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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pusher Syndrome

Intervention / Treatment
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* Device: Galvanic Vestibular Stimulation
* Other: Standard Physiotherapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Physiotherapy and Galvanic Vestibular Stimulation<br>Standard physiotherapy concurrently with Galvanic Vestibular Stimulation for 45 minutes a day for two weeks (five days per week) | Device: Galvanic Vestibular Stimulation<br>* Electrical current (under 1.5mA) applied to the mastoid processes to stimulate the balance organs in the inner ear<br>Other: Standard Physiotherapy<br>* 45 minutes of standard physiotherapy treating impairments and functional problems<br>* Other names: Standard Physical Therapy;|
| Active Comparator: Standard Physiotherapy<br>Standard Physiotherapy for 45 minutes a day for two weeks (five days per week) | Other: Standard Physiotherapy<br>* 45 minutes of standard physiotherapy treating impairments and functional problems<br>* Other names: Standard Physical Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, galvanic vestibular stimulation