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

Not Applicable

Withdrawn

• Conditions: Pusher Syndrome
• Interventions: Device: Galvanic Vestibular Stimulation; Other: Standard Physiotherapy

• Registration Number: NCT03831594
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-06
• Primary Completion: 2021-01-18
• Study Completion: 2021-01-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Physiotherapy and Galvanic Vestibular Stimulation	Galvanic Vestibular Stimulation	Standard physiotherapy concurrently with Galvanic Vestibular Stimulation for 45 minutes a day for two weeks (five days per week)
Standard Physiotherapy	Standard Physiotherapy	Standard Physiotherapy for 45 minutes a day for two weeks (five days per week)
Standard Physiotherapy and Galvanic Vestibular Stimulation	Standard Physiotherapy	Standard physiotherapy concurrently with Galvanic Vestibular Stimulation for 45 minutes a day for two weeks (five days per week)

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale	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
Catherine Bergago Scale	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).
The Burke Lateropulsion Scale	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
Mesulam's symbol cancellation test	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.
Functional Impairment Measure	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.
Scale of Contraversive Pushing	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.

Secondary Outcome Measures

Name	Time	Method
Subjective Visual Vertical	Change from baseline, end of week 1 and end of week 2	Test of perceived visual vertical alignment
Subjective haptic vertical	Change from baseline, end of week 1 and end of week 2	Test of perceived haptic vertical alignment
Subjective Postural Vertical	Change from baseline, end of week 1 and end of week 2	Test of perceived postural vertical alignment

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom