Shin SplintNCT04270565
Gait-Training Using Wearable Sensors
A study testing In-Field Gait-Training and Home Exercise in people with Shin Splint and Running-related Injury, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Shin Splint, Running-related Injury
- What is being tested?
- In-Field Gait-Training and Home Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Gymnasium - Exercise and Sport Injury Laboratory
Charlottesville, Virginia, 22904
About this study
Official title: Gait-Training Using Wearable Sensors for Runners With Exercise-Related Lower Leg Pain
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).
Read the detailed description
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.
At the midpoint of the study, all participants will complete Visual Analog and Global Rating of Change scales to track self-reported recovery. At the end of the intervention period, all participants will be re-assessed by the same blinded assessor using the same baseline measures to determine changes in lower limb alignment, strength, flexibility, and functional movement patterns. The indoor gait assessment and calibration run performed at the second baseline visit will be repeated at this follow-up timepoint while all participants wear the RunScribe sensors. Participants will also repeat Visual Analog Pain and Global Rating of Change scales to assess self-reported recovery. The investigators will then be able to determine if contact time feedback delivered in the field effectively decreases contact time after feedback compared to baseline and compared to the control group, determine if contact time feedback delivered in the field carries over to other gait outcomes in the intervention group after gait-training compared to baseline and the control group, and assess if pain decreases and function increases after gait-training compared to baseline and to a greater extent than the control group.
- Conditions
- Shin Splint, Running-related Injury
- Being tested
- In-Field Gait-Training, Home Exercise
- Keywords
- running, gait-training, exercise-related lower leg pain, wearable sensors
- Medical subject headings
- Medial Tibial Stress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Field Gait-TrainingBehavioural
Also called RunScribe, Garmin
The intervention will deliver a series of vibrations on the participants' wrists through the Garmin when the sensors indicate that their contact time in milliseconds exceeds a threshold. The runners will be asked to reduce the amount of time their foot is in contact with the ground by picking their feet up more quickly. Participants will also receive a series of exercises based on noted impairments at baseline. The feedback during running will be completed twice per week for four weeks.
Home ExerciseBehavioural
Participants will receive a series of exercises based on noted impairments at baseline. Exercises will be completed twice per week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive real-time gait-training interventions along with a home exercise program. Participants in this group will be given a pair of sensors to wear on their shoes to wear during runs throughout the study period, and wear a Garmin watch to get information from the sensors to the watch for feedback. They will also do home exercises during the study, and to come into the laboratory weekly for about 30 minutes per visit to progress the home exercises and get instructions on feedback for the next week. Receives: Behavioral: In-Field Gait-Training; Behavioral: Home Exercise |
| Control Group | Active comparator | The control group will receive only a home exercise program. Participants in this group will be given a pair of sensors to wear on their shoes to wear during runs throughout the study period, and do home exercises during the study. Participants will be asked to come into the laboratory weekly for about 30 minutes per visit to progress the home exercises. Receives: Behavioral: Home Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Contact Time
the amount of time (in milliseconds) the foot is in contact with the ground as measured using the RunScribe sensors
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
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
Measured: This outcome change will be assessed through study completion over 4 weeks for both groups.
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
Measured: 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 Frontal Plane Motion
Hip frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Measured: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
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
Measured: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
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
Measured: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Pain Outcomes
Visual Analog Scale (0-100 mm) pain outcome scores
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Maintaining Change in Pain Outcomes
Visual Analog Scale (0-100 mm) pain outcome scores
Measured: 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 Exercise-Induced Leg Pain Questionnaire - British Version Outcomes
Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores
Measured: 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 Pain Outcomes Across the Intervention Period
Visual Analog Scale (0-100 mm) pain outcome scores
Measured: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes
Exercise Induced Leg Pain Questionnaire - British Version (0-100%) outcome scores
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Step Rate
the step rate per minute (in steps/min) during running as measured using the RunScribe sensors
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Stride Length
the distance the legs reach out (in meters) during running as measured using the RunScribe sensors
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
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
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Shock
the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
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
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
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
Measured: This outcome change will be assessed through study completion over 4 weeks for both groups.
