Effectiveness of Additional Trunk Exercises on Gait Performance: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- The change in Tinetti Performance Oriented Mobility Assessment
研究概览
简要总结
The aim of SWEAT² study is to further explore the effects of additional customized trunk exercises on clinical and biomechanical gait performance. Despite of the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. The findings of this study might lead to new scientific insights in the importance of the trunk during gait rehabilitation in people suffering from stroke submitted to a rehabilitation hospital.
详细描述
Objective: To examine the effects of additional trunk exercises on gait performance via clinical and biomechanical assessments in patients receiving inpatient rehabilitation after stroke.
Design: The design of this study is an assessor-blinded randomized controlled trial. Prior to evaluation, participants will be randomly allocated to either the experimental or control group by means of concealed envelopes. The number of patients required for this study was calculated a priori to ensure sufficient statistical power. Analysis showed that a sample size of 30 patients in each group was necessary to detect a difference (ES1) with 80 % using a two-tailed hypothesis (with significance of p=0.05).
Intervention: All patients will receive a multidisciplinary conventional stroke rehabilitation program provided by the rehabilitation staff. The control group will receive a series of cognitive exercises focusing on aspects of memory (visual, auditory, and working memory), attention (sustained attention and selective attention), and executive functioning (planning and problem-solving). The additional training of the trunk training group focuses on trunk muscle strength, coordination and selective movements. The training program will consist of task-specific movements of the upper and lower part of the trunk both in supine and sitting position on stable and unstable surfaces (physio balls). The following trunk exercises will be performed: bridging, reaching, lower/upper trunk rotations, lower/upper trunk lateral flexion, upper/lower trunk flexion, ...
Outcome measures:
- Tinetti Test
- Gait parameters recorded during 3D-Full body gait analysis:
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
- Single (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
- •Haemorrhagic or ischaemic stroke diagnosis has to be confirmed by the consultant appointed at the rehabilitation centre on the basis of CT or MRI imaging
- •Patients with a history of first stroke
- •Stroke onset within five months
- •Patients who are able to sit independently for 30 seconds on a stable surface
- •Hospitalized in the rehabilitation hospital RevArte
- •Written informed consent
排除标准
- •A score of 20 or higher on the Trunk Impairment Scale
- •A score of 2 or lower on the Functional Ambulation Categories
- •Patients suffering from other neurological and orthopaedic disorders that could influence motor performance and balance
- •Patients not able to understand instructions
研究组 & 干预措施
Trunk training
Exercises: Core stability training
干预措施: Trunk training (Other)
Cognitive exercises
Exercises: The RevArte Visual Search Test (RVST) of Lafosse et al (2013) and the Visuospatial Neglect Test Battery (VNTB) of Vaes et al. (2015)
干预措施: Cognitive exercises (Other)
结局指标
主要结局
The change in Tinetti Performance Oriented Mobility Assessment
时间窗: week 0, week 5, and week 9
Tinetti Test measures gait and balance on a 3-point ordinal scale ranging from 0 to 2. The maximum score of the total Tinetti is 28 points, whereby a maximum of 12 and 16 points can be obtained for gait and balance subscales.
次要结局
- The change in temporal gait parameters(week 0, week 5, and week 9)
- The change is muscle activity of the trunk and lower legs during walking(week 0, week 5, and week 9)
- The change in kinematic parameters of the trunk, hip, knee, and ankle(week 0, week 5, and week 9)
研究者
Tamaya Van Criekinge
Academic assistent
Universiteit Antwerpen