The Impact of High-intensity, Task Specific Training Combined With Environmental Enrichment for Individuals in a Late Phase After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in Modified Motor Assessment Scale score according to Uppsala from baseline to after intervention/control and from baseline to 6 months follow up.
研究概览
简要总结
We designed an explorative clinical study to assess the effectiveness of an enriched intense and task-oriented therapy program in enhancing motor recovery in patients with moderate to moderately severe hemiplegia after stroke. This enriched comprehensive task-specific therapy (ETT) program combines intensive and task-specific therapy with the sensory-motor, social, and cognitive stimulation inherent to environmental enrichment. We also investigated whether ETT improves gait, balance, upper and lower limb function, and confidence in task performance, health-related quality of life (HRQoL) and reduces fatigue and depression.
详细描述
Background The brain has a limited ability for repair. However, in recent years it became evident that a remarkable, yet restricted ability for regeneration of neuronal connections exists, with positive implications for the rehabilitation of individuals with stroke. Several studies have shown that stroke-lesioned animals, which are exposed to a so called enriched environment (large cages, group housing of animals, equipped with toys and with possibilities for physical activity and social interactions) show signs of tissue regeneration/plasticity in the brain. Research has shown that rats exposed to this enriched environment are recovering significantly faster from stroke than rats in standard cages, despite the fact that the total tissue loss between the rats did not differ.
Recovery and improvement of motor functions and skills after stroke depend on spontaneous repair processes but also on the reorganization of neural mechanisms by stimuli and demands that are placed on the motor control system. In spite of numerous research studies showing that functional recovery after stroke is possible even many years after the stroke onset, it is unusual for stroke victims to be offered any kind of rehabilitation during later stages.
The combination of modalities in multimodal interventions is thus expected to have a synergistic effect on neuroplasticity in rehabilitation after stroke in humans. In a recent clinical trial, multimodal interventions based on rhythm and music or therapeutic horseback riding improved recovery in the late phase after stroke Nevertheless, novel combinational treatment approaches are needed to promote neuroplasticity and motor recovery after stroke. A priority is to translate promising basic research to clinical settings and to evaluate enriched combinational therapy programs that appear to be more effective than single interventions
A. What is the impact of high intensity task specific goal-directed training combined with environmental enrichment for individuals in a late phase of stroke? B. What are the subjects' experiences of the rehabilitation program? C. What are the biomarkers of successful stroke recovery? D. How does the intervention effect the subjects' walking ability on a detailed level? The study is a within-subject, repeated-measures design with pretest-posttest study, to assess outcomes after ETT. The intervention was preceded by a baseline period of usual care (UC) for 3 weeks, which also served as a control. The trial enrolled Swedish or Norwegian stroke survivors who had applied to a Swedish rehabilitation agency that provides rehabilitation services in Spain.
The physical evaluation was performed in Sweden prior to and after the intervention and 6 months after completion of the intervention / control period. In addition, a three-month follow-up in form of questionnaires was performed.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least six months and maximum 10 years after the onset of stroke
- •Disability grade between 2 and 4 on the Modified Rankin Scale.
- •Some degree of hemiparesis, according to the primary outcome measure M-MAS UAS -99, at baseline.
- •Approved by the referring / prescribing physician for intensive training
- •Medically stable considering cardiovascular conditions
- •Cognitive and speech ability that enables instruction, intervention and evaluation
- •Ability and willingness to travel to the place of evaluation
- •Able to perform sitting transfers independently or with manual assistance
排除标准
- •Exercise-induced epilepsy.
- •Injury, illness or addiction, making the individual unsuitable for participation.
- •Having participated in an intense comprehensive rehabilitation program (additional to post-stroke acute- and subacute rehabilitation) at some point within the past six months.
- •Scheduled for other treatment with focus on intensive training during the study.
- •Use of assistive technology for sitting transfers
研究组 & 干预措施
UC + ETT
An enriched comprehensive task-specific therapy (ETT) program combining intensive and task-specific therapy with the sensory-motor, social, and cognitive stimulation inherent to environmental enrichment.
The intervention was preceded by a baseline period of usual care (UC) for 3 weeks, which also served as a control.
干预措施: UC + ETT (Other)
结局指标
主要结局
Change in Modified Motor Assessment Scale score according to Uppsala from baseline to after intervention/control and from baseline to 6 months follow up.
时间窗: baseline, 3 weeks, 6 months
Motor function
次要结局
- Change in 10 m walk test from baseline to after intervention/control and from baseline to 6 months follow up.(baseline, 3 weeks, 6 months)
- Change in Bergs balance scale from baseline to after intervention/control and from baseline to 6 months follow up.(baseline, 3 weeks, 6 months)
- Change in Life situation among spouses after the stroke event questionnaire from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.(baseline, 3 weeks, 3 months, 6 months)
- Change in JAMAR from baseline to after intervention/control and from baseline to 6 months follow up.(baseline, 3 weeks, 6 months)
- Change in Montgomery Åsberg depression rating scale from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.(baseline, 3 weeks, 3 months, 6 months)
- Change in Nine Hole Peg Test from baseline to after intervention/control and from baseline to 6 months follow up.(baseline, 3 weeks, 6 months)
- Change in Fatigue impact scale from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.(baseline, 3 weeks, 3 months, 6 months)
- Change in Falls Efficacy scale from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.(baseline, 3 weeks, 3 months, 6 months)
- Change in levels of biomarkers in blood from baseline to after control/intervention and from baseline to 6 months after intervention.(baseline, 3 weeks, 6 months)
- Change in Six minute walking test from baseline to after intervention/control and from baseline to 6 months follow up.(baseline, 3 weeks, 6 months)
- Change in Box and Blocks test from baseline to after intervention/control and from baseline to 6 months follow up.(baseline, 3 weeks, 6 months)
- Change in Life satisfaction checklist from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.(baseline, 3 weeks, 3 months, 6 months)
- Change in EuroQual 5D from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.(baseline, 3 weeks, 3 months, 6 months)