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CompletedNCT03486405Updated May 20, 2019

A Randomized Control Trial: Returning to Run After Injury

An interventional study of Control group and Intervention group in Knee Injuries, sponsored by Keller Army Community Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-20.

Sponsored by Keller Army Community Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 94 studies in Knee Injuries with a site in United States — 16 open to participants now, 24 under way, 1 of them phase 3. Knee Injuries · United States.

Enrollment
46th of 75
30 · median 40
Started
2018
with 7 others
No phase
57 of 94
10 open now
Registered
39th of 94
by date
Lead sponsor
3 of 94
Keller Army Community Hospital

Among the 94 studies in Knee Injuries with a site in United States, this one is the 46th largest by enrollment of the 75 interventional ones that give a count, is one of 8 that started in 2018, is one of 57 with no phase, and was the 39th registered.

Knee Injuries

267 studies on the registry are indexed under Knee Injuries; 59 are open to participants now.

Browse Knee Injuries studies →

Open to participants now

16 of the 94 studies in Knee Injuries with a site in United States are open now. Recruiting first, the newest first:

11 more — sign in →

All 16 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 42 Knee Injuries studies recruiting now, 12 (29%) set no upper age limit and 27 (64%) stop at 75 or younger; 12 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · healthy volunteers too.

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02

Study summary

The purpose of this study is to examine the effectiveness of telehealth via video feedback to transition rear foot strike runners to non-heel strike runner following a lower extremity injury. Telehealth re-education gait training is much cheaper than in-clinic retraining sessions with a medical provider and could be much more widely used by both consumers and researchers as a training aid, a way to help alter running form, prevent running injuries and be used as a tool for use in the rehabilitation of running related injuries.

Read the detailed description

A convenience sample of 30 runners from the United States Military Academy (USMA) at West Point, New York (NY) who are recovering from a lower-extremity injury and are interested in participating in a return to run program. Acceptable lower-extremity injuries can include stress fractures proximal to the ankle, anterior chronic exertional compartment syndrome (CECS), patella-femoral pain syndrome, osteoarthritis of the lower-extremity, iliotibial band syndrome, chronic lower-extremity pain and or any participant that may benefit from the following; shorter stride, increased step rate, reduced knee loading, and reduced ground reaction force average vertical loading rates (AVLR). All participants will be screened via questionnaire and physical assessment for inclusion / exclusion from the study. Upon enrollment runners will be randomized into two groups. Regardless of group, all runners will have their running form and foot strike pattern analyzed using an instrumented treadmill and high-speed motion capture initially and at week 10. Kinetic and kinematic data including AVLR, impulse, foot strike pattern (FSP), contact time, step length, and step rate will be recorded at these time points. Additionally, all runners will receive the same graduated return to run intervals and 4-week home exercise program. Runners randomized to the intervention group will receive additional video tele-health instruction on how to transition to a non-rearfoot strike (NRFS) running pattern. Runners in the intervention group will have additional tele-health follow-ups at weeks 1, 2, 4,6, 8, and 10 using a tele-conferencing program and the Hudl Technique application. At each tele-health video follow-up participants will be emailed a questionnaire assessing their progress and function. At month 6 a final data collection session to include video analysis will be performed.

03

Conditions studied

  • Knee Injuries

Browse trials for

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Pain free walking 2 miles in 35 minutes
  2. Weight bearing dorsiflexion (WBDF) Range of Motion (ROM) 80% symmetry
  3. 20 unassisted single leg heel raises
  4. Recovering from a lower-extremity injury

Exclusion criteria

Exclusion Criteria:

  1. History of previous stress fracture / fracture of the foot
  2. Participant who already uses a non-rearfoot strike running pattern
  3. Participant is pregnant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Intervention group

    The experimental group will have no in person education by researchers. All education and running modification will be performed via video. Education on running form, a home exercise program, and a 4 week return to run program will be provided to the subjects through e-mail. They will also receive the same in person video analysis performed at weeks 0 (initial), 10 and 6 months to assess running kinematics.

    Other: Intervention group

  • Active comparator
    Control group

    This group will have the same 4 week return to run program, home exercise program, and video analysis performed at weeks 0 (initial), 10 and 6 months to assess running kinematics.

    Other: Control group

Interventions

  • OtherControl group

    Control group runners will receive the same graduated return to run intervals and 4-week home exercise program. However, they will receive no video education during the initial 10 weeks.

  • OtherIntervention group

    Runners randomized to the intervention group will receive additional video tele-health instruction on how to transition to a non-rearfoot strike (NRFS) running pattern. Runners in the intervention group will have additional tele-health follow-ups at weeks 1, 2, 4,6, 8, and 10 using a tele-conferencing program and the Hudl Technique application. At each tele-health video follow-up participants will be emailed a questionnaire assessing their progress and function. At month 6 a final data collection session to include video analysis will be performed.

06

What researchers measure

Primary outcomes

  1. Foot Strike Pattern

    Analyzed through slow motion camera on an instrumented treadmill.

    Time frame: 6 months

Secondary outcomes

  1. Perceived running pain

    Subjects will self evaluate running ease and efficiency through the Single Assessment Numeric Evaluation.

    Time frame: 6 months

  2. Perceived running effort

    Subjects will self evaluate running ease and efficiency through the University of Wisconsin Running Injury and Recovery Index.

    Time frame: 6 months

  3. Perceived effort of running

    Subjects will self evaluate running ease and efficiency through the Patient Specific Functional Scale.

    Time frame: 6 months

07

Study locations

1 site
  • Keller Army Community Hospital
    West Point, New York 10996, United States
08

References and documents

Individual participant data

Plan to share: No — The principal investigator will keep your research records. These records may be looked at by staff from the Keller Army Community Hospital Department of Clinical Investigation, the Keller Army Community Hospital (KACH) Institutional Review Board (IRB), the Army Clinical Investigation Regulatory Office (CIRO), the Department of Defense (DoD) Higher Level Review, and other government agencies as part of their duties. These duties include making sure that the research participants are protected. Your research records may be disclosed outside of the hospital, but in this case, you will be identified only by a unique code number. Information about the code will be kept in a secure location and access limited to authorized research study personnel. This research study meets the confidentiality requirements of the Health Insurance Portability and Accountability Act (HIPAA).

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2018 to primary completion in May 2019, 7 months.

Of 94 non-industry interventional studies with no phase under Knee Injuries, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 51. This study's 7 months is below that.

Counting every sponsor, half of 99 studies reached it within 20 months; a quarter within 8 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2018
First posted
Apr 3, 2018
StartActual
Oct 4, 2018
Primary completionActual
May 15, 2019
CompletionActual
May 15, 2019
Last update
May 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03486405
Lead sponsor
Keller Army Community Hospital
Responsible party
Kyle East (Major, United States Air Force, Keller Army Community Hospital) — Principal investigator
First posted
Apr 3, 2018
Start date
Oct 4, 2018
Primary completion
May 15, 2019
Completion
May 15, 2019
Last update
May 20, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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