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临床试验/NCT03683160
NCT03683160已完成不适用

A Cognitive-Augmented Mobility Program (CAMP): Combining Cognitive Strategy Training And Best Evidence Mobility Training To Optimize Long-Term Meaningful Living For People With Stroke

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年3月1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
10
试验地点
1
主要终点
Mean Canadian Occupational Performance Measure scores

研究概览

简要总结

This project will combine best-evidence gait and mobility training with best evidence cognitive strategy training to produce a new cognitive-augmented mobility intervention that is expected to optimize long-term functional mobility outcomes for those living with stroke. More importantly, the new cognitive-augmented mobility program (CAMP) will address two crucial outcomes that do not occur with current approaches: 1. Maintenance of mobility gains after discharge from formal rehabilitation and 2. Transfer of skills learned in rehabilitation to real-world community living. This project will result in a new, fully defined intervention, and will provide effect size and cost estimates to design a future appropriately powered randomized controlled trial (RCT).

详细描述

Difficulty walking is a leading cause of activity restriction in survivors of stroke. It is directly related to important functional issues, such as challenges in crossing a street in time, difficulty walking to a bus stop and increased risk of falls. These functional issues can then impact a person's confidence to move around their community, ultimately leading to lower levels of physical activity and potential negative health consequences. The best way to optimize recovery in walking and mobility is not yet known, and there are critical gaps in existing treatments. While some approaches are effective in the short term, strategies to promote the maintenance of improvements are not well established, benefits are usually not transferred beyond the specific skills trained and the specific context in which they were learned, few interventions impact community participation, and cost effectiveness has rarely been investigated. A potential solution exists in combining best-evidence interventions: task-specific gait and mobility training to improve skill quality, cardiorespiratory and strength exercises to improve endurance and speed, and cognitive strategy training to teach problem solving, improve confidence and to ensure long-term maintenance and transfer of skills to home and community settings. The investigators will combine best evidence mobility interventions with best evidence cognitive strategy training to develop and evaluate a new intervention to optimize long-term functional mobility outcomes for those living with stroke. The project consists of two sequential stages: 1) intervention development through literature synthesis; face validity testing using focus groups with patients, family members and expert stroke rehabilitation clinicians; and intervention refinement; followed by 2) feasibility/pilot testing with 10 people more than 6 months post stroke. Anticipated outcomes include a fully developed intervention with the potential to optimize mobility rehabilitation and effect size estimates to permit the design of a future, appropriately-powered randomized controlled trial.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients aged 18 years of age or older
  • •post stroke
  • •have completed outpatient therapy
  • •can walk a minimum of 3 metres with or without an aid

排除标准

  • •patient does not a mobility goal
  • •neurological diagnoses other than stroke
  • •major psychiatric illness
  • •significant dementia (MoCA scores < 21)

研究组 & 干预措施

Cognitive Augmented Mobility Program

Experimental

CAMP will combine education, one-on-one cognitive strategy training, and a cardiovascular and strength-training program conducted within a group setting. It will be run as a group of up to 6 participants, facilitated by a physiotherapist and a physiotherapy assistant or kinesiologist. It consists of 2 phases with a total of 19 sessions: Intervention Preparation (3 sessions), Active Intervention (16 sessions), and Follow-Up (1 session).

干预措施: Cognitive Augmented Mobility Program (Other)

结局指标

主要结局

Mean Canadian Occupational Performance Measure scores

时间窗: 1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention

The Canadian Occupational Performance Measure (COPM) is a self-report measure of performance and satisfaction with self-selected goals. Participants are asked to generate 5 personally meaningful rehabilitation goals and rate their current performance and satisfaction on a scale from 1 to 10. Total scores are the average performance and satisfaction score. Higher scores indicate better outcomes.

次要结局

  • Mean 5 metre walk test scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean Activity-specific Balance Confidence Scale scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean Stroke Impact Scale scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean Community Balance and Mobility Scale scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean Functional Independence Measure scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean 6-minute walk test scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)
  • Mean Berg Balance Scale scores(1) 1 week pre-intervention; 2) 1 week post-intervention, 3) 4 to 5 weeks post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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