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

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ClinicalTrials.gov Identifier: NCT03831594
Recruitment Status : Withdrawn (We were unable to recruit any suitable patients to this study)
First Posted : February 6, 2019
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
Homerton University Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease Intervention/treatment Phase
Pusher Syndrome Device: Galvanic Vestibular Stimulation Other: Standard Physiotherapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Combining Physical Therapy With Vestibular Stimulation to Improve Postural Stability in Pusher's Syndrome
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : January 18, 2021
Actual Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: 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)
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
Other Name: Standard Physical Therapy

Active Comparator: Standard Physiotherapy
Standard Physiotherapy for 45 minutes a day for two weeks (five days per week)
Other: Standard Physiotherapy
45 minutes of standard physiotherapy treating impairments and functional problems
Other Name: Standard Physical Therapy




Primary Outcome Measures :
  1. Scale of Contraversive Pushing [ Time Frame: Change from baseline, end of week 1 and end of week 2 ]
    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.

  2. The Burke Lateropulsion Scale [ Time Frame: Change from baseline, end of week 1 and end of week 2 ]
    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

  3. Catherine Bergago Scale [ Time Frame: Change from baseline, end of week 1 and end of week 2 ]
    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).

  4. Mesulam's symbol cancellation test [ Time Frame: Change from baseline, end of week 1 and end of week 2 ]
    Mesulam's symbol cancellation test provides a measure of neglect, organisational process, and attention.

  5. Berg Balance Scale [ Time Frame: Change from baseline, end of week 1 and end of week 2 ]
    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

  6. Functional Impairment Measure [ Time Frame: Change from baseline, end of week 1 and end of week 2 ]
    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.


Secondary Outcome Measures :
  1. Subjective Visual Vertical [ Time Frame: Change from baseline, end of week 1 and end of week 2 ]
    Test of perceived visual vertical alignment

  2. Subjective Postural Vertical [ Time Frame: Change from baseline, end of week 1 and end of week 2 ]
    Test of perceived postural vertical alignment

  3. Subjective haptic vertical [ Time Frame: Change from baseline, end of week 1 and end of week 2 ]
    Test of perceived haptic vertical alignment



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831594


Locations
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United Kingdom
Imperial College London
London, United Kingdom, W2 1PG
Sponsors and Collaborators
Imperial College London
Homerton University Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Diego Kaski, PhD Imperial College London
Publications:
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

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03831594    
Other Study ID Numbers: 222784
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Imperial College London:
stroke
galvanic vestibular stimulation
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes