The SaeboGlove Evaluation Trial in Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of sessions performed using the SaeboGlove
研究概览
简要总结
This study evaluates the safety, feasibility and usability of a SaeboGlove rehabilitation device in the treatment of patients who have reduced ability to open their hand due to weakness after an acute stroke.
详细描述
The SaeboGlove is a new rehabilitation aid that can be used in people with hand weakness after a neurological injury. It assists the hand to open, which is crucial for people to grasp, and release everyday objects. It may improve function by doing this but may also help people with severe weakness take part more fully in therapy sessions. This glove is already marketed and is being used in some NHS sites. This trial will assess how it could be used in NHS practice in acute stroke patients and will develop a plan to implement this.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to consent
- •Aged ≥18 years
- •Diagnosis of stroke occurring ≤30 days ago
- •Reduced active range of movement wrist and / or finger extension
- •Modified ashworth score at wrist and fingers ≤ 2
- •Some initiation of gross active finger flexion
- •At least 10 degrees passive range of motion wrist extension
- •Considered able to learn to don / doff a SaeboGlove +/- help of willing carer
- •Ability to engage in some independent rehabilitation +/- help of willing carer
- •Considered able to comply with the requirements of protocol?
排除标准
- •Presence of >5-10 degrees digital contractures
- •Presence of other upper limb impairment that would influence participation (e.g. fixed contracture, frozen shoulder, severe arthritis or upper limb pain)
- •Presence of other conditions likely to influence participation (e.g. medically unstable, registered blind, terminal cancer, severe mood, cognitive or language issues)
- •Participating in another stroke rehabilitation trial
结局指标
主要结局
Number of sessions performed using the SaeboGlove
时间窗: One month
Feasibility
次要结局
- Number of adverse events related to using the SaeboGlove(One month)
- Therapy Intensity(Cumulative over one month)
- Motor Activity Log (MAL)(One month)
- Participant, Carer and Therapist Usability and Training Questionnaire(One month)
- Box and Block Test(One month)
- Action Research Arm Test (ARAT)(One month)
研究者
Dr Jesse Dawson
Clinical Reader
NHS Greater Glasgow and Clyde