Shin Splint Clinical Trial
Official title:
Gait-Training Using Wearable Sensors for Runners With Exercise-Related Lower Leg Pain
NCT number | NCT04270565 |
Other study ID # | 22107 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 5, 2020 |
Est. completion date | May 31, 2021 |
Verified date | May 2022 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 20 |
Est. completion date | May 31, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Gymnasium - Exercise and Sport Injury Laboratory | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Contact Time | the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Change in Contact Time Across the Intervention Period | the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors | This outcome change will be assessed through study completion over 4 weeks for both groups. | |
Primary | Maintaining Change in Contact Time | the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors | This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups. | |
Primary | Change in Hip Frontal Plane Motion | Hip frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Change in Gluteus Medius Electromyography | Normalized gluteus medius muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Change in Tibialis Anterior Electromyography | Normalized tibialis anterior muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Change in Pain Outcomes | Visual Analog Scale (0-100 mm) pain outcome scores | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Maintaining Change in Pain Outcomes | Visual Analog Scale (0-100 mm) pain outcome scores | This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups. | |
Primary | Maintaining Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes | Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores | This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups. | |
Primary | Change in Pain Outcomes Across the Intervention Period | Visual Analog Scale (0-100 mm) pain outcome scores | This outcome change will be assessed through study completion over 4 weeks for both groups. | |
Primary | Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes | Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Change in Step Rate | the step rate per minute (in steps/min) during running as measured using the RunScribe sensors | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Change in Stride Length | the distance the legs reach out (in meters) during running as measured using the RunScribe sensors | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Change in Maximum Pronation Velocity | the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Change in Shock | the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Change in Foot Strike Type | 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 | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Primary | Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes Across the Intervention Period | Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores | This outcome change will be assessed through study completion over 4 weeks for both groups. | |
Secondary | Change in Peroneus Longus Electromyography | Normalized peroneus longus muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Medial Gastocnemius Electromyography | Normalized medial gastrocnemius muscle activity root mean square electromyography measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Foot Strike Type Across the Intervention Period | 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 | This outcome change will be assessed through study completion over 4 weeks for both groups. | |
Secondary | Change in Shock Across the Intervention Period | the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors | This outcome change will be assessed through study completion over 4 weeks for both groups. | |
Secondary | Change in Maximum Pronation Velocity Across the Intervention Period | the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors | This outcome change will be assessed through study completion over 4 weeks for both groups. | |
Secondary | Change in Stride Length Across the Intervention Period | the distance the legs reach out (in meters) during running as measured using the RunScribe sensors | This outcome change will be assessed through study completion over 4 weeks for both groups. | |
Secondary | Change in Step Rate Across the Intervention Period | the step rate per minute (in steps/min) during running as measured using the RunScribe sensors | This outcome change will be assessed through study completion over 4 weeks for both groups. | |
Secondary | Maintaining Change in Foot Strike Type | 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 | This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups. | |
Secondary | Maintaining Change in Shock | the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors | This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups. | |
Secondary | Maintaining Change in Maximum Pronation Velocity | the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors | This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups. | |
Secondary | Maintaining Change in Stride Length | the distance the legs reach out (in meters) during running as measured using the RunScribe sensors | This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups. | |
Secondary | Maintaining Change in Step Rate | the step rate per minute (in steps/min) during running as measured using the RunScribe sensors | This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups. | |
