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临床试验/NCT03357042
NCT03357042撤回不适用

A Multi-modal Evaluation of a Physical Intervention Approach to Treating Post-Concussive Symptoms

Lakehead University2 个研究点 分布在 1 个国家开始时间: 2018年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Brain-derived neurotropic factor

研究概览

简要总结

A concussion occurs when a person receives an impact to the head. The most common persistent symptoms that generate from a concussion are headaches, depression, lack of balance and dizziness. One recommendation to alleviate persistent symptoms of concussion is rest. Research findings indicate that the benefit of rest is inconclusive to help individuals suffering from a concussion return to activities of daily living. One treatment approach in reducing concussion symptoms is physical exercise therapy. Research findings, however, are limited to treatments being administered before the symptoms are considered persistent. Based on this rationale, the aim of this study is to examine the effect of a physical therapy intervention in minimizing persistent symptoms of concussion using measures of cognition and brain function, mental and physical health, and driving performance. If successful, this physical therapy intervention may help treat persistent concussion symptoms, improving the quality of life and ability for individuals to function normally in their daily lives, and resulting in savings to the healthcare system

详细描述

Recruitment will include the use of posters, social media, and word of mouth. Posters designed to recruit healthy individuals free of a concussion will be displayed around Lakehead University, as well as various public spaces in Thunder Bay. Separate posters (attached) will also be used to recruit persons who have sustained a concussion in the previous two weeks to six months and are still experiencing symptoms (Persistent Post-concussive symptoms; PCS). These posters will be displayed at Fairway Physiotherapy and healthcare clinics around Thunder Bay. All posters will be shared on Lakehead University School of Kinesiology social media pages.

Prior to participating in the study, all participants will have a medical examination with Dr. Wark at least two weeks following the initial injury. If the potential participant expresses interest in the study, his/her information will be passed along to a member of the research team. A member of the research team will contact the potential participant to schedule pre intervention assessments based on the participant's, research team, and lab availability. Participants will also be provided with a copy of the information letter at this time. Any medical screening tools will be kept by Dr. Wark as part of the patient's medical records, regardless of eligibility for the study. Any information taken from these records will be recorded using a data abstraction form.

Healthy and PCS participants will be scheduled for pre intervention physical, cognitive, neuroimaging, biomarker, and driving behaviour assessments at Lakehead University. All pre intervention assessments will be completed over the course of one week. At the first session, a member of the research team will complete the informed consent process; participants will be provided with a verbal overview of the study and the information letter. Following the informed consent process, healthy participants will complete the short form International Physical Activity Questionnaire.

Following the informed consent process, PCS participants will be provided with Garmin VivoSmart heart rate (HR) unit to monitor aerobic activity outside of the study (accelerometer, heart rate monitor, and step counter capabilities). Participants will be required to wear the Garmin units as often as possible for the duration of the study. Depending on scheduling, participant's will then complete one of the baseline assessments.

Baseline Assessments

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Man or woman aged 18-50 years.
  • Reports at least one PCS symptom that is mild in severity.
  • It has been two weeks since date of injury.

排除标准

  • Has been previously diagnosed with a psychological/neurological disorder
  • Has been previously diagnosed with a substance abuse disorder/impairment,
  • Is currently seeking therapy/counseling
  • Does not have valid driver's license and 12 months of driving experience.

结局指标

主要结局

Brain-derived neurotropic factor

时间窗: 8 weeks

Saliva will be used to analyze brain-derived neurotropic factor

Star Excursion Balance Test (SEBT)

时间窗: 8 weeks

Measure of balance. Score is based on normalized percentage of maximum reach distance (0-100%) with 100% equal to a perfect score.

Immediate Post-Concussion Assessment Battery

时间窗: 8 weeks

Cognitive assessment-Composite score is generated from each subscale by averaging scores, with 100 being equal to a perfect score.

Driving simulator

时间窗: 8 weeks

Reaction time to several scenarios will be measured

Flanker task

时间窗: 8 weeks

Number of event related potentials will be measured during responses to stimuli

Oddball task

时间窗: 8 weeks

Number of event related potentials will be measured during responses to stimuli

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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