The Feasibility of the Adapted H-GRASP Feedback Program for Perceived and Daily Life UL Activity in Patients With Good Observed But Low Perceived Activity in the Chronic Phase Post Stroke: a Pilot Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
In a recent cross-sectional study, it was shown that people with a good observed upper limb (UL) motor function but low perceived UL activity show a reduced daily-life UL activity. The investigators will now investigate the feasibility of a phone-monitored home exercise and feedback program for the UL following stroke and the preliminary effects on the perceived UL activity and actual daily-life UL activity for participants with good observed UL motor function but low perceived UL activity in the chronic phase post-stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- •First-ever unilateral, supratentorial stroke, as defined by the American Heart Association/American Stroke Association
- •Minimum six months after stroke
- •Living in the community
- •≥18 years old
- •Good observed UL motor function but low perceived UL activity. Good observed UL motor function is defined as a score >50/66 on the Fugl-Meyer Assessment-Upper Extremity (FMA-UE). Low perceived UL activity is defined as a score ≤75/100 on the hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand).
排除标准
- •Other neurological condition than stroke
- •Musculoskeletal disorder that affects UL use
- •No informed consent
- •Participation in an interventional Study with an investigational medicinal product (IMP) or device
结局指标
主要结局
Recruitment rate
时间窗: 45 days (post-intervention)
% of individuals who were eligible and agreed to participate
Retention rate
时间窗: 45 days (post-intervention)
% of participants who completed the intervention
Safety
时间窗: 45 days (post-intervention)
# of participants with increased pain while performing exercises as measured by visual analogue scale
Adherence to the intervention protocol
时间窗: 45 days (post-intervention)
% of participants who achieved 12 hours of average weekly exercise
Activity ratio
时间窗: 45 days (post-intervention)
Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL
Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)
时间窗: 45 days (post-intervention)
Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome.
次要结局
- Action Research Arm Test (ARAT)(Day 17 (baseline), 45 days (post-intervention))
- Fugl-Meyer motor assessment - upper extremity (FMA-UE)(Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention))
- Motor Activity Log - 14 Item Version Amount Of Use (MAL-14 AOU)(Day 17 (baseline), 45 days (post-intervention))
- Motor Activity Log - 14 Item Version Quality Of Movement (MAL-14 QOM)(Day 17 (baseline), 45 days (post-intervention))
- Erasmus modified Nottingham Sensory Assessment (Em-NSA)(Day 17 (baseline), 45 days (post-intervention))
- simplified modified Rankin Scale questionnaire (smRSq)(Day 17 (baseline), 45 days (post-intervention))
- Hospital Anxiety and Depression Scale (HADS)(Day 17 (baseline), 45 days (post-intervention))
- Confidence in Arm and Hand Movement Scale (CAHM)(Day 17 (baseline), 45 days (post-intervention))
- Magnitude ratio(Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention))
- Density plot(Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention))
- Visual Analogue Scale (VAS)(Day 17 (baseline), 45 days (post-intervention))
- EuroQol Five Dimensions Five Levels Questionnaire (EQ-5D-5L)(Day 17 (baseline), 45 days (post-intervention))
- Hours of UL activity(Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention))
- Bilateral magnitude(Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention))