Anterior Cruciate Ligaments: Studying Updates in neuroCognition After Knee Manipulation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Simple Reaction Time
研究概览
简要总结
This study will investigate whether knee joint manipulation can improve neurocognitive and neuromuscular performance in individuals with a history of anterior cruciate ligament reconstruction (ACLR). Recruitment will consist of 30 participants aged 18-35 who are 4 months to 5 years post-ACLR and demonstrate measurable reaction time delays. Using a within-subject pre-post design, participants will complete a battery of neurocognitive and neuromuscular assessments, including visuomotor reaction time and dual-task hop testing, before and after knee joint manipulation(s).
The main questions the investigators aim to address are:
Aim 1: Evaluate the feasibility, acceptability, and applicability of integrating knee joint manipulation into post-ACLR rehabilitation using the Implementation and Outcomes Framework.
Aim 2: Determine preliminary efficacy of knee joint manipulation on neurocognitive performance in individuals with ACLR.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided informed consent prior to any study procedures that are performed.
- •Are between the ages of 18 and
- •Have undergone ACLR surgery. All autograft and allograft types are accepted.
- •Are 4-months to 10-years post-ACLR.
- •Injured knee playing or training for sports (recreational or organized) or during physical activity.
- •Have been cleared by a physician to return to activities and/or participate in this study.
- •Are at least the minimally clinical important difference (MCID) above the normative reaction time average for our methods as established by previous literature in at least 1 reaction time task.
排除标准
- •History of concussion in the past 3 months.
- •The participant is pregnant.
- •Have a neurological disorder, including epilepsy.
- •Currently injured or have injured their lower extremity in the past 3 months.
- •Had surgery on multiple ligaments when their ACL was injured.
结局指标
主要结局
Change in Simple Reaction Time
时间窗: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
Simple reaction time is the amount of time it takes for a person to respond to a single, known stimulus with a predefined response (ms). It is a basic measure of neuromuscular and cognitive processing speed. This is collected with the Senaptec Sensory Station.
Change in Lower Extremity Visuomotor Reaction Time
时间窗: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
Visuomotor reaction time refers to the time it takes for an individual to see a visual stimulus and then generate a coordinated motor response to it (ms). It combines two processes: visual perception and motor execution. This is collected with the Fitlight system.
Mean Feasibility of Joint Manipulation Score
时间窗: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
Collected with the Feasibility of Intervention Measure (FIM). Feasibility refers to how practical and achievable a study or project is in terms of its design, implementation, and resources. The FIM consists of four questions on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). The total score the four questions (4-20) will be averaged across all participants. Higher scores indicate greater feasibility. In this study, only patient perception is evaluated.
Mean Acceptability of Joint Manipulation Score
时间窗: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
Collected with the Acceptability of Intervention Measure (AIM). Acceptability refers to how well a study's intervention, procedures, or overall design are perceived and tolerated by participants, clinicians, or other stakeholders. The AIM consists of four questions on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). The total score the four questions (4-20) will be averaged across all participants. Higher scores indicate greater acceptability. In this study, only patient perception is evaluated.
Mean Appropriateness of Joint Manipulation Score
时间窗: Baseline and up to 90 minutes after completion of joint manipulation (intervention)
Collected with the Intervention Appropriateness Measure (IAM). Appropriateness refers to the extent to which an intervention, method, or study design is suitable for the specific context, population, or problem being addressed. The IAM consists of four questions on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). The total score the four questions (4-20) will be averaged across all participants. Higher scores indicate greater appropriateness. This will only take into account the patient's response.
次要结局
- Change in Mean Single Leg Hop Distance For Level 1 Neurocognitive Hop Test(Baseline and up to 90 minutes after completion of joint manipulation (intervention))
- Change in Mean Reaction Time For Level 1 Neurocognitive Hop Test(Baseline and up to 90 minutes after completion of joint manipulation (intervention))
- Change in Mean Single Leg Hop Distance For Level 2 Neurocognitive Hop Test(Baseline and up to 90 minutes after completion of joint manipulation (intervention))
- Change in Mean Reaction Time For Level 2 Neurocognitive Hop Test(Baseline and up to 90 minutes after completion of joint manipulation (intervention))
- Change in Mean Single Leg Hop Distance For Level 3 Neurocognitive Hop Test(Baseline and up to 90 minutes after completion of joint manipulation (intervention))
- Change in Mean Reaction Time For Level 3 Neurocognitive Hop Test(Baseline and up to 90 minutes after completion of joint manipulation (intervention))