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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03831594
Enrollment
0
Registered
2019-02-06
Start date
2018-11-01
Completion date
2021-01-20
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pusher Syndrome

Keywords

stroke, galvanic vestibular stimulation

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.

Interventions

Electrical current (under 1.5mA) applied to the mastoid processes to stimulate the balance organs in the inner ear

OTHERStandard Physiotherapy

45 minutes of standard physiotherapy treating impairments and functional problems

Sponsors

Homerton University Hospital NHS Foundation Trust
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Functional Impairment MeasureChange from baseline, end of week 1 and end of week 218-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.
Catherine Bergago ScaleChange from baseline, end of week 1 and end of week 2The 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).
Mesulam's symbol cancellation testChange from baseline, end of week 1 and end of week 2Mesulam's symbol cancellation test provides a measure of neglect, organisational process, and attention.
Berg Balance ScaleChange from baseline, end of week 1 and end of week 214-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
Scale of Contraversive PushingChange from baseline, end of week 1 and end of week 2This 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.
The Burke Lateropulsion ScaleChange from baseline, end of week 1 and end of week 2Test 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

Secondary

MeasureTime frameDescription
Subjective Postural VerticalChange from baseline, end of week 1 and end of week 2Test of perceived postural vertical alignment
Subjective haptic verticalChange from baseline, end of week 1 and end of week 2Test of perceived haptic vertical alignment
Subjective Visual VerticalChange from baseline, end of week 1 and end of week 2Test of perceived visual vertical alignment

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026