SENSory Re-learning of the UPPer Limb After Stroke (SENSUPP): a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in Tactile object identification test from baseline to post intervention and from baseline to 3 month follow-up.
研究概览
简要总结
The overall aim of this study is to investigate if sensory re-learning in combination with task-specific training is more effective than task-specific training alone to improve sensory function of the hand, dexterity, the ability to use the hand in daily activities, perceived participation and life satisfaction.
详细描述
More than half of stroke survivors suffer from sensory impairments of their affected upper limb (UL), which can lead to long term problems to use the UL in daily life, such as personal care, household- and leisure activities. Few studies have evaluated if sensory re-learning in combination with task-specific training can improve the ability to perform daily hand activities and perceived participation. Therefore, there is a need for more studies. This is a single-blinded pilot randomized controlled trial with two treatment arms. Thirty persons with sensory impairments of the UL after stroke will be recruited and randomized to either sensory re-learning in combination with task-specific training or to task-specific training only. The training will consist of 2.5 hours of group training per session, 2 times per week for 5 weeks. Assessments will be conducted pre- and post-training and at 3 months' after the intervention.
Descriptive statistics (mean (SD) or median (min- max) will be used to characterize the study groups. Non-parametric statistics will be used for ordinal data and parametric statistics for continues data. To analyze between group differences, the Mann-Whitney test or Independent sample t-test will be used and Wilcoxon signed ranks test or paired t-test to analyze within group differences. The level of statistical significance will be set at p < 0.05.
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)
盲法说明
The assessors are blinded to the participants' group allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sensory impairments (≤5 points in Shape-Texture Identification test) of upper limb after stroke
- •ability to grasp and release an object
- •be able to understand oral and written information
- •18-80 years of age
- •at least 6 months since stroke onset
- •be able to walk with or without an assistive device
排除标准
- •sensory impairments of the UL due to other diagnosis than stroke
研究组 & 干预措施
Sensory group
Sensory re-learning in combination with task-specific training
干预措施: Sensory group (Behavioral)
Control group
Traditional task-specific training
干预措施: Control group (Other)
结局指标
主要结局
Change in Tactile object identification test from baseline to post intervention and from baseline to 3 month follow-up.
时间窗: Baseline, 5 weeks, 3 months.
Measures the ability to identify different objects without vision. Out of 20 objects, 15 are used during the assessment. Within 15 seconds the participant should blind-fold recognize an object. Correct answer yields 2 points, recognition of some feature of the object yields 1 point and incorrect answer 0 points; thus a maximum total sum score of 30 points.
Change in Fugl- Meyer Assessment (FMA-UE) sensory section from baseline to post intervention and from baseline to 3 month follow-up.
时间窗: Baseline, 5 weeks, 3 months.
Measures light touch and proprioception of the upper limb after stroke. The score ranges from 0 to 4 points for each subtest with a maximum score of 8 points per hand.
Change in Semmes- Weinstein monofilament (SWM) test from baseline to post intervention and from baseline to 3 month follow-up.
时间窗: Baseline, 5 weeks, 3 months.
Assess touch detection thresholds of the hand and fingers. The short version with 5 filaments from 0.07 gram to 279 grams will be used. The touch detection thresholds are scored on a 0 to 5-point scale, where 5 represents the thinnest filament and 0 represents the largest filament. Five different positions of the hand are tested: fingertip on digit I, II, V and on the thenar and hypothenar region. Both hands are tested and the total sum score is 25 for each hand.
Change in Shape- Texture Identification test (STI) from baseline to post intervention and from baseline to 3 month follow-up.
时间窗: Baseline, 5 weeks, 3 months.
Measures the ability to identify shapes and textures. Both the affected and non- affected hand are tested and the scores range from 0 to 3 points per hand for each subtest with a maximum score of 6 points.
次要结局
- Change in Modified Motor Assessment Scale (M-MAS) for the upper limb from baseline to post intervention and from baseline to 3 month follow-up..(Baseline, 5 weeks, 3 month.)
- Change in Mini Sollerman Hand Function Test (mSHFT) from baseline to post intervention and from baseline to 3 month follow-up.(Baseline, 5 weeks, 3 month.)
- Change in Box and Block Test (BBT) from baseline to post intervention and from baseline to 3 month follow-up.(Baseline, 5 weeks, 3 month.)
- Change in Grippit from baseline to post intervention and from baseline to 3 month follow-up.(Baseline, 5 weeks, 3 month.)
- Changes in Motor Activity Log (MAL) from baseline to post intervention and from baseline to 3 month follow-up.(Baseline, 5 weeks, 3 month.)
- change in Stroke Impact Scale, (SIS) Participation domain from baseline to post intervention and from baseline to 3 month follow-up.(Baseline, 5 weeks, 3 month.)
- Change in Life Satisfaction Scale (LiSat) from baseline to post intervention and from baseline to 3 month follow-up.(Baseline, 5 weeks, 3 month.)
- Change in Canadian Occupational Performance Measure (COPM) from baseline to post intervention and from baseline to 3 month follow-up.(Baseline, 5 weeks, 3 month.)
研究者
Christina Brogardh
Professor
Lund University