Is Intensive Upper Limb Rehabilitation Effective in Chronic Stroke Patients? A Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Fugl Meyer Upper Extremity Assessment
研究概览
简要总结
The evidence supporting routine provision of high-dose, high-intensity upper limb neurorehabilitation treatment for stroke survivors beyond the first few months after stroke is limited. The Queen Square Upper Limb (QSUL) programme provides 90 hours of upper limb neurorehabilitation over 3-weeks to chronic stroke survivors. The recently published service evaluation demonstrated encouragingly large, clinically meaningful effects at the level of activity and body function. An alternative way to deliver high doses of effective therapy is through technological developments, e.g. immersive interactive gaming environments such as the MindPod Dolphin programme.
The intention of this study is to provide stronger level evidence for intensive upper limb rehabilitation by conducting a randomised controlled trial of two different types of upper limb training compared to usual care. Patients considered suitable for the QSUL programme will be randomised to either: Group 1- intensive upper limb rehabilitation programme (QSUL); Group 2- MindPod programme; Group 3-wait-list control (who will be offered the treatment after the waiting list is complete).
The first aim of the study is to compare the effect of each type of high-dose, high-intensity upper limb training to usual care using measures of upper limb impairment and activity levels 3 months after treatment is complete.
The secondary aims are to comply with recent recommended by the Stroke Recovery and Rehabilitation Roundtable, and (i) investigate the effects of upper limb neurorehabilitation on kinematics of upper limb movement (using a KINARM exoskeleton), and (ii) use neuroimaging (MRI and EEG) and neurophysiological (TMS) measures to determine the characteristics of stroke survivors who are most likely to benefit from this treatment approach.
The results from this work will (i) help determine the impact of two methods of high dose, high intensity upper limb training in chronic stroke patients; (ii) identify whether there are any predictors of treatment response that will help stratify patients in future clinical trials of upper limb neurorehabilitation.
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
- 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
- •A first-ever unilateral stroke (ischaemic or haemorrhagic) as defined by WHO at least 6-months previously;
- •Moderate upper limb impairment as defined by Fugl-Meyer Upper Extremity (Woodbury et al., 2013) score between 19-46 (to avoid ceiling and floor effects);
- •Must be able to voluntarily extend the thumb and/or 2 or more fingers of the affected hand (10° or more)
排除标准
- •Other neurological diagnoses;
- •Serious communication, cognitive and language deficits (<7 on shortened version Montreal Cognitive Assessment or < 34 on Cognitive assessment scale for stroke patients);
- •Post-stroke frozen shoulder;
- •Increased muscle tone in wrist/finger extensors (≥3 on Modified Ashworth Scale);
- •Loss of passive range in any upper limb joints;
- •Fatigue of <30 on the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale;
- •Apraxia score of <5 on the TULIA assessment;
- •Severe shoulder pain measured by Chedoke Impairment Inventory: Stage of Shoulder Pain 1, 2, and 3;
- •Vision impairment that impedes seeing the television screen
结局指标
主要结局
Fugl Meyer Upper Extremity Assessment
时间窗: Three-months follow-up
Upper limb motor impairment measure, with a minimum score of 0 and a maximum score of 60 (excluding reflexes, Woodbury et al., 2007). A higher score means a better upper limb motor impairment outcome.
次要结局
- Electroencephalography(Baseline and 3 weeks post-intervention)
- Fugl Meyer Upper Extremity Assessment(Baseline and 3 weeks post-intervention)
- Action Research Arm Test(Baseline, 3 weeks post-intervention and three-months follow-up)
- Chedoke Arm and Hand Activity Inventory (CAHAI-13)(Baseline, 3 weeks post-intervention and three-months follow-up)
- Stroke Impact Scale(Baseline, 3 weeks post-intervention and three-months follow-up)
- Quality of life (EQ-5D5L)(Baseline, 3 weeks post-intervention and three-months follow-up)
- The stroke self-efficacy questionnaire(Baseline, 3 weeks post-intervention and three-months follow-up)
- Fugl Meyer Sensory Evaluation(Baseline, 3 weeks post-intervention and three-months follow-up)
- Montreal Cognitive Assessment (MOCA)(Baseline, 3 weeks post-intervention and three-months follow-up)
- Upper limb strength(Baseline, 3 weeks post-intervention and three-months follow-up)
- Transcranial magnetic stimulation(Baseline and 3 weeks post-intervention)
- Magnetic Resonance Imaging (3T)(Baseline)
- Kinematic measures- KINARM(Baseline, 3 weeks post-intervention and three-months follow-up)
- Kinematic measures- KINETIKOS(Baseline, 3 weeks post-intervention and three-months follow-up)
- Finger individuation(Baseline, 3 weeks post-intervention and three-months follow-up)