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临床试验/NCT03418051
NCT03418051已完成不适用

Neuromuscular Mechanisms of Manual Therapies in Chronic Ankle Instability Patients

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月1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
60
试验地点
2
主要终点
ML COP Velocity From Baseline to Post Intervention

研究概览

简要总结

ABSTRACT:

Injury associated with sport and recreation is a leading reason for physical activity cessation, which is linked with significant long-term negative consequences. Lateral ankle sprains are the most common injuries associated with physical activity and at least 40% of individuals who sprain their ankle will go on to develop chronic ankle instability (CAI), a multifaceted condition linked with life-long residual symptoms and post-traumatic ankle osteoarthritis. Our long term goal is to develop intervention strategies to decrease disability associated with acute and chronic ankle injury and prevent posttraumatic ankle osteoarthritis. Conventional rehabilitation strategies, are only moderately successful because they ignore the full spectrum of residual symptoms associated with CAI. Manual therapies such as ankle joint mobilizations and plantar massage target sensory pathways not addressed by conventional treatments and have been shown to improve patient-reported outcomes, dorsiflexion range of motion, and postural control in CAI patients. While these early results are promising, the underlying neuromuscular mechanisms of these manual therapies remain unknown. Therefore the objective of this R21 proposal is to determine the neuromuscular mechanisms underlying the improvements observed following independent ankle joint mobilization and plantar massage interventions in CAI patients. To comprehensively evaluate the neuromuscular mechanisms of the experimental treatments, baseline assessments of peripheral (ankle joint proprioception, light-touch detection thresholds, spinal (H-Reflex of the soleus and fibularis longus), and supraspinal mechanisms (cortical activation, cortical excitability, and cortical mapping, sensory organization) will be assessed. Participants will then be randomly assigned to receive ankle joint mobilizations (n=20), plantar massage (n=20), or a control intervention (n=20) which will consist of 6, 5-minute treatments over 2-weeks. Post-intervention assessments will be completed within 48-hours of the final treatment session. Separate ANOVAs will assess the effects of treatment group (ankle joint mobilization, plantar massage, control) and time (baseline, post-treatment) on peripheral, spinal, and supraspinal neuromuscular mechanisms in CAI participants. Associations among neuromuscular mechanisms and secondary measures (biomechanics and postural control) will also be assessed. The results of this investigation will elucidate multifaceted mechanisms of novel and effective manual therapies (ankle joint mobilizations and plantar massage) in those with CAI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

ML COP Velocity From Baseline to Post Intervention

时间窗: Baseline and 24-72 hours post intervention

% Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.

ML COP Velocity From Baseline to Follow-Up

时间窗: Baseline and 4-week Follow-Up

% Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the Follow-Up assessment.

AP COP Velocity From Baseline to Follow-up

时间窗: Baseline and 4-week Follow-Up

% Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the follow-up assessment.

AP TTB From Baseline to Post Intervention

时间窗: Baseline and 24-72 hours post intervention

% Modulation of AP Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.

95% Confidence Ellipse From Baseline to Follow-Up

时间窗: Baseline and 4-week Follow-Up

% Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion \[movement\] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.

AP COP Velocity From Baseline to Post Intervention

时间窗: Baseline and 24-72 hours post intervention

% Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction \[front to back\]. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.

ML TTB From Baseline to Post Intervention

时间窗: Baseline and 24-72 hours post intervention

% Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.

ML TTB From Baseline to Follow-Up

时间窗: Baseline and 4-week Follow-Up

% Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction \[side to side\] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.

95% Confidence Ellipse From Baseline to Post Intervention

时间窗: Baseline and 24-72 hours post intervention

% Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion \[movement\] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value \>100%. This analysis focused on baseline to the immediate post-treatment assessment.

AP TTB From Baseline to Follow-Up

时间窗: Baseline and 4-week Follow-Up

% Modulation of AP Time-to-Boundary. First, time-to-Boundary is calculated in the anterioposterior (AP) direction \[front to back\] with eyes open and closed. Time-to-boundary represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.

次要结局

  • Plantar Flexion Joint Position Sense From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up(Baseline and 4-week Follow Up)
  • Corticomotor Map Area From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • Plantar Flexion Joint Position Sense From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • Soleus H:M Ratio From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • Soleus H:M Ratio From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • Fibularis Longus H:M Ratio From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • Fibularis Longus H:M Ratio From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • Fibularis Longus Active Motor Threshold From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • Fibularis Longus Active Motor Threshold From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • Cortical Silent Period From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • Cortical Silent Period From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • Corticomotor Map Area From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • Corticomotor Map Volume From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • Gamma Power Spectral Density From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • Corticomotor Map Volume From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • Alpha Power Spectral Density From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • Alpha Power Spectral Density From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • Beta Power Spectral Density From Baseline to Follow-Up(Baseline and 4-week Follow-Up)
  • Gamma Power Spectral Density From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)
  • Beta Power Spectral Density From Baseline to Post Intervention(Baseline and 24-72 hours post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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