Effects of Mental Practice for Mobility in Post-stroke Hemiparesis: Randomized Controlled Trial of Efficacy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Timed Up and Go (TUG)
研究概览
简要总结
Stroke is a neurovascular event characterized by impaired blood supply to the brain due to rupture or obstruction of certain cerebral arteries, which often results in hemiparesis and can affect individuals of any age and sex, being prevalent in the elderly population.
Among the main treatments available for stroke rehabilitation, most of them demands an appropriate structure and high-qualified personnel. Searching for more affordable treatment options, several studies suggest the use of mental practice with motor imagery as a potential therapeutic tool, since it can be performed at any place or any time the patient wishes, including their own homes.
Motor imagery can be defined as the covert cognitive process of imagining a movement of your own body(-part) without actually moving that body(-part).
Within this context, the objective of this study is to investigate the effects of mental practice for mobility, gait function and speed and muscle strength of the lower limb in subacute post-stroke hemiparesis.
详细描述
Post-stroke patients will be invited to participate after hospital discharge, based on inclusion and exclusion criteria. Then, after acceptance, participants will be randomized (block strategy) into two groups: Control group (Physiotherapy and Cognitive mental exercise) and Intervention group (Physiotherapy and Mental Practice group).
At baseline, 4 weeks (end of intervention) and 6 weeks, participants will be evaluated through the following tests: Timed-Up and Go test, 5-Meter Walk Test, TUG-ABS, WHOQOL-Bref, DASS-21 and muscle strength.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 73 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemiparesis after ischemic stroke (15 to 180 days after the event);
- •only one cerebral hemisphere affected;
- •no chemical, alcohol or drug dependency;
- •Score average ≥ 2,5 point in the instrument "Visual and Kinesthetic Imagery Questionnaire" (KIVQ-10);
- •No cognitive impairment (18 points in the Mini-Mental State Examination - 0-4 years of educations and 24 points (>4 years of education);
- •Not participating in any other type of physiotherapy or physical activity during the study period;
- •Complaining of difficulty in gait and mobility after stroke;
- •Able to stand up from a chair and walk some distance with or without auxiliary device;
排除标准
- •Hemorrhagic or ischemic progressing to hemorrhagic stroke;
- •Score ≥ 4 on the Visual Analogue Pain Scale;
- •Score ≥ 2 on the modificator Ashworth scale;
- •Visual disabilities;
- •Severe Aphasia;
- •Cardiovascular instability and/or other neurological disorders that may impair the mobility and gait.
结局指标
主要结局
Change in Timed Up and Go (TUG)
时间窗: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
This is a measure that examines the participant's basic mobility skills by measuring seconds to rise from sitting, walk 3 meters, return, and sitting down
5-Meter Walk Test
时间窗: 1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
This is a measure that examines the participant's gait speed (cut off 6 seconds)
次要结局
- Change in Quality of life(1 week before intervention; 4 weeks after intervention; 6 weeks after intervention)
- Change in Muscle strength(1 week before intervention; 4 weeks after intervention; 6 weeks after intervention)
- Change in Mental health(1 week before intervention; 4 weeks after intervention; 6 weeks after intervention)
- Change in TUG-ABS(1 week before intervention; 4 weeks after intervention; 6 weeks after intervention)
研究者
Zaqueline F. Guerra
MSc
Federal University of Juiz de Fora