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临床试验/NCT03195738
NCT03195738已完成不适用

Feasibility and Effects of the CO-OP Approach for Post-concussion Rehabilitation

Holland Bloorview Kids Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
Change in Occupational Performance and Satisfaction (Canadian Occupational Performance Measure)

研究概览

简要总结

The purpose of this study is to evaluate the feasibility and effects of a cognitive intervention for youth following concussion

详细描述

Concussion, a form of mild traumatic brain injury, is one of the most commonly reported injuries in youth. While most recover quickly, a substantial subset (30-58.5%) report symptoms that persist at one month with a reported 11-14% who continue to report symptoms beyond three months. Currently, there are no evidence-based guidelines for treatment that address occupational (meaningful activity) concerns for youth who are slower to recover post-concussion. It is postulated that a top-down rehabilitation approach with metacognitive strategy training as the core of the intervention might be effective.The Cognitive Orientation to Occupational Performance (CO-OP) Approach is a metacognitive strategy training approach with a growing body of literature supporting it's value in improving participation in meaningful activity and achieving self-selected occupation-based goals for adults with brain injury and youth with moderate to severe brain injury.Given the long-term occupational concerns in youth with persistent post-concussion symptoms, and the lack of evidence based interventions for these youth, it is hypothesized that the CO-OP Approach may facilitate return to meaningful occupation in this population.

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
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • concussion diagnosed by a physician;
  • presence of at least one post-concussion symptom for three months or more; -experiencing challenges with usual daily activities secondary to post-concussive symptoms;
  • able to identify four or more occupation-based goals;
  • 12-18 years of age;
  • no concurrent serious medical or psychiatric diagnoses.
  • has a parent who can support participation and participate in a post intervention interview

排除标准

  • non English speaking

结局指标

主要结局

Change in Occupational Performance and Satisfaction (Canadian Occupational Performance Measure)

时间窗: Measure will be administered at baseline, within one week post intervention (i.e. at 8 weeks) and again at 3 month follow up.

A change score of two points is considered clinically significant (McColl, Carswell, Law, Pollock, Baptiste, \& Polatajko 2006). During a semi-structured interview, clients are asked to identify a minimum of five occupational performance issues (OPI's). The five most important OPI's as determined by the client are identified using a ranking scale (1=not important at all to 10=extremely important) and then ranked according to performance and satisfaction with performance using 10 point scales (Performance score of 1=not able to do it to 10=able to do it extremely well; Satisfaction score of 1=not at all satisfied to 10=extremely satisfied).

次要结局

  • Change in symptoms (Post Concussion Symptom Inventory)(Measure will be administered at baseline, within one week post intervention (i.e. at 8 weeks) and again at 3 month follow up.)
  • Change in mood and self-concept (Beck Youth Inventories)(Measure will be administered at baseline, within one week post intervention (i.e. at 8 weeks) and again at 3 month follow up.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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