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临床试验/ISRCTN16489086
ISRCTN16489086已完成未知

Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm - a feasibility study

niversity of Nottingham0 个研究点目标入组 40 人开始时间: 2015年1月15日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
40

研究概览

简要总结

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Eligibility criteria – patient participants for the feasibility RCT
  • 1. Patients with a confirmed clinical diagnosis of stroke AND it is their first stroke event to affect their upper limb
  • 2. Patients aged 18 years or over
  • 3. Impaired arm movement and strength resulting in reduced function, caused specifically by the stroke. (as determined by the arm subsection score of the National Institute for Health Stroke Scale (NIHSS)
  • Carer participants for the feasibility RCT Inclusion criteria
  • 1. Nominated carer for a patient participating in the feasibility RCT
  • Eligibility criteria – Patient and carer interviews
  • 1. Participating in the main feasibility RCT
  • 2. Mental capacity to consent and take part in the interview
  • 3. Able to understand English
  • 4. Nominated carer supporting a participant in the main feasibility RCT
  • 5. Mental capacity to consent and take part in the interview
  • 6. Able to understand English
  • Therapist Focus Discussion Groups
  • 1. HCPC registered occupational therapist or physiotherapist
  • 2. Currently employed by NUH NHS Trust and working on the Nottingham Stroke Unit
  • 3. Experience of supporting at least one participant to use the ES intervention

排除标准

  • Patient participants for the feasibility RCT
  • 1. Patients with a previous history of stroke affecting their upper limb will be excluded as a chronic limb condition from a previous stroke could affect the results
  • 2. Patients will also be excluded with peripheral nerve injury of the upper limb; an existing orthopaedic condition affecting the upper limb; fixed contractures at the elbow, wrist or fingers; malignancy in the area of the ES electrode placement; or epilepsy
  • 3. Patients with a cardiac pacemaker or similar implanted device.
  • 4. Pregnancy
  • 5. Undiagnosed pain or skin conditions (i.e. not related to the stroke)
  • Carer participants for the feasibility RCT
  • 1. Non English speaking
  • Patient and carer interviews
  • 1. Individual is unable to communicate verbally or in written form
  • 2. NonEnglish speaking
  • 3. Aged younger than 18 years
  • 1. Individual is unable to communicate verbally or in written form
  • 2. NonEnglish speaking
  • 3. Aged younger than 18 years

研究者

发起方
niversity of Nottingham

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