Combining Physical Therapy With Vestibular Stimulation to Improve Postural Stability in Pusher's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Berg Balance Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Galvanic Vestibular Stimulation (Device)
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)
干预措施: Standard Physiotherapy (Other)
Standard Physiotherapy
Standard Physiotherapy for 45 minutes a day for two weeks (five days per week)
干预措施: Standard Physiotherapy (Other)
结局指标
主要结局
Berg Balance Scale
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Subjective Visual Vertical(Change from baseline, end of week 1 and end of week 2)
- Subjective haptic vertical(Change from baseline, end of week 1 and end of week 2)
- Subjective Postural Vertical(Change from baseline, end of week 1 and end of week 2)