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A Randomized Control Trial: Returning to Run After Injury

Primary Purpose

Knee Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control group
Intervention group
Sponsored by
Keller Army Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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:

  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

Sites / Locations

  • Keller Army Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Foot Strike Pattern
Analyzed through slow motion camera on an instrumented treadmill.

Secondary Outcome Measures

Perceived running pain
Subjects will self evaluate running ease and efficiency through the Single Assessment Numeric Evaluation.
Perceived running effort
Subjects will self evaluate running ease and efficiency through the University of Wisconsin Running Injury and Recovery Index.
Perceived effort of running
Subjects will self evaluate running ease and efficiency through the Patient Specific Functional Scale.

Full Information

First Posted
February 7, 2018
Last Updated
May 17, 2019
Sponsor
Keller Army Community Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03486405
Brief Title
A Randomized Control Trial: Returning to Run After Injury
Official Title
A Randomized Control Trial: Returning to Run After Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keller Army Community Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study will be a randomized control trial crossover design.
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot Strike Pattern
Description
Analyzed through slow motion camera on an instrumented treadmill.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Perceived running pain
Description
Subjects will self evaluate running ease and efficiency through the Single Assessment Numeric Evaluation.
Time Frame
6 months
Title
Perceived running effort
Description
Subjects will self evaluate running ease and efficiency through the University of Wisconsin Running Injury and Recovery Index.
Time Frame
6 months
Title
Perceived effort of running
Description
Subjects will self evaluate running ease and efficiency through the Patient Specific Functional Scale.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pain free walking 2 miles in 35 minutes Weight bearing dorsiflexion (WBDF) Range of Motion (ROM) 80% symmetry 20 unassisted single leg heel raises Recovering from a lower-extremity injury Exclusion Criteria: History of previous stress fracture / fracture of the foot Participant who already uses a non-rearfoot strike running pattern Participant is pregnant
Facility Information:
Facility Name
Keller Army Community Hospital
City
West Point
State/Province
New York
ZIP/Postal Code
10996
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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).

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A Randomized Control Trial: Returning to Run After Injury

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