Feasibility Study of On-Track - a Digital System for Upper Limb Rehabilitation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews
研究概览
简要总结
Feasibility study of On-Track - a digital system for upper limb rehabilitation after stroke.
Population - stroke patients over 18 years old.
详细描述
TITLE Feasibility study of On Track - a digital system for upper limb rehabilitation after stroke
DESIGN & METHODS Mixed methods
Aims Assess the feasibility of 'On-Track' (a new arm rehabilitation system), for use by patients, and therapists in stroke rehabilitation services.
OUTCOME MEASURES Various. (including functional and self-reported measures)
POPULATION Stroke survivors, their family/carers, clinicians, professionals and lay people working with stroke survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Adults (aged 18 or over).
- •Stroke diagnosis less than 6 months previously (first or recurrent). Some participants will be recruited from an in-patient rehabilitation ward, hence the 6-month poststroke limit.
- •Arm impairment of any type or level (including weakness-including dense hemiplegia, neglect and sensory deficits). This enables better understanding of which impairment level groups could benefit or not from using the intervention, especially considering the impact it may have on people's motivation regardless of their level of impairment.
- •Ability to provide informed consent.
- •Reliability to communicate (verbally or non-verbally) and understand English.
- •Ability to read a predefined short message.
排除标准
- •Unstable medical condition.
- •Self-reported 'severe' pain in the arm affected either at rest or during movement.
- •Severe oedema in the arm affected by their stroke, judged by the consenting therapist.
- •Known discharge plans to a hospital other than the recruitment site or residential care in less than 7 weeks (a small proportion of patients in in-patient rehab may be in hospital for up to 12 weeks).
- •Participants who are unable to engage with the intervention for a period of more than 7 consecutive days will be reviewed in a case-by-case basis by the members of the team responsible for delivering the intervention to determine if study continuation is appropriate.
研究组 & 干预措施
On-Track
Stroke survivors receiving the OnTrack intervention for 12 weeks consisting of arm activity tracking and self-management coaching. Assessments are done before and after the intervention.
干预措施: Feasibility of OnTrack (Device)
结局指标
主要结局
Number of Therapists Finding the OnTrack Intervention Acceptable in Semi Structured Interviews
时间窗: Week 13
To assess the feasibility of the study design and procedures. Semi structured interviews will aim to collect therapists opinions on the strengths and weaknesses of On-Track.
Number of Participants Finding the OnTrack Intervention Acceptable in Semi Structured Interviews
时间窗: Week 13
Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of OnTrack. Interviews determine whether participants found the intervention easy to use and acceptable and if it is fit for their rehabilitation needs.
次要结局
- Motor Assessment Log (MAL) - Questionnaire(Baseline, follow-up (week 7), follow-up (week 13))
- Friends and Family Test(Week 13)
- System Usability Scale (SUS)(Week 13)
- Visual Analogue Scale for Pain - Question(Baseline, follow-up (week 7), follow-up (week 13))
- Montreal Cognitive Assessment (MoCA)(Baseline, follow-up (week 7), follow-up (week 13))
- Unilateral Spatial Neglect (USN) (Aka Albert's Test)(Baseline, follow-up (week 7), follow-up (week 13))
- EQ 5D 5L (Health Related Quality of Life)(Baseline, week 7, week 13)
- Modified Rankin Scale(Baseline, follow-up (week 7), follow-up (week 13))
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE)(Baseline, follow-up (week 7), follow-up (week 13))
- Patient Activation and Motivation (PAM) - Questionnaire 10 Short Questions(Baseline, follow-up (week 7), follow-up (week 13))