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

Sponsor
Imperial College London (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03831594
Collaborator
Homerton University Hospital NHS Foundation Trust (Other)
0
Enrollment
1
Location
2
Arms
26.6
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Galvanic Vestibular Stimulation
  • Other: Standard Physiotherapy
 N/A

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 Design

Study Type:
Interventional
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 :
Nov 1, 2018
Actual Primary Completion Date :
Jan 18, 2021
Actual Study Completion Date :
Jan 20, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    3. 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).

    4. 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.

    5. 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

    6. 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.

    Secondary Outcome Measures

    1. Subjective Visual Vertical [Change from baseline, end of week 1 and end of week 2]

      Test of perceived visual vertical alignment

    2. Subjective Postural Vertical [Change from baseline, end of week 1 and end of week 2]

      Test of perceived postural vertical alignment

    3. Subjective haptic vertical [Change from baseline, end of week 1 and end of week 2]

      Test of perceived haptic vertical alignment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Imperial College London London United Kingdom W2 1PG

    Sponsors and Collaborators

    • Imperial College London
    • Homerton University Hospital NHS Foundation Trust

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Imperial College London
    ClinicalTrials.gov Identifier:
    NCT03831594
    Other Study ID Numbers:
    • 222784
    First Posted:
    Feb 6, 2019
    Last Update Posted:
    Jan 27, 2021
    Last Verified:
    Jan 1, 2021
    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:
    Syndrome

    Study Results

    No Results Posted as of Jan 27, 2021