | Parton A, Malhotra P, Husain M. Hemispatial neglect. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):13-21. |
| 18678565 | Background | 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. |
| 21879800 | Background | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |