Gait-Training Using Wearable Sensors for Runners With Exercise-Related Lower Leg Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Contact Time Across the Intervention Period
研究概览
简要总结
The overarching purpose of this project is to use sensor-derived patterns to guide running interventions during in-field training scenarios for runners with exercise-related lower leg pain. The investigators plan to use the RunScribe sensors to facilitate in-field gait-training to determine the effects of real-time gait-training interventions along with a home exercise program (intervention group) on biomechanical and patient-reported outcome measures of pain and function in runners with leg pain as opposed to receiving a home exercise program alone (control group).
详细描述
The purpose of the study is to determine the effects of real-time gait-training interventions along with a home exercise program (intervention group) on biomechanical and patient-reported outcome measures of pain and function in runners with leg pain as opposed to receiving a home exercise program alone (control group). All participants will report to the Exercise and Sport Injury Laboratory for a 60-minute baseline clinical assessment performed by a blinded assessor to determine hip, knee, foot and ankle strength, range of motion, and alignment using valid and reliable measurement techniques. Participants will also perform a series of functional movement assessments while an assessor records frontal and sagittal camera views in order to determine lower extremity dynamic alignment. The functional assessments will include the star excursion balance test (SEBT), a lateral step-down, a single-leg squat to 45 degrees of knee flexion, and a treadmill gait assessment. The movement screens will be use to form criteria-based home exercise programs, such that a blinded assessor will evaluate the videos and categorize patients into varus, valgus, or neutral alignment groups. Participants will receive exercises tailored to these descriptions. Further, the static alignment measurements will be used to determine if lower extremity stretches are warranted.
Following the first baseline visit, participants will return to the lab for a second baseline visit to complete an indoor, instrumented gait analysis using a motion capture system. Participants will also become oriented to the RunScribe wearable sensors and associated phone application, and will perform a brief outdoor run at their preferred speed to calibrate the sensors. Participants will receive their home exercise prescription with supplemental videos to take home with them to ensure adequate understanding of the target exercise performance. Participants will then be randomly assigned to one of two groups: 1) sensor-based feedback with home exercises (intervention group), or 2) home exercises alone (control group). The randomization sequence will be created a priori with a random-number generator stratified by sex, and allocation will be placed in a sealed opaque envelope by the graduate student mentor to intentionally blind the study coordinator conducting the interventions.
Participants in the intervention group will receive a Garmin wristwatch to facilitate the gait-training feedback, and will be oriented to the procedures during 10 minutes of running on an indoor treadmill in the presence of the study coordinator to ensure adequate understanding and integration of the feedback. The RunScribe sensors will facilitate the feedback by providing real-time metrics on the Garmin watch face using a custom application. Contact time will be the central focus of the intervention; participants will receive a vibro-tactile alert to remain below the identified contact time cut-off based on preliminary data.
Regardless of group allocation, participants will be instructed to maintain a running log within the RunScribe phone application to track activity adherence, details of runs that are recorded by the sensors, and report pain 1-10 experienced before, during, and after runs. All participants will be asked to perform their interventions twice per week. Participants will be encouraged to maintain other normal activities in addition to the interventions.
During the intervention period, all participants will return to the lab once per week to determine if exercise progressions are warranted based using specific performance-based scoring criteria. These decisions will be made by an assessor blinded to group allocation. The intervention group participants will then check in with the unblinded study coordinator to receive instructions on gait-training feedback progressions. The intervention will follow a volume-based faded feedback design.
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 (Care Provider, Outcomes Assessor)
盲法说明
The investigator assessing laboratory-based outcome measures will be blinded to group allocation. Additionally, the investigator designing the home exercise program and making progression decisions will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-45 years
- •Male or female
- •Involved in running training at least two times per week over the past three months
- •Current weekly mileage of at least 6 miles
- •Currently experiencing pain during or after running in the anterior or medial aspect of the leg (between the knee and the ankle) of at least one week in duration, with maximum pain levels between 3/10 and 8/10 on the Visual Analogue Scale
- •All subjects must be willing to use their own smart phone device (iPhone or Android) to download the RunScribe application for study procedures.
排除标准
- •Primary complaint is of pain over the Achilles tendon, popliteal fossa, or lateral or superficial posterior compartment of the lower leg
- •Medical diagnosis of compartment syndrome, tibial or fibular stress fracture, or tibial or fibular fracture within the past 3 months
- •Current running-related injuries within 3 months at the foot, ankle, knee, thigh, hip, or lower back
- •Any history of lower extremity or lower back surgery
- •Subjects with known pregnancy
- •Subject with any type of neuropathy (numbness/tingling) in lower extremity
- •Subject with clinical diagnosis of Parkinson's disease
结局指标
主要结局
Change in Contact Time Across the Intervention Period
时间窗: This outcome change will be assessed through study completion over 4 weeks for both groups.
the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors
Maintaining Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes
时间窗: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores
Maintaining Change in Pain Outcomes
时间窗: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Visual Analog Scale (0-100 mm) pain outcome scores
Change in Gluteus Medius Electromyography
时间窗: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Normalized gluteus medius muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill
Change in Pain Outcomes Across the Intervention Period
时间窗: This outcome change will be assessed through study completion over 4 weeks for both groups.
Visual Analog Scale (0-100 mm) pain outcome scores
Change in Step Rate
时间窗: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
the step rate per minute (in steps/min) during running as measured using the RunScribe sensors
Maintaining Change in Contact Time
时间窗: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors
Change in Pain Outcomes
时间窗: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Visual Analog Scale (0-100 mm) pain outcome scores
Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes Across the Intervention Period
时间窗: This outcome change will be assessed through study completion over 4 weeks for both groups.
Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores
Change in Contact Time
时间窗: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors
Change in Hip Frontal Plane Motion
时间窗: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Hip frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes
时间窗: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores
Change in Maximum Pronation Velocity
时间窗: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors
Change in Tibialis Anterior Electromyography
时间窗: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Normalized tibialis anterior muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill
Change in Stride Length
时间窗: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
the distance the legs reach out (in meters) during running as measured using the RunScribe sensors
Change in Shock
时间窗: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors
Change in Foot Strike Type
时间窗: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
the area on the foot that participants land on (on a 1-16 scale, with 1 indicating rear foot strike and 16 indicating a forefoot strike) during running as measured using the RunScribe sensors
次要结局
- Change in Peroneus Longus Electromyography(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Trunk Sagittal Plane Motion(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Recovery Outcomes Across the Intervention Period(This outcome change will be assessed through study completion over 4 weeks for both groups.)
- Change in Maximum Pronation Velocity Across the Intervention Period(This outcome change will be assessed through study completion over 4 weeks for both groups.)
- Maintaining Change in Shock(This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.)
- Maintaining Change in Stride Length(This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.)
- Change in Hip Transverse Plane Kinetics(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Hip Frontal Plane Kinetics(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Knee Sagittal Plane Kinetics(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Ankle Sagittal Plane Kinetics(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Foot Strike Type Across the Intervention Period(This outcome change will be assessed through study completion over 4 weeks for both groups.)
- Change in Stride Length Across the Intervention Period(This outcome change will be assessed through study completion over 4 weeks for both groups.)
- Maintaining Change in Foot Strike Type(This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.)
- Change in Hip Sagittal Plane Motion(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Step Rate Across the Intervention Period(This outcome change will be assessed through study completion over 4 weeks for both groups.)
- Change in Trunk Frontal Plane Kinetics(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Arch Height Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Metatarsophalangeal Joint Extension Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Ankle Inversion Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Medial Gastocnemius Electromyography(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Shock Across the Intervention Period(This outcome change will be assessed through study completion over 4 weeks for both groups.)
- Maintaining Change in Maximum Pronation Velocity(This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.)
- Maintaining Change in Step Rate(This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.)
- Change in Hip Sagittal Plane Kinetics(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Knee Frontal Plane Motion(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Ankle Sagittal Plane Motion(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Trunk Sagittal Plane Kinetics(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Hip Transverse Plane Motion(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Knee Frontal Plane Kinetics(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Knee Sagittal Plane Motion(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Trunk Frontal Plane Motion(This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.)
- Maintaining Global Change Outcomes(This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.)
- Change in Global Change Outcomes Across the Intervention Period(This outcome change will be assessed through study completion over 4 weeks for both groups.)
- Change in Lateral Step-Down Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Star Excursion Balance Test Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Ankle Dorsiflexion Strength Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Hip Flexion Strength Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Maintaining Recovery Outcomes(This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.)
- Change in Single-Leg Squat Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Ankle Plantarflexion Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Metatarsophalangeal Joint Flexion Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Ankle Eversion Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Hamstring Flexibility Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Hip Flexor Flexibility Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Metatarsophalangeal Joint Flexion Strength Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Ankle Eversion Strength Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Visual Gait Analysis Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Ankle Dorsiflexion Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Knee Flexion Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Tibial Torsion Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Ankle Inversion Strength Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Hip Extension Strength Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Knee Flexor Strength Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Foot Posture Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Weight-Bearing Dorsiflexion Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Hip Abduction Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Hip Anteversion Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Ankle Plantarflexion Strength Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Hip Abduction Strength Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
- Change in Knee Extensor Strength Outcomes(This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.)
研究者
Jay Hertel, PhD, ATC
Joe H. Gieck Professor of Sports Medicine
University of Virginia