Secondary outcomes (60)
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
Measured: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
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
Measured: 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
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
Measured: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Shock Across the Intervention Period
the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors
Measured: This outcome change will be assessed through study completion over 4 weeks for both groups.
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
Measured: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Stride Length Across the Intervention Period
the distance the legs reach out (in meters) during running as measured using the RunScribe sensors
Measured: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Step Rate Across the Intervention Period
the step rate per minute (in steps/min) during running as measured using the RunScribe sensors
Measured: This outcome change will be assessed through study completion over 4 weeks for both groups.
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
Measured: 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 Shock
the extent of lower extremity loading (in g's) during running as measured using the RunScribe sensors
Measured: 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 Maximum Pronation Velocity
the speed in which the foot turns over, or pronates, (in degrees/sec) during running as measured using the RunScribe sensors
Measured: 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
the distance the legs reach out (in meters) during running as measured using the RunScribe sensors
Measured: 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
the step rate per minute (in steps/min) during running as measured using the RunScribe sensors
Measured: 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
Hip sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Measured: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
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
Measured: 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
Hip transverse plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Measured: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
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
Measured: 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
Hip frontal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Measured: 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
Knee frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Measured: 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
Knee frontal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Measured: 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
Knee sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Measured: 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
Ankle sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Measured: 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
Ankle sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Measured: 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
Knee sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Measured: 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
Trunk frontal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Measured: 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
Trunk sagittal plane motion (in degrees) measured during the indoor motion capture gait analysis on a treadmill
Measured: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
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
Measured: 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
Trunk sagittal plane joint moment (in Nm/kg) measured during the indoor motion capture gait analysis on a treadmill
Measured: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Maintaining Global Change Outcomes
Global Rating of Change Scale (11-point scale)
Measured: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Maintaining Recovery Outcomes
Wisconsin Injury and Recovery Scale (0-100%)
Measured: 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 Recovery Outcomes Across the Intervention Period
Wisconsin Injury and Recovery Scale (0-100%)
Measured: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Global Change Outcomes Across the Intervention Period
Global Rating of Change Scale (11-point scale)
Measured: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Single-Leg Squat Outcomes
single-leg squat to 45 degrees of knee flexion functional performance scores (valgus, varus, or neutral scoring)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Lateral Step-Down Outcomes
lateral step-down from a 35 cm box functional performance scores (valgus, varus, or neutral scoring)
Measured: 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
star excursion balance test performance scores (reach distances as a % of leg length for 8 reach directions)
Measured: 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
visual gait assessment functional performance score (valgus, neutral, or varus)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Foot Posture Outcomes
Clinical foot posture index assessment (23-point scale)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Arch Height Outcomes
Clinical arch height index assessment using a Jaktool (ratio of seated to standing measures)
Measured: 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
Clinical weight-bearing dorsiflexion (knee-to-wall) assessment (in centimeters)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Plantarflexion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Dorsiflexion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Measured: 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
Clinical range of motion assessment using standard goniometer (in degrees)
Measured: 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
Clinical range of motion assessment using standard goniometer (in degrees)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Abduction Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Inversion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Eversion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Knee Flexion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Tibial Torsion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Anteversion Outcomes
Clinical range of motion assessment using standard goniometer (in degrees)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hamstring Flexibility Outcomes
Clinical test assessing hamstring flexibility, called the 90/90 straight leg raise test (in degrees)
Measured: 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
Clinical test assessing hip flexor flexibility, called the Thomas test (in centimeters)
Measured: 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
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Measured: 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
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Measured: 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
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Measured: 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
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Measured: 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
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Measured: 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
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Measured: 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
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Measured: 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
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Measured: 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
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Measured: 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
Clinical test assessing strength using hand-held dynamometry (in N/kg)
Measured: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start5 Feb 2020
- Primary completion30 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Shin SplintStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups: 1. real-time gait-training interventions along with a home exercise program (intervention group) 2. only home exercise program (control group).
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Hertel, PhD, ATC, University of Virginia
- Investigators
- Jay Hertel, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270565
- Sponsor's protocol ID
- 22107
- Status last verified
- May 2022
- First submitted
- 10 Feb 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Willy RW. Innovations and pitfalls in the use of wearable devices in the prevention and rehabilitation of running related injuries. Phys Ther Sport. 2018 Jan;29:26-33. doi: 10.1016/j.ptsp.2017.10.003. Epub 2017 Oct 6.
PubMed 29172095Koldenhoven RM, Hertel J. Validation of a Wearable Sensor for Measuring Running Biomechanics. Digit Biomark. 2018 Aug 2;2(2):74-78. doi: 10.1159/000491645. eCollection 2018 May-Aug.
PubMed 32095758Hollis CR, Koldenhoven RM, Resch JE, Hertel J. Running biomechanics as measured by wearable sensors: effects of speed and surface. Sports Biomech. 2021 Aug;20(5):521-531. doi: 10.1080/14763141.2019.1579366. Epub 2019 Mar 7.
PubMed 30843475DeJong AF, Hertel J. Gait-training devices in the treatment of lower extremity injuries in sports medicine: current status and future prospects. Expert Rev Med Devices. 2018 Dec;15(12):891-909. doi: 10.1080/17434440.2018.1551130. Epub 2018 Dec 10.
PubMed 30466335Willems TM, Witvrouw E, De Cock A, De Clercq D. Gait-related risk factors for exercise-related lower-leg pain during shod running. Med Sci Sports Exerc. 2007 Feb;39(2):330-9. doi: 10.1249/01.mss.0000247001.94470.21.
PubMed 17277598Reinking MF, Hayes AM. Intrinsic factors associated with exercise-related leg pain in collegiate cross-country runners. Clin J Sport Med. 2006 Jan;16(1):10-4. doi: 10.1097/01.jsm.0000188041.04760.d2.
PubMed 16377969Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
PubMed 11733293Korakakis V, Malliaropoulos N, Baliotis K, Papadopoulou S, Padhiar N, Nauck T, Lohrer H. Cross-cultural Adaptation and Validation of the Exercise-Induced Leg Pain Questionnaire for English- and Greek-Speaking Individuals. J Orthop Sports Phys Ther. 2015 Jun;45(6):485-96. doi: 10.2519/jospt.2015.5428. Epub 2015 Apr 30.
PubMed 25927499Abbott JH, Wright AA. Global Rating of Change (GROC): the minimally important change at which patients choose to stop seeking treatment. N Z J Physiother. 2010;38(2):66-66.
Nelson EO, Ryan M, AufderHeide E, Heiderscheit B. Development of the University of Wisconsin Running Injury and Recovery Index. J Orthop Sports Phys Ther. 2019 Oct;49(10):751-760. doi: 10.2519/jospt.2019.8868. Epub 2019 Aug 3.
PubMed 31378123DeJong Lempke AF, Stephens SL, Fish PN, Thompson XD, Hart JM, Hryvniak DJ, Rodu JS, Hertel J. Sensor-based gait training to reduce contact time for runners with exercise-related lower leg pain: a randomised controlled trial. BMJ Open Sport Exerc Med. 2022 Nov 3;8(4):e001293. doi: 10.1136/bmjsem-2021-001293. eCollection 2022.
