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临床试验/NCT07402733
NCT07402733尚未招募1 期

PIC Rehab: Psychologically Informed Cervicovestibular Rehabilitation for Mild Traumatic Brain Injury: A Feasibility Trial

Sport Injury Prevention Research Centre1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
Feasibility - Recruitment

研究概览

简要总结

Mild traumatic brain injuries ("mTBIs") affect over 480,000 Canadians each year. While many individuals recover in the initial 4 weeks following mTBI, in up to 30% of individuals symptoms and functional impairments often persist leading to significant disability, decreased quality of life and participation in education, physical and occupational related activities. An assessment that evaluates multiple systems is recommended for individuals with mTBI, often involving multiple health care professionals to assess different areas of function (e.g. oculomotor, vestibular, balance, mood, cognition, etc). Current evidence supports the use of cervicovestibular rehabilitation (CVPT) (which includes physiotherapy techniques aimed at treating the neck, balance, visual and other sensory systems) and symptom-tolerated exercise. Evidence suggests that collaborative care, cognitive behavioural therapy (CBT) may be of benefit. However, the added value of CVPT and CBT in combination co-designed by patients and community partners has not yet been evaluated in mTBI. In other pain and dizziness conditions, the addition of CBT to physical/vestibular rehabilitation yielded improved outcomes. Here we take a transdisciplinary team-based approach to evaluate an integrated combination of CVPT and CBT.

This study will recruit a total of 34 people ages 18-70 years old who have ongoing symptoms following an mTBI for more than two weeks. The first 17 patients will receive CVPT along and the second 17 patients will receive psychologically informed CVPT ("PIC" Rehab). This study will help determine if combined therapy has an additive effect on helping patients recovery from mTBI.

详细描述

Problem: Mild traumatic brain injuries and concussions affect over 480,000 or 1.2% of Canadians each year.1-3 While many individuals recover in the initial 4 weeks following mTBI, up to 30% have persisting symptoms and functional impairments, leading to significant disability, decreased quality of life, and reduced participation in education, physical, and occupational related activities.

Dizziness, balance problems, headaches, and neck pain: Headaches and dizziness are consistently the most commonly reported symptoms following mTBI with estimates of up to 95% of individuals reporting headaches and 40-80% reporting dizziness. In a majority of cases, these symptoms are reported concurrently. Standing balance and dynamic balance deficits have consistently been identified following mTBI, some of which resolve early post-injury (within 3-5 days), while some balance problems remain for weeks to months following injury. Dizziness, balance problems, headaches, and neck pain are associated with greater odds of developing persisting symptoms. In addition, persisting dizziness, headaches, neck pain, and balance impairments can lead to decreased participation in recreational, social, occupational, and educational activities as well as lower quality of life. Decreased activity can, in turn, lead to significant morbidity due to secondary health complications. Therefore, treatments aimed at minimizing headaches, dizziness and balance problems following mTBI are urgently needed to minimize the public health burden of this commonly occurring injury.

Treatment of dizziness, balance problems, headaches, and neck pain following mTBI: Previous randomized controlled trials (RCTs) have identified large positive treatment effects following targeted cervical and vestibular rehabilitation (CVPT) for children, adolescents, and adults with dizziness, neck pain, and headaches following mTBI. These treatments are personalized, based on the individual's profile of specific impairments. CVPT includes treatments targeting neuromuscular and sensorimotor control in combination with manual therapy and soft tissue techniques as indicated. Specific rehabilitation exercises are gradually progressed, performed in combination with symptom-tolerated aerobic exercise, and eventually evolve to task, context, and/or sport specific exercises. From a mechanistic standpoint, the goal of this treatment is to facilitate sensorimotor integration (i.e. integration of visual, vestibular, proprioceptive input and resultant motor output) and either reweigh central balancing of stimuli to optimize function of these systems or up-regulate the use of alternate systems in the event that one of the sensory systems is not optimally operating. Recent international consensus recommendations and clinical practice guidelines recommend CVPT as a treatment that has some of the strongest evidence to date to facilitate recovery. However, up to 27% of individuals may not respond to CVPT5, necessitating other treatment options.

