A Pilot Randomized Controlled Trial (RCT) of Mirror Box Therapy in Upper Limb Rehabilitation With Sub-acute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Functional Independence Measure v4 at 3 months post-discharge
研究概览
简要总结
Individuals who have sustained a stroke are often left with residual deficits of the upper limb such as impaired movement and sensation. These deficits restrict functional use of the limb in everyday activities and can result in increased dependency upon others to engage in some tasks. Regaining independence through functional use of the arm and hand is an aim of occupational therapy rehabilitation. Mirror box therapy (MBT) is a relatively new innovation being introduced into occupational therapy interventions. Some studies have reported it to be beneficial in upper limb rehabilitation, however, these studies have not involved a sub-acute stroke population. This pilot study aims to provide robust evidence, using RCT design, as to whether this type of therapy may offer greater potential in functional gains in the sub-acute recovery period of stroke than standard rehabilitation of the upper limb alone.
详细描述
Introduction. Stroke is a major cause of mortality in the United Kingdom with around 111,000 people per year being newly diagnosed. Of the survivors, 50% will be left with significant, long-term effects including residual deficits of the upper limb. Rehabilitation of upper limb impairment rests with the OT who plays a vital role in enabling stroke patients to self-manage their condition and live optimally independent lives. Mirror box therapy (MBT) is a relatively new therapeutic intervention that is gaining recognition within OT for the potential it offers in rehabilitation of upper limb function in stroke patients. Based upon mirror visual feedback originally used in the treatment of phantom limb pain after amputation, neural recovery in the brain can be stimulated using mirrored movements of the non-affected upper limb. It is thought that visual feedback helps recruit dormant motor pathways that replace the damaged pathways and encourage the return of movement, thus mirror box therapy is thought to improve upper limb function through both movement and mental stimulation. However, existing studies are limited due to non- consistent participant post-stroke delay (ranging from 3-12 months). Few studies have included patients in the sub- acute period post stroke (0-3 months), a population considered most likely to benefit from this therapy at the early recovery stage.
Aims and Objectives. The aim of this pilot study is therefore to explore the feasibility of conducting a fully powered randomized controlled trial of mirror box therapy for upper limb rehabilitation within a sub-acute stroke population.
The objectives of the study are to:
- Evaluate the feasibility of patient recruitment within an in-patient sub-acute single setting;
- Assess the feasibility of delivering MBT as a component of OT treatment in the sub-acute in-patient population;
- Evaluate the sensitivity of the outcome measures for use in a fully powered trial and conduct a power calculation;
- Conduct a preliminary analysis of the data to identify potential treatment gains within and between the 2 groups;
- Pilot the collection of data to enable cost-consequence analysis to be undertaken as an output of the main RCT.
Sample: 50 participants will be recruited and randomized into two groups (treatment n=25; control n=25) over a 2 year period of 1 January 2015 - 31st Dec 2016.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •18 years and over;
- •newly admitted inpatient of the rehabilitation ward;
- •diagnosis of CVA in the last three months resulting in upper limb motor loss;
- •able to follow two part spoken or written commands in the English language;
- •upper limb therapy designated as a main portion of goal directed treatment programme;
- •consent to take part in the study.
排除标准
- •patients who have had a previous CVA
- •patients who have gross cognitive impairment
- •patients who are unable to understand two part spoken/ written commands in English.
研究组 & 干预措施
Mirror Box Treatment Group
Participants in the intervention group will be required to perform two 20 minute sessions of Mirror Box Therapy, five days/week for the duration of their in-patient stay carried out under the direction of members of the OT stroke team as well as receiving their standard OT treatment for upper limb rehabilitation for the duration of their in-patient stay, which is 3-5 sessions per week of approximately 45 minutes duration. This classic rehabilitation treatment is based upon neurodevelopmental theory using the Bobath approach of postural control and repetitive task training.
干预措施: Mirror Box Therapy (Other)
Conventional Therapy Control Group
Participants in the control group shall receive their standard OT treatment for upper limb rehabilitation for the duration of their in-patient stay, which is 3-5 sessions per week of approximately 45 minutes duration. This classic rehabilitation treatment is based upon neurodevelopmental theory using the Bobath approach of postural control and repetitive task training.
结局指标
主要结局
Change in Functional Independence Measure v4 at 3 months post-discharge
时间窗: Baseline and 3 months
The FIM/FAM (Version 4) is an 18 item measure of 6 areas of function (self-care; sphincter control; mobility; locomotion; communication and social cognition) grouped into two domains of motor items and cognitive items. Each item is scored on a 7-point likert scale and the score indicates the amount of assistance required to perform each item (ranging from 1 representing total assistance in all areas to 7 representing total independence in all areas), and has been widely used post-stroke18.
Change in Functional Independence Measure v4 at 6 months post-discharge
时间窗: Baseline and 6 months
The FIM/FAM (Version 4) is an 18 item measure of 6 areas of function (self-care; sphincter control; mobility; locomotion; communication and social cognition) grouped into two domains of motor items and cognitive items. Each item is scored on a 7-point likert scale and the score indicates the amount of assistance required to perform each item (ranging from 1 representing total assistance in all areas to 7 representing total independence in all areas), and has been widely used post-stroke18.
Change in Functional Independence Measure v4 at 6 weeks
时间窗: Baseline and 6 weeks.
The FIM/FAM (Version 4) is an 18 item measure of 6 areas of function (self-care; sphincter control; mobility; locomotion; communication and social cognition) grouped into two domains of motor items and cognitive items. Each item is scored on a 7-point likert scale and the score indicates the amount of assistance required to perform each item (ranging from 1 representing total assistance in all areas to 7 representing total independence in all areas), and has been widely used post-stroke18.
次要结局
- Change in EQ-5D-5L15 at 6 months post-discharge(Baseline and 6 months.)
- Change in Graded Wolf Motor Function Test (gWMFT) at 3 months post-discharge(Baseline and 3 months.)
- Change in EQ-5D-5L15 at 3 months post-discharge(Baseline and 3 months.)
- Change in Graded Wolf Motor Function Test (gWMFT) at 6 weeks(Baseline and 6 weeks.)
- Change in EQ-5D-5L15 at 6 weeks(Baseline and 6 weeks.)
- Change in Graded Wolf Motor Function Test (gWMFT) at 6 months post-discharge(Baseline and 6 months.)
- Change in Canadian Occupational Performance Measure (COPM) at 3 months post-discharge(Baseline and 3 months.)
- Change in Canadian Occupational Performance Measure (COPM) at 6 months post-discharge(Baseline and 6 months.)
研究者
Dr Alison Porter-Armstrong
Senior Lecturer in Rehabilitation Sciences
University of Ulster