PubMed 36353183
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait-Training Using Wearable Sensors for Runners With Exercise-Related Lower Leg Pain
- ClinicalTrials.gov ID
- NCT04270565
- Acronym / sponsor ID
- 22107
- Conditions
- Shin Splint, Running-related Injury
- Keywords
- running, gait-training, exercise-related lower leg pain, wearable sensors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
At the midpoint of the study, all participants will complete Visual Analog and Global Rating of Change scales to track self-reported recovery. At the end of the intervention period, all participants will be re-assessed by the same blinded assessor using the same baseline measures to determine changes in lower limb alignment, strength, flexibility, and functional movement patterns. The indoor gait assessment and calibration run performed at the second baseline visit will be repeated at this follow-up timepoint while all participants wear the RunScribe sensors. Participants will also repeat Visual Analog Pain and Global Rating of Change scales to assess self-reported recovery. The investigators will then be able to determine if contact time feedback delivered in the field effectively decreases contact time after feedback compared to baseline and compared to the control group, determine if contact time feedback delivered in the field carries over to other gait outcomes in the intervention group after gait-training compared to baseline and the control group, and assess if pain decreases and function increases after gait-training compared to baseline and to a greater extent than the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two groups: 1. real-time gait-training interventions along with a home exercise program (intervention group) 2. only home exercise program (control group).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: In-Field Gait-Training, Behavioral: Home ExerciseThe intervention group will receive real-time gait-training interventions along with a home exercise program. Participants in this group will be given a pair of sensors to wear on their shoes to wear during runs throughout the study period, and wear a Garmin watch to get information from the sensors to the watch for feedback. They will also do home exercises during the study, and to come into the laboratory weekly for about 30 minutes per visit to progress the home exercises and get instructions on feedback for the next week. |
| Control Group | Active comparator | Behavioral: Home ExerciseThe control group will receive only a home exercise program. Participants in this group will be given a pair of sensors to wear on their shoes to wear during runs throughout the study period, and do home exercises during the study. Participants will be asked to come into the laboratory weekly for about 30 minutes per visit to progress the home exercises. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Field Gait-TrainingAlso: RunScribe, GarminThe intervention will deliver a series of vibrations on the participants' wrists through the Garmin when the sensors indicate that their contact time in milliseconds exceeds a threshold. The runners will be asked to reduce the amount of time their foot is in contact with the ground by picking their feet up more quickly. Participants will also receive a series of exercises based on noted impairments at baseline. The feedback during running will be completed twice per week for four weeks. | Behavioural | Intervention Group |
| Home ExerciseParticipants will receive a series of exercises based on noted impairments at baseline. Exercises will be completed twice per week for four weeks. | Behavioural | Control Group, Intervention Group |
Primary outcome
Change in Contact Time
Time frame: 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 Contact Time Across the Intervention Period
Time frame: 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 Contact Time
Time frame: 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 Hip Frontal Plane Motion
Time frame: 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 Gluteus Medius Electromyography
Time frame: 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 Tibialis Anterior Electromyography
Time frame: 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 Pain Outcomes
Time frame: 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
Maintaining Change in Pain Outcomes
Time frame: 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
Maintaining Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes
Time frame: 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
Change in Pain Outcomes Across the Intervention Period
Time frame: 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 Exercise-Induced Leg Pain Questionnaire - British Version Outcomes
Time frame: 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 Step Rate
Time frame: 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
Change in Stride Length
Time frame: 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 Maximum Pronation Velocity
Time frame: 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 Shock
Time frame: 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
Time frame: 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
Change in Exercise-Induced Leg Pain Questionnaire - British Version Outcomes Across the Intervention Period
Time frame: 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
60 secondary outcomes
Change in Peroneus Longus Electromyography
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Medial Gastocnemius Electromyography
Time frame: 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
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Shock Across the Intervention Period
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Maximum Pronation Velocity Across the Intervention Period
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Stride Length Across the Intervention Period
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Step Rate Across the Intervention Period
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Maintaining Change in Foot Strike Type
Time frame: 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 Shock
Time frame: 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 Maximum Pronation Velocity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Sagittal Plane Kinetics
Time frame: 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
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Hip Transverse Plane Kinetics
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Change in Trunk Frontal Plane Kinetics
Time frame: 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
Time frame: This outcome change will be measured from baseline to the end of the intervention (4 weeks) for both groups.
Maintaining Global Change Outcomes
Time frame: This outcome change will be assessed from the end of the intervention (4 weeks) to follow-up at 6 weeks for both groups.
