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临床试验/NCT04696302
NCT04696302已完成不适用

Focus of Attention Effects on Motor Performance and Learning in Individuals Post Stroke During Seated Lateral Weight Shifting: A Two-phase Feasibility Study

Western Carolina University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年3月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Recruitment

研究概览

简要总结

This two phase feasibility study looked at the feasibility of conducting a clinical trial in the outpatient and inpatient rehab setting exploring how individuals post stroke respond to different focus of attention cues. Focus of attention refers to whether individuals in are thinking about how their body is moving, internal focus, or on the effect their body has on the environment, external focus, during motor task. This trial will specifically look at the effect focus of attention has on motor performance and learning in individuals post stroke during lateral seated weight shifting task.

详细描述

This was a two phase feasibility study exploring appropriate management, setting, participants including inclusion and exclusion criteria, attrition rates, protocol, and retention. Outcome data for each stage were collected during baseline, acquisition, short-term, and long-term retention.

There were two primary objectives of this two phase feasibility study. The first was to uncover some potential short comings in research designs used in this area. The second was to explore the feasibility of a study in both the chronic and acute stroke populations in a rural community. Topics of feasibility include recruitment, retention, and specific inclusion and exclusion criteria. Extending the work by Muckel and Merholz, this feasibility study examined performance of individuals post stroke during a seated lateral weight shifting task and incorporated retention trials, quality of movement exploration, and bilateral weight shifting.

During Phase I, individuals in both groups sat unsupported on a hi-lo mat table which was adjusted so participants were sitting at 90 degrees hip and knee flexion with feet shoulder width apart. Tape marks were used to mark initial set up ensuring standardized positioning for each trial. Following baseline trials, all participants watched the same instructional video describing lateral weight shifting. The instructions included correct mechanics that should be used when weight shifting laterally with focus on correct form needed for the movement.

Testing included baseline, acquisition, short term retention (5 minutes later), and long-term retention (7-10 days later). Participants performed three trials of seated weight shifting to each side at all timepoints. During acquisition, the internal focus group was instructed to "shift your weight as much as possible towards your right or left hip without using your arms". The external focus group sat with targets one arm length away at shoulder height and were instructed to "shift your body weight as much as possible towards the blue/orange target without using your arms." During baseline and retention trials, adults were instructed to "lean as far as you can to the right/left without using your arms." During Phase II, the protocol was similar except 6 trials were performed for acquisition to potentially improve motor learning, which was not significant in Phase I per retention data. Other changes to the protocol included allowing participants to move their feet when weight-shifting. Instructions were also revised. The external focus group was told to "move your shoulder as close to the blue/orange target as possible", while the internal focus group was told to "shift your body weight as much as possible towards your right/left hip without using your arms."

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)

盲法说明

Participants were blinded from whether they were in control or experimental group and statistician was blinded.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •participants with history of stroke
  • •ability to sit statically without physical assistance

排除标准

  • •severe hemineglect (star cancellation test <44/54)
  • •inability to follow multistep commands
  • •orthopedic issues that limited their ability to weight shift including severe hip or back pain
  • •individuals with other neurologic conditions such as dementia
  • •individuals with contraversive pushing.
  • •During the first arm (phase) of the study there were age matched healthy controls.

研究组 & 干预措施

Focus of attention in individuals post chronic stroke during seated lateral weight shifting

Experimental

Feasibility study

干预措施: Focus of attention (Behavioral)

Focus of attention in individuals post acute stroke during seated lateral weight shifting

Experimental

Feasibility study

干预措施: Focus of attention (Behavioral)

结局指标

主要结局

Recruitment

时间窗: One year for each arm of the study.

Percentage of participants recruited out of the estimated number needed by power analysis. Power analyses revealed 42 participants were needed for 2X4 mixed model ANOVA 193 analysis, a=.05, power=.8, with a medium effect size, f=.2.

Retention

时间窗: One year for each arm of the study.

Percentage of participants that completed all 4 timepoints, baseline, acquisition, short term, and long term retention out of those that completed baseline trials.

次要结局

  • Seated lateral excursion during baseline to affected side(baseline (prior to training))
  • Shoulder alignment during long term retention to unaffected side(long-term (7 days after training))
  • Shoulder alignment during baseline to affected side(baseline (prior to training))
  • Shoulder alignment during short term retention to affected side(short-term (5 minutes after training))
  • Shoulder alignment during baseline to unaffected side(baseline (prior to training))
  • Shoulder alignment during acquisition or training to unaffected side(acquisition (30 minutes) through study completion, average of one year.)
  • Shoulder alignment during acquisition or training to affected side(acquisition (30 minutes) through study completion, average of one year.)
  • Shoulder alignment during short term retention to unaffected side(short-term (5 minutes after training))
  • Seated lateral excursion during acquisition or training to affected side(acquisition (30 minutes) through study completion, average of one year.)
  • Shoulder alignment during long term retention to affected side(long-term (7 days after training))
  • Seated lateral excursion during baseline to unaffected side(baseline (prior to training))
  • Seated lateral excursion during acquisition or training to unaffected side(acquisition (30 minutes) through study completion, average of one year.)
  • Seated lateral excursion during short-term retention to affected side(short-term (5 minutes after training))
  • Seated lateral excursion during short-term retention to unaffected side(short-term (5 minutes after training))
  • Seated lateral excursion during long-term retention to unaffected side(long-term (7 days after training))
  • Seated lateral excursion during long-term retention to affected side(long-term (7 days after training))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashley Hyatt

Assistant Professor of Physical Therapy

Western Carolina University

研究点 (1)

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