Clinical trial NCT03831594: Combining Physical Therapy With Vestibular Stimulation to Improve Postural Stability in Pusher's Syndrome
Official title: Combining Physical Therapy With Vestibular Stimulation to Improve Postural Stability in Pusher's Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pusher Syndrome
Keywords: stroke
galvanic vestibular stimulation
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Homerton University Hospital NHS Foundation Trust
First posted: 2019-02-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Scale of Contraversive Pushing
timeFrame: Change from baseline, end of week 1 and end of week 2
measure: The Burke Lateropulsion Scale
timeFrame: Change from baseline, end of week 1 and end of week 2
measure: Catherine Bergago Scale
timeFrame: Change from baseline, end of week 1 and end of week 2
measure: Mesulam's symbol cancellation test
timeFrame: Change from baseline, end of week 1 and end of week 2
measure: Berg Balance Scale
timeFrame: Change from baseline, end of week 1 and end of week 2
measure: Functional Impairment Measure
timeFrame: Change from baseline, end of week 1 and end of week 2
Secondary outcomes:
measure: Subjective Visual Vertical
timeFrame: Change from baseline, end of week 1 and end of week 2
measure: Subjective Postural Vertical
timeFrame: Change from baseline, end of week 1 and end of week 2
measure: Subjective haptic vertical
timeFrame: Change from baseline, end of week 1 and end of week 2
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College London
name: Diego Kaski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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