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临床试验/NCT04874181
NCT04874181已完成不适用

A Proof Of Concept Single Arm Study To Use Virtual Reality in Rehabilitation of Stroke Patients in Neuro Intensive Care Unit in Tan Tock Seng Hospital

Tan Tock Seng Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
estimate how much a patient can do compared to his/her baseline in terms of ability to stand/ambulation/reaching out for objects based on the physiotherapist who first saw the patient.

研究概览

简要总结

Use of SIlverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee strength

详细描述

Either 1 of 3 physiotherapists will recruit the patient from NICU if the GCS is 14 - 15. Silverfit 3D will then be used for 20 minutes each day to train the knee and arm strength until the patient's discharge from ICU. Baseline muscle strength will be measured and graded by the physiotherapist using Medical Research Council grading then followed up by the same physiotherapist on discharge from ICU and on discharge from hospital.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients 21 - 90 years old
  • •Diagnosis of stroke of pure motor/sensory type affecting the limbs, all levels of severity and at all stages post stroke, defined by the WHO as "a syndrome of rapidly developing symptoms and signs of focal, and at times global, loss of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin" (WHO 1989), diagnosed by imaging or neurological examination
  • •GCS 14 - 15
  • •RASS -1 to +1
  • •Blood pressure within 20% of patient's baseline
  • •Muscle power at least 2 out of 5 on the affected side, as assessed by the physiotherapist or clinician

排除标准

  • •Age less than 21 or more than 90 years old
  • •Neurological instability
  • •Poor prognosis/expected withdrawal of treatment/palliative care patient
  • •Visual loss/hearing loss
  • •Active delirium with inability to cooperate as determined by CAM-ICU positivity
  • •Severe cognitive impairment/dementia
  • •Haemodynamic instability

研究组 & 干预措施

Silverfit 3D

Experimental

The subject will use SIlverfit 3D for rehabilitation of his/her shoulder/knee strength post stroke.

干预措施: Silverfit 3D (Device)

结局指标

主要结局

estimate how much a patient can do compared to his/her baseline in terms of ability to stand/ambulation/reaching out for objects based on the physiotherapist who first saw the patient.

时间窗: 3 months

Patients will be interviewed on admission by the physiotherapist to find out his/her baseline activities of daily living/strength and limb power. Physiotherapists will assess the patient again on day of discharge to find out how much the patient is able to return to his/her baseline post stroke. This is a descriptive outcome measure as it is only measured by 1 physiotherapist who has seen the patient on admission and then on discharge from hospital.

To estimate an improvement in muscle strength using the Medical Research Council (MRC) grading following the intervention.

时间窗: 3 months

Use of MRC grade to estimate improvement in muscle strength by a group of trained physiotherapists before, during and after the use of virtual reality equipment.

increase frequency and intensity of rehab activities in stroke patients

时间窗: 6 months

To increase frequency of rehab activities in patients in terms of percentage of patients who can do, time of each exercise

次要结局

  • reduce length of stay in ICU(3 months)

研究者

发起方
Tan Tock Seng Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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