To Investigate the Potential Effectiveness of Mirror Aided Cross Education Using the Innovative 'Mirror Strengthening Device' Compared to Mirror Therapy Alone in Post Stroke Upper Limb Rehabilitation: A Pilot Randomised Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Isokinetic Upper Limb Strength
研究概览
简要总结
This is a pilot randomised controlled trial investigating a combination of mirror therapy and cross-education training compared to mirror therapy alone for the rehabilitation of upper limb impairment following a stroke. A case study series will be completed in advance of the full randomised controlled trial.
The outcome measure assessments will take place at the institution. All intervention therapy sessions will be completed by the participant in their own home with the first introductory session being completed with the lead researcher. The study will be conducted in conjunction with Sligo University Hospital once it has attained ethical approval through the relevant University Hospital Ethics Committee.
详细描述
The study will require participants with chronic stroke to perform an upper limb Home Exercise Program (HEP) in their own home.
INTERVENTION:
Experimental Group Experimental participants will perform task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will pull a resistance cord with their non-affected arm, while looking at its reflection in a mirror covering their affected arm. The untrained limb will be positioned in a similar position to the training limb, supported on the table behind the exercise device.
Examples of the exercises include bringing the arm out to the side and up in the air (reaching style movement). The initial resistance will be chosen based on the participant's initial outcome measure results.
Repetitions of these exercises will be prescribed according to patient function and strength and will be increased each week as their ability improves. Sessions will start with 20-minute durations and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Experimental participants will perform resisted task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will pull a resistance cord with their non-affected arm, while looking at its reflection in a mirror covering their affected arm.
Control participants will perform non-resisted task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will be watching their non-affected arm reflected in a mirror covering their affected arm.
The outcome assessor was blinded to treatment allocation. They evaluated participants in a separate lab and were asked not to discuss the treatment given to patients. Even if the the patient mentioned the trials they would discuss the fact that they were using Mirrors.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ischemic or hemorrhagic stroke as determined by a stroke neurologist. Stroke will be defined as an acute event of cerebrovascular origin causing focal or global neurologic dysfunction lasting more than 24 hours diagnosed by a neurologist/gerontologist, and confirmed by computed tomography or magnetic resonance imaging.
- •≥3 months post stroke; with no restrictions on how long post stroke.
- •Discharged from formal physiotherapy rehabilitation services.
- •Unilateral upper limb weakness with a Medical Research Council (MRC) Scale for Strength score greater than 2 (i.e., movement with influence of gravity removed) in the limb to be assessed and treated.
- •Functional active range of movement and power in non-hemiparetic side.
- •Ambulatory with or without use of a walking device. Must be able to transfer into the Biodex machine.
- •Older than 18 yrs.
- •Not involved in any other type of structured strength training for the duration of the study.
排除标准
- •Diagnosis of additional neurological condition (including more than one stroke) or cardiovascular disease.
- •Presence of musculoskeletal conditions affecting the bones and/or soft tissues of the upper extremity.
- •Impaired cognition that would affect ability to informed consent (MMSE <21).
- •Presence of aphasia or visual impairments.
- •Medications affecting tone less than 3/12 prior.
结局指标
主要结局
Isokinetic Upper Limb Strength
时间窗: 4 weeks.
(Biodex System 4 Pro with advantage software) IPRS Limited, Suffolk House, Bramford Road, Little Blakenham, Suffolk, IP8 4JU. A higher score indicates more strength.
次要结局
- Modified Ashworth Scale (MAS) for spasticity.(4 weeks.)
- Upper limb range of movement.(4 weeks.)
- Fugl Meyer Upper Extremity Test(4 weeks.)
- Stroke Impact Scale measures Handicap.(4 weeks.)
研究者
Kenneth Monaghan
Research Supervisor & Head of Neuroplasticity Research Group (NRG)
Institute of Technology, Sligo