Maintaining Recovery Outcomes
Time frame: 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 Recovery Outcomes Across the Intervention Period
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Global Change Outcomes Across the Intervention Period
Time frame: This outcome change will be assessed through study completion over 4 weeks for both groups.
Change in Single-Leg Squat Outcomes
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Lateral Step-Down Outcomes
Time frame: 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
Time frame: 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
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Foot Posture Outcomes
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Arch Height Outcomes
Time frame: 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
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Plantarflexion Outcomes
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Change in Ankle Dorsiflexion Outcomes
Time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 29172095Willy RW. Innovations and pitfalls in the use of wearable devices in the prevention and rehabilitation of running related injuries. Phys Ther Sport. 2018 Jan;29:26-33. doi: 10.1016/j.ptsp.2017.10.003. Epub 2017 Oct 6.
- Background: PubMed 32095758Koldenhoven RM, Hertel J. Validation of a Wearable Sensor for Measuring Running Biomechanics. Digit Biomark. 2018 Aug 2;2(2):74-78. doi: 10.1159/000491645. eCollection 2018 May-Aug.
- Background: PubMed 30843475Hollis CR, Koldenhoven RM, Resch JE, Hertel J. Running biomechanics as measured by wearable sensors: effects of speed and surface. Sports Biomech. 2021 Aug;20(5):521-531. doi: 10.1080/14763141.2019.1579366. Epub 2019 Mar 7.
- Background: PubMed 30466335DeJong AF, Hertel J. Gait-training devices in the treatment of lower extremity injuries in sports medicine: current status and future prospects. Expert Rev Med Devices. 2018 Dec;15(12):891-909. doi: 10.1080/17434440.2018.1551130. Epub 2018 Dec 10.
- Background: PubMed 17277598Willems TM, Witvrouw E, De Cock A, De Clercq D. Gait-related risk factors for exercise-related lower-leg pain during shod running. Med Sci Sports Exerc. 2007 Feb;39(2):330-9. doi: 10.1249/01.mss.0000247001.94470.21.
- Background: PubMed 16377969Reinking MF, Hayes AM. Intrinsic factors associated with exercise-related leg pain in collegiate cross-country runners. Clin J Sport Med. 2006 Jan;16(1):10-4. doi: 10.1097/01.jsm.0000188041.04760.d2.
- Background: PubMed 11733293Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
- Background: PubMed 25927499Korakakis V, Malliaropoulos N, Baliotis K, Papadopoulou S, Padhiar N, Nauck T, Lohrer H. Cross-cultural Adaptation and Validation of the Exercise-Induced Leg Pain Questionnaire for English- and Greek-Speaking Individuals. J Orthop Sports Phys Ther. 2015 Jun;45(6):485-96. doi: 10.2519/jospt.2015.5428. Epub 2015 Apr 30.
- BackgroundAbbott JH, Wright AA. Global Rating of Change (GROC): the minimally important change at which patients choose to stop seeking treatment. N Z J Physiother. 2010;38(2):66-66.
- Background: PubMed 31378123Nelson EO, Ryan M, AufderHeide E, Heiderscheit B. Development of the University of Wisconsin Running Injury and Recovery Index. J Orthop Sports Phys Ther. 2019 Oct;49(10):751-760. doi: 10.2519/jospt.2019.8868. Epub 2019 Aug 3.
- Derived from this study: PubMed 36353183DeJong Lempke AF, Stephens SL, Fish PN, Thompson XD, Hart JM, Hryvniak DJ, Rodu JS, Hertel J. Sensor-based gait training to reduce contact time for runners with exercise-related lower leg pain: a randomised controlled trial. BMJ Open Sport Exerc Med. 2022 Nov 3;8(4):e001293. doi: 10.1136/bmjsem-2021-001293. eCollection 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Hertel, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Field Gait-Training and Home Exercise in people with Shin Splint and Running-related Injury, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Contact Time (time frame: This outcome change will be assessed from baseline to the end of the intervention (4 weeks) for both groups.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270565, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.