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
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26729394
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
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