A Feasibility Study of a Computerised Spatial Inattention Grasping Home-based Therapy for Stroke Survivors (c-SIGHT)
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Time required to collect and analyze data
研究概览
简要总结
Spatial neglect is a common post-stroke condition in which people may not be aware of anything on one side of the world (usually the same side they lost their movement). Currently, there is no effective treatment for spatial neglect. A therapy called SIGHT (Spatial Inattention Grasping Home-based Therapy) has shown early evidence of improving stroke survivors' spatial neglect (Rossit et al., 2019). SIGHT involves individuals picking-up and balance wooden rods with their less affected hand, independently, without the need for a therapist present at all times. Working with stroke survivors, carers and clinicians we have developed of a computerized version of SIGHT (c-SIGHT; Morse et al., in press). The present trial aims to: 1) investigate the feasibility of a blinded randomized controlled trial of c-SIGHT (active intervention) vs. an attentional control training version of c-SIGHT (sham intervention) in the homes of stroke survivors with spatial neglect; 2) Explore participant's experience using c-SIGHT independently at home; and 3) Explore the potential effects and effect size of c-SIGHT active intervention compared to the attentional control training to inform a future Phase II trial.
详细描述
This is a multi-centre, two-arm blinded feasibility clinical trial with an embedded qualitative study. Following baseline assessment, participants will be randomized (using minimization) to either: active vs. sham version of computerised Spatial Inattention Grasping Home-based Therapy (c-SIGHT). Randomization and group allocation will be managed and run by Norwich Clinical Trials Unit (independent from research team and outcome assessors). Participants, carers, outcome assessors, clinical care team and research team will be blinded to participant group allocation. Participants allocated to the active intervention c-SIGHT group will be required to lift and balance three wooden rods of different lengths. Those in the attentional control c-SIGHT group will use the same equipment, but will be required to lift the rods from one end only and not attempt to balance them (an attentional control). During the first training session a therapist (independent from the outcome assessors) will set-up the equipment and train the participant to self-administer the relevant version of c-SIGHT independently (i.e., without the presence of a therapist). Following this training session, participants will self-administer the training for 10 consecutive days (thirty-minute sessions 2 times a day - 'Training phase'). On the last day of the training (day 10) the therapist will return to participant's homes to complete a monitoring visit and collect equipment. To monitor adherence and therapy compliance the therapist will collect photos and videos of the first and last session of the training. A blinded assessor will collect outcome assessments at the end of the training phase (T1) and at one-month post-training (T2). The post-training (T1) data collection visit will also include one-to-one semi-structured interviews with stroke survivor participants and their carers (qualitative study).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The outcome assessor, stroke survivor, carer, research team and clinical care staff (e.g. GP) will be blinded to group allocation. Participants will not be told if they are in the active or attentional control c-SIGHT group. The set-up and equipment is the same between the two arms and only the instructions differ.
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
- •Stroke survivors meeting all of the following criteria (and none of the
排除标准
- •) at screening will be eligible to take part:.
- •18 years and older
- •At least one-week post-stroke
- •Stroke confirmed using clinical neuroimaging (head CT or MRI)
- •Medically stable (as confirmed by the stroke service medical team responsible for the individual's stroke care)
- •Capacity to give informed consent (as confirmed by the stroke service medical team responsible for the individual's stroke care and/or PI)
- •Able to follow and execute a two-step command (e.g. "lift and balance this pen/pencil")
- •Live within 70 miles of the University of East Anglia
- •Signs of spatial neglect either via clinical assessment (e.g. star cancellation test; BIT) or observation
- •Exclusion criteria:
- •History of other neurological conditions (e.g. dementia, brain tumour, Parkinson's disease, previous strokes)
- •Bilateral impairment in arms (unable to move both arms)
- •Taking part in a stroke rehabilitation research trial (which includes an intervention)
- •Carers must meet all the inclusion criteria to take part:
- •18 years and older
- •Capacity to give informed consent
- •Carer of stroke survivor in trial
- •Live within 70 miles of the University of East Anglia
研究组 & 干预措施
c-SIGHT intervention
Grasp, lift and balance three wooden rods of different lengths.
干预措施: c-SIGHT intervention (Behavioral)
c-SIGHT attentional control
Grasp and lift three wooden rods of different lengths from one end only (no attempt to balance rods).
干预措施: c-SIGHT attentional control (Behavioral)
结局指标
主要结局
Time required to collect and analyze data
时间窗: Through study completion, approximately 2 years
Time required for data collection and analysis will be computed per participant.
Recruitment rate
时间窗: Through study completion, approximately 2 years
Rate of participants recruited into the trial amongst all participants screened
Exclusion rate
时间窗: Through study completion, approximately 2 years
Rate of participants excluded from participating amongst all participants screened
Attrition rate
时间窗: Through study completion, approximately 2 years
Rate of participants and data lost
Blinding and allocation success
时间窗: Through study completion, approximately 2 years
Evaluated by the frequency of unblinding occurred among stroke survivors, carers and outcome assessors and clinical care team. Success of allocation method using minimisation will be evaluated by measuring homogeneity of the two groups on co-variates such as age, time since stroke, hemisphere damage and neglect severity.
Follow-up rate
时间窗: Through study completion, approximately 2 years
Rate of participants included at follow-up
c-SIGHT compliance
时间窗: 10 days
Measured using short videos of participants carrying out first and final session of c-SIGHT. Following the participant's completion of the trial, videos will be reviewed by the research team to monitor whether participants and therapists deviated from instructions. Photo of set-up of first and last day of the training phase will also be checked to confirm set-up of equipment was correct and constant throughout the training phase.
Adherence to c-SIGHT protocol
时间窗: Through study completion, approximately 2 years
The number of trials performed and length will be computed per session via a motion-tracking sensor.
次要结局
- Modified Caregiver Strain Index(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- Line bisection test(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- Computerised Extrapersonal Neglect Test (CENT)(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- Star cancellation test(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- One item extended test(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- Hand laterality task(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- Body drawing task(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- Oxford Cognitive Screen(Baseline (T0, before intervention))
- Stroke Impact Scale (SIS)(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- Spatial neglect visual analogue scale(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- Rates of clinical brain scans obtained(Through study completion, approximately 2 years)
- Broken Hearts test(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- System Usability Scale(Post-training (T1, after 10 days of intervention))
- 1:1 semi-structured interview(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
- Catherine Bergego Scale (CBS) carer version(Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training))
研究者
Stephanie Rossit
Lecturer
University of East Anglia