A Multicentre Pilot Randomised Control Trial of an Adapted Mobile Rehabilitation System for Self-directed Rehabilitation and Improved Upper Limb Outcomes in Stroke Survivors With Upper Limb Weakness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment- Upper Extremity (FM-UE)
研究概览
简要总结
A pilot multicentre randomised control trial (RCT), examining upper limb (UL) outcomes amongst stroke survivors implementing a technology-based, self-directed UL intervention as an adjunct to conventional care.
详细描述
Title: A multicentre pilot randomised control trial (RCT) of an adapted mobile rehabilitation system (GripAble) for self-directed upper limb (UL) rehabilitation and improved UL outcomes in stroke survivors with UL weakness.
Design: Interventional (clinical trial). A multicentre pilot RCT, parallel design, comparing intervention group (self-selected dose of self-directed technology-based UL exercise as an adjunct to conventional care) with a control group receiving conventional care only. A mixed methods research design will be implemented. This will be an assessor-blinded protocol, due to the nature of the intervention, participants cannot be blinded. This will be an internal pilot, if no changes are made to the protocol and additional funding is secured, the data from this pilot work will be used be used as part of an adequately powered RCT.
Aims: To test research design considerations in preparation for a definitive multicentre RCT. To explore the hypothesis that stroke survivors with UL weakness will engage in self-directed exercise (without direct professional supervision) as an adjunct to conventional care and demonstrate significant improvement in UL outcomes when provided with an adapted mobile rehabilitation system, compared with a control group participating in conventional care only.
Outcome Measures: The primary end point outcome will be based on intention to treat analysis on the Fugl Meyer Upper Extremity Assessment (FM-UE) at 6months post randomisation, controlled for baseline.
Additional/ secondary outcome measures will include: The Action Arm Research Test (ARAT), Apple watch activity monitors (implementing tailor-made machine learning methods to interpret UL movement data), Barthel Index (BI), Modified Rankin Scale (mRS), Hospital Anxiety and Depression Scale (HADS), Faces Pain Rating Scale (FPRS), Stanford Fatigue Visual Numeric Scale (SFVNS).
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)
盲法说明
This will be an assessor-blinded protocol, due to the nature of the intervention, participants cannot be blinded.
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
- •Cognitive status that would permit for use /supported use of intervention device and engagement in protocol related trainings/assessment. To be indicated by treating clinician at point of screening, formal capacity assessment to be conducted as/if appropriate. Easy read patient information sheet (PIS) and training materials will be implemented to support patients presenting with specific cognitive and/or communication needs.
- •Stroke diagnosis (can be first or subsequent stroke, unilateral haemorrhagic or ischemic) 4 weeks max post stroke at time of recruitment.
- •Can communicate in English, that is, sufficient for completion of intervention and outcome measures. It is advisable that a decision to include or exclude those with significant expressive or receptive communication impairment should be made following consultation with the treating speech and language therapist (SLT) to ensure all reasonable accommodations are made to support participation.
- •UL motor deficit post stroke (bilateral/unilateral) (according to National Institutes of Health Stroke Score (NIHSS) item 5), distal UL power >1 /5 on the Oxford Rating Scale (Medical Research Council Manual Muscle Testing scale) or voluntary finger extension of the thumb and/or two or more fingers of the affected hand (to 10° or more). The presence of sensory impairment (including neglect syndrome) or movement disorder (apraxia) is not a contraindication to enrolment as long as there is a concurrent motor deficit (as described above).
排除标准
- •Patients already enrolled an interventional neuro rehabilitation trial.
- •Patients enrolled in clinical trials that contraindicate co-enrolment.
- •Patients presenting with unstable medical conditions/medical contraindications as determined by treating medical consultant (these patients may be approached at a later date should their condition improve).
- •Patients with uncontrolled photosensitive epilepsy/Other neurological symptoms that may be exacerbated by required focus on light emitting diode (LED) screen/moving object on screen).
- •Those registered blind/with uncompensated/uncorrected visual deficits.
- •Behavioural/affective dysfunction which could influence the ability of the person to engage with the research protocol and/or pose risk to the participating researchers (in circumstances such as follow-up community visits).
- •Other concomitant neurological disorders affecting upper extremity motor function (Multiple Sclerosis, Spinal Cord Injury, Brachial Plexus or Radial Nerve Injury).
- •Unremitting arm pain at rest.
- •Pre-existing UL impairment with known and significant disruption to range of motion, motor or functional performance (fracture, arthritic changes, other known musculoskeletal problems).
- •Skin condition apparent on the ventral UE such that might place participant at risk of irritation in the context of repeated physical contact (such as that associated with the intervention).
结局指标
主要结局
Fugl-Meyer Assessment- Upper Extremity (FM-UE)
时间窗: Change between scores from baseline (0-1month post stroke) to 3months post stroke and 6months post stroke
Upper limb (UL) impairment-based measure: The FM-UE assesses UL impairment in terms of synergistic motor control. It has 3 categories, comprised of 22 sub questions scored on a 3-point ordinal scale (0=unable, 1=partial, 2=near normal). The sum of the categories ranges between 0 and 66 points (66 = normal function). The FM-UE has shown excellent inter-rater reliability (Sullivan et al., 2011)(Duncan, Goldstein, Matchar, Divine, \& Feussner, 1992) moderate to good responsiveness (Lundquist \& Maribo, 2017) and good concurrent validity when compared with similar tests of arm motor functioning.
次要结局
- Action Research Arm Test (ARAT)(Change between scores from baseline (0-1month post stroke) to 3months post stroke and 6months post stroke)