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

November 7, 2023 updated by: Imperial College London

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1PG
        • Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Standard Physical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline, end of week 1 and end of week 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
Change from baseline, end of week 1 and end of week 2
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).
Change from baseline, end of week 1 and end of week 2
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.
Change from baseline, end of week 1 and end of week 2
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
Change from baseline, end of week 1 and end of week 2
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.
Change from baseline, end of week 1 and end of week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Visual Vertical
Time Frame: Change from baseline, end of week 1 and end of week 2
Test of perceived visual vertical alignment
Change from baseline, end of week 1 and end of week 2
Subjective Postural Vertical
Time Frame: Change from baseline, end of week 1 and end of week 2
Test of perceived postural vertical alignment
Change from baseline, end of week 1 and end of week 2
Subjective haptic vertical
Time Frame: Change from baseline, end of week 1 and end of week 2
Test of perceived haptic vertical alignment
Change from baseline, end of week 1 and end of week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Homerton University Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Diego Kaski, PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

January 18, 2021

Study Completion (Actual)

January 20, 2021

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 222784

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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