Secondary | Change in Hip Sagittal Plane Motion | Hip sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hip Sagittal Plane Kinetics | Hip sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hip Transverse Plane Motion | Hip transverse plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hip Transverse Plane Kinetics | Hip transverse plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hip Frontal Plane Kinetics | Hip frontal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Knee Frontal Plane Motion | Knee frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Knee Frontal Plane Kinetics | Knee frontal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Knee Sagittal Plane Kinetics | Knee sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Ankle Sagittal Plane Motion | Ankle sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Ankle Sagittal Plane Kinetics | Ankle sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Knee Sagittal Plane Motion | Knee sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Trunk Frontal Plane Motion | Trunk frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Trunk Sagittal Plane Motion | Trunk sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Trunk Frontal Plane Kinetics | Trunk frontal plane joint moment (in Nm/kg)measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Trunk Sagittal Plane Kinetics | Trunk sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill | This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Maintaining Global Change Outcomes | Global Rating of Change Scale (11-point scale) | This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups. | |
Secondary | Maintaining Recovery Outcomes | Wisconsin Injury and Recovery Scale (0-100%) | This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups. | |
Secondary | Change in Recovery Outcomes Across the Intervention Period | Wisconsin Injury and Recovery Scale (0-100%) | This outcome change will be assessed through study completion over 4 weeks for both groups. | |
Secondary | Change in Global Change Outcomes Across the Intervention Period | Global Rating of Change Scale (11-point scale) | This outcome change will be assessed through study completion over 4 weeks for both groups. | |
Secondary | Change in Single-Leg Squat Outcomes | single-leg squat to 45 degrees of knee flexion functional performance scores (valgus, varus, or neutral scoring) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Lateral Step-Down Outcomes | lateral step-down from a 35 cm box functional performance scores (valgus, varus, or neutral scoring) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Star Excursion Balance Test Outcomes | star excursion balance test performance scores (reach distances as a % of leg length for 8 reach directions) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Visual Gait Analysis Outcomes | visual gait assessment functional performance score (valgus, neutral, or varus) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Foot Posture Outcomes | Clinical foot posture index assessment (23-point scale) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Arch Height Outcomes | Clinical arch height index assessment using a Jaktool (ratio of seated to standing measures) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Weight-Bearing Dorsiflexion Outcomes | Clinical weight-bearing dorsiflexion (knee-to-wall) assessment (in centimeters) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Ankle Plantarflexion Outcomes | Clinical range of motion assessment using standard goniometer (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Ankle Dorsiflexion Outcomes | Clinical range of motion assessment using standard goniometer (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Metatarsophalangeal Joint Flexion Outcomes | Clinical range of motion assessment using standard goniometer (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Metatarsophalangeal Joint Extension Outcomes | Clinical range of motion assessment using standard goniometer (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hip Abduction Outcomes | Clinical range of motion assessment using standard goniometer (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Ankle Inversion Outcomes | Clinical range of motion assessment using standard goniometer (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Ankle Eversion Outcomes | Clinical range of motion assessment using standard goniometer (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Knee Flexion Outcomes | Clinical range of motion assessment using standard goniometer (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Tibial Torsion Outcomes | Clinical range of motion assessment using standard goniometer (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hip Anteversion Outcomes | Clinical range of motion assessment using standard goniometer (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hamstring Flexibility Outcomes | Clinical test assessing hamstring flexibility, called the 90/90 straight leg raise test (in degrees) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hip Flexor Flexibility Outcomes | Clinical test assessing hip flexor flexibility, called the Thomas test (in centimeters) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Metatarsophalangeal Joint Flexion Strength Outcomes | Clinical test assessing strength using hand-held dynamometry (in N/kg) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Ankle Dorsiflexion Strength Outcomes | Clinical test assessing strength using hand-held dynamometry (in N/kg) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Ankle Plantarflexion Strength Outcomes | Clinical test assessing strength using hand-held dynamometry (in N/kg) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Ankle Inversion Strength Outcomes | Clinical test assessing strength using hand-held dynamometry (in N/kg) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Ankle Eversion Strength Outcomes | Clinical test assessing strength using hand-held dynamometry (in N/kg) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hip Flexion Strength Outcomes | Clinical test assessing strength using hand-held dynamometry (in N/kg) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hip Extension Strength Outcomes | Clinical test assessing strength using hand-held dynamometry (in N/kg) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Hip Abduction Strength Outcomes | Clinical test assessing strength using hand-held dynamometry (in N/kg) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Knee Extensor Strength Outcomes | Clinical test assessing strength using hand-held dynamometry (in N/kg) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. | |
Secondary | Change in Knee Flexor Strength Outcomes | Clinical test assessing strength using hand-held dynamometry (in N/kg) | This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups. |
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