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

NCT03831594 | Withdrawn

• 1 other identifier: 222784
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pusher Syndrome

Keywords

stroke; galvanic vestibular stimulation

Outcome Measures

Primary Outcomes (6)

• 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

  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

Secondary Outcomes (3)

• Subjective Visual Vertical

  Change from baseline, end of week 1 and end of week 2

• Subjective Postural Vertical

  Change from baseline, end of week 1 and end of week 2

• Subjective haptic vertical

  Change from baseline, end of week 1 and end of week 2

Study Arms (2)

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)

Device: Galvanic Vestibular Stimulation; Other: Standard Physiotherapy

Standard Physiotherapy

ACTIVE COMPARATOR

Standard Physiotherapy for 45 minutes a day for two weeks (five days per week)

Other: Standard Physiotherapy

Interventions

Galvanic Vestibular Stimulation DEVICE

Electrical current (under 1.5mA) applied to the mastoid processes to stimulate the balance organs in the inner ear

Standard Physiotherapy and Galvanic Vestibular Stimulation

Standard Physiotherapy OTHER

45 minutes of standard physiotherapy treating impairments and functional problems

Also known as: Standard Physical Therapy

Standard Physiotherapy; Standard Physiotherapy and Galvanic Vestibular Stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead
• Homerton University Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Imperial College London

London, W2 1PG, United Kingdom

Location

Related 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.

  PMID: 18617579 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

  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.

  PMID: 21097492 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.

  PMID: 9161984 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.

  PMID: 10358131 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.

  PMID: 12242549 BACKGROUND

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

  PMID: 14640870 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.

  PMID: 17385082 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.

  PMID: 24990006 BACKGROUND

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

  PMID: 14707298 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.

  PMID: 18678565 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.

  PMID: 21879800 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Diego Kaski, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 6, 2019
• Study Start: November 1, 2018
• Primary Completion: January 18, 2021
• Study Completion: January 20, 2021
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

GB (1)