Cognitive Behavioural Therapy: For individuals with persisting symptoms following mTBI, evidence supports the use of cognitive behavioural therapy (CBT). CBT is a form of treatment that uses multiple non-pharmacological strategies including education, behavioural and cognitive strategies. This form of non-pharmacological treatment has demonstrated safety and efficacy for a number of different conditions including insomnia, depression, mental health, and more recently for mTBI. For individuals with chronic pain, improvements in anxiety and depressive symptoms have been demonstrated but no difference in pain intensity or pain catastrophizing has been found to date. Patient centred approaches are necessary to optimize effectiveness. In individuals with dizziness, the addition of CBT to physical and/or vestibular rehabilitation may yielded improved outcomes.

Thus, CVPT and CBT in combination may have additive effects for individuals with mTBI. Here we take a transdisciplinary team-based approach to evaluate an integrated combination of CVPT and CBT.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will be blinded to the hypothesis of the study and to the opposite treatment group to which they are assigned. Thus, two separate consent forms will be used in the study - one for each type of treatment received.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Reporting dizziness, neck pain and/or headaches for at least 14 days following mild traumatic brain injury/concussion who are referred for cervicovestibular physiotherapy with one or more impairments related to the vestibular, oculomotor, sensorimotor, cervical spine, neuromuscular control.

排除标准

  • Patients who have previously undergone a session of cervicovestibular physiotherapy will be excluded

研究组 & 干预措施

Cervicovestibular Rehabilitation (CVPT)

Active Comparator

CVPT includes treatments targeting neuromuscular and sensorimotor control in combination with manual therapy and soft tissue techniques as indicated.5 16 Specific rehabilitation exercises are gradually progressed, performed in combination with symptom-tolerated aerobic exercise, and eventually evolve to task, context, and/or sport specific exercises.16 From a mechanistic standpoint, the goal of this treatment is to facilitate sensorimotor integration (i.e. integration of visual, vestibular, proprioceptive input and resultant motor output) and either reweigh central balancing of stimuli to optimize function of these systems or upregulate the use of alternate systems in the event that one of the sensory systems is not optimally operating.5 17 Recent international consensus recommendations and clinical practice guidelines recommend CVPT as a treatment that has some of the strongest evidence to date to facilitate recovery.14 18

干预措施: Cervicovestibular Rehabilitation (CVPT) (Behavioral)

Psychologically Informed CVPT (PIC Rehab)

Experimental

Cognitive behavioural therapy (CBT) is a form of treatment that uses multiple non-pharmacological strategies including education, behavioural and cognitive strategies to assist with decreasing symptoms. The experimental PIC Rehab arm will include principles of CBT in combination with the CVPT.

干预措施: Psychologically Informed CVPT (PIC) Rehab (Behavioral)

Psychologically Informed CVPT (PIC Rehab)

Experimental

Cognitive behavioural therapy (CBT) is a form of treatment that uses multiple non-pharmacological strategies including education, behavioural and cognitive strategies to assist with decreasing symptoms. The experimental PIC Rehab arm will include principles of CBT in combination with the CVPT.

干预措施: Cervicovestibular Rehabilitation (CVPT) (Behavioral)

结局指标

主要结局

Feasibility - Recruitment

时间窗: From enrollment to the end of treatment at 8 weeks.

Number of participants recruited

Feasibility - retention rate

时间窗: From enrolment to the end of treatment at 8 weeks

Number of participants completing the trial divided by the total number of participants recruited

Feasibility - Adverse events

时间窗: From enrolment to the end of treatment at 8 weeks

Total number of adverse events

Feasibility - barriers and facilitators

时间窗: From enrolment to the end of treatment at 8 weeks.

Barriers and facilitators to the protocol as described by the participants and the physiotherapists.

Feasibility - Adherence to protocol by therapist

时间窗: From enrolment to the end of treatment at 8 weeks.

Adherence will be measured through voice recording review of the therapist treatment prescription in comparison to the specific group treatment protocol. The choice of treatment by the therapist will be matched to the treatment choice on the treatment protocol and rated as "yes" adheres or "no" does not adhere for each component of treatment at each recorded session. The proportion of components adhered to will be summarized.

次要结局

  • Symptom Severity Score (SSS)(Initial and 8 weeks)
  • Date of Medical Clearance to Return to Sport(From enrolment until treatment completion at 8 weeks)
  • Date of Return to full learn(From enrolment to the end of treatment at 8 weeks.)
  • Return to work(From enrolment to end of treatment at 8 weeks)

研究者

发起方
Sport Injury Prevention Research Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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