Innovative Physiotherapy in Stroke Rehabilitation During the Subacute Stage - a Prospective Randomized Single Blinded Controlled Trial and a Qualitative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ActiGraph WgtX-BT
研究概览
简要总结
The current study has the potential to improve rehabilitation during the subacute phase of a stroke, aiming to reduce the individual's disabilities and risk of falling, enhance health promoting physical activity and independence in ADL.
详细描述
The purpose of the RCT is to investigate the effects of an innovative physiotherapy intervention, called I-CoreDIST when applied in comprehensive rehabilitation after discharge from a stroke unit and throughout the rehabilitation chain.The project investigate: 1) effects on postural control and balance in various positions and functional activities. Effects on and level of physical activity, and 2) user's identifications of positive and negative features in content and coordination of physiotherapy integrated in post stroke rehabilitation. Function parameters of balance, gait and levels of physical activity at baseline and at 12 weeks will be compared to those obtained from the standard care group. Semistructured interviews will be conducted to identify patients' perceptions of key positive and negative features of content and coordination of I-CoreDIST and standard care rehabilitation after a stroke.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A stroke diagnosis
- •Can sit for 10 seconds without support
- •Age 18-85
- •Trunk Impairment Scale-Norwegian version (TIS-NV) < 15
- •Pre-stroke modified Ranking Scale (mRS) 0-3
排除标准
- •Unable to cooperate in physiotherapy
- •On-going substance abuse
- •Severe co-morbidity preventing rehabilitation, severe neurological diseases such as Parkinson disease, Multiple Sclerosis and brain tumor.
研究组 & 干预措施
ICoreDIST
The intervention starts with an assessment by the physiotherapist to identify the patient's movement problems in order to choose among the 48 exercises in the intervention. Each session lasts for 60 minutes + exercises 5-10 minutes outside of therapy and is performed 5-6 days/per week in the rehabilitation units, and 3 sessions/week + home exercises 30 minutes 3 days per week in home based or outpatient treatment during the 12 weeks period.To allow for individualisation, each exercise contains five levels of difficulty. All exercises demand enhancement of dynamic trunk stability and functional movements.
干预措施: ICoreDIST (Procedure)
Standard Care
Consists of standard inpatient rehabilitation, home-based and outpatient-based physiotherapy with the same dose as the intervention group.
干预措施: Standard Care (Procedure)
结局指标
主要结局
ActiGraph WgtX-BT
时间窗: 13 weeks
Accelerometer recording levels of physical activity and number of steps
Trunk Impairment Scale Norwegian Version
时间窗: 12 weeks
Validated scale to assess dynamic sitting balance. The test consists of ordinal 6 sub scales summed to measure dynamic sitting balance and trunk coordination.The scale ranges from 0-16 points where higher score indicates better sitting balance
次要结局
- Swedish Postural Assessment Scale For Stroke Norwegian Version(12 weeks)
- MiniBESTest(12 weeks)
- Bodyfitter seat sensor system(12 weeks)
- Amti Force Platform(12 weeks)
- 10 meter walk test(12 weeks)
- 2 minute walk test(12 weeks)
- EQ-5D-3L(12 weeks)
- Stroke Specific Quality of Life Scale(1 day)