Combining Physical Therapy With Vestibular Stimulation to Improve Postural Stability in Pusher's Syndrome

Pusher Syndrome Clinical Trial

Official title:

Combining Physical Therapy With Vestibular Stimulation to Improve Postural Stability in Pusher's Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03831594
• Other study ID #: 222784
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 20, 2021

Study information

• Verified date: November 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 20, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Pusher Inclusion Criteria:

• Identified hemiparetic neglect - identified PS from a stroke or acquired brain injury (using the Scale of Contraversive Pushing and The Burke Lateropulsion Scale)
• Consenting to participate in the trial

Pusher Exclusion Criteria:

• Severe cognitive impairment
• 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.

Healthy volunteers inclusion criteria:

• 40 years old minimum age
• Consent to taking part in the trial

Healthy volunteers exclusion criteria:

• 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

Related Conditions & MeSH terms

• Pusher Syndrome
• Syndrome

Intervention

Device:
• Galvanic Vestibular Stimulation
Electrical current (under 1.5mA) applied to the mastoid processes to stimulate the balance organs in the inner ear

Other:
• Standard Physiotherapy
45 minutes of standard physiotherapy treating impairments and functional problems

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Homerton University Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Karnath HO, Broetz D. Understanding and treating "pusher syndrome". Phys Ther. 2003 Dec;83(12):1119-25. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

Parton A, Malhotra P, Husain M. Hemispatial neglect. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):13-21. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change from baseline, end of week 1 and end of week 2
Primary	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
Secondary	Subjective Visual Vertical	Test of perceived visual vertical alignment	Change from baseline, end of week 1 and end of week 2
Secondary	Subjective Postural Vertical	Test of perceived postural vertical alignment	Change from baseline, end of week 1 and end of week 2
Secondary	Subjective haptic vertical	Test of perceived haptic vertical alignment	Change from baseline, end of week 1 and end of week 2