Healthy
Conditions
Brief summary
The purposes of this study are 1) to assess foot strike patterns initially, at six months and at one year between two groups of runners attempting to transition to a non-rearfoot strike pattern (NRFS) with and without the use of biofeedback technology, and 2) to prospectively compare injury incidence rates at one year between NRFS and rearfoot strike (RFS) runners.
Interventions
DEVICEBiofeedback Sensor
Tibia accelerometer strapped to distal tibia to detect tibial shock
Sponsors
Keller Army Community Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Between the age of 18 - 50 years 2. Run on average 12mi per week 3. DOD beneficiaries who intend to remain at West Point, NY for the next 12 months at time of study enrollment 4. Read and speak English well enough to provide informed consent and follow study instructions
Exclusion criteria
1. Known pregnancy currently or in the previous 6 months 2. Lower extremity or low back pain in the previous 3 months 3. Lower extremity or low back surgery in the previous 6 months 4. Any lower extremity or low back exercise limiting profile 5. Previous stress fracture of the foot 6. Participant who has a non-rearfoot strike running pattern
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Foot Strike Pattern From Baseline | Immediately post-training, 6mo post-training, and 1yr post-training | Foot strike pattern will be either classified as rearfoot strike or non-rearfoot strike. This is determined by video analysis of 240hz camera. All participants baseline foot strike pattern was rearfoot at study enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injury Incidence Between Foot Strike Patterns | 1yr | Percentage of runners that became injured over 1 yr. Injury defined as pain in the lower extremity that caused restriction or stoppage of running for at least one week, or required the runner to consult a physician or other health care professional. |
| Relative Risk of Injury | 1yr | Risk of runner to develop a knee injury based on foot-strike pattern |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Group does not receive the biofeedback sensor | 59 |
| Biofeedback Group Group does receive the biofeedback sensor
Biofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock | 55 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 9 |
| Overall Study | Protocol Violation | 32 | 31 |
Baseline characteristics
| Characteristic | Control Group | Biofeedback Group | Total |
|---|---|---|---|
| Age, Continuous | 27.8 years STANDARD_DEVIATION 9.6 | 25.7 years STANDARD_DEVIATION 9.1 | 26.8 years STANDARD_DEVIATION 9.4 |
| Height | 173.1 Centimeters STANDARD_DEVIATION 12.2 | 174.9 Centimeters STANDARD_DEVIATION 8.3 | 174 Centimeters STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 15 Participants | 11 Participants | 26 Participants |
| Sex: Female, Male Male | 44 Participants | 44 Participants | 88 Participants |
| Weekly Mileage | 23.7 Kilometers per Week STANDARD_DEVIATION 10.7 | 22.9 Kilometers per Week STANDARD_DEVIATION 14 | 23.3 Kilometers per Week STANDARD_DEVIATION 12.3 |
| Weight | 74.3 Kilograms STANDARD_DEVIATION 12.4 | 75.8 Kilograms STANDARD_DEVIATION 11.8 | 75.1 Kilograms STANDARD_DEVIATION 12.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 96 | 0 / 95 |
| serious Total, serious adverse events | 0 / 96 | 0 / 95 |
Outcome results
Primary
Change in Foot Strike Pattern From Baseline
Foot strike pattern will be either classified as rearfoot strike or non-rearfoot strike. This is determined by video analysis of 240hz camera. All participants baseline foot strike pattern was rearfoot at study enrollment.
Time frame: Immediately post-training, 6mo post-training, and 1yr post-training
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Change in Foot Strike Pattern From Baseline | Post-Training | 79 percentage of non-rearfoot strike patter |
| Control Group | Change in Foot Strike Pattern From Baseline | 6 months | 68 percentage of non-rearfoot strike patter |
| Control Group | Change in Foot Strike Pattern From Baseline | 1 year | 69 percentage of non-rearfoot strike patter |
| Biofeedback Group | Change in Foot Strike Pattern From Baseline | Post-Training | 83 percentage of non-rearfoot strike patter |
| Biofeedback Group | Change in Foot Strike Pattern From Baseline | 6 months | 73 percentage of non-rearfoot strike patter |
| Biofeedback Group | Change in Foot Strike Pattern From Baseline | 1 year | 75 percentage of non-rearfoot strike patter |
Secondary
Injury Incidence Between Foot Strike Patterns
Percentage of runners that became injured over 1 yr. Injury defined as pain in the lower extremity that caused restriction or stoppage of running for at least one week, or required the runner to consult a physician or other health care professional.
Time frame: 1yr
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Injury Incidence Between Foot Strike Patterns | 37 percentage of injured runners |
| Biofeedback Group | Injury Incidence Between Foot Strike Patterns | 30 percentage of injured runners |
Secondary
Relative Risk of Injury
Risk of runner to develop a knee injury based on foot-strike pattern
Time frame: 1yr
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Relative Risk of Injury | Developed knee pain | 7 Participants |
| Control Group | Relative Risk of Injury | Did not develop knee pain | 25 Participants |
| Biofeedback Group | Relative Risk of Injury | Developed knee pain | 3 Participants |
| Biofeedback Group | Relative Risk of Injury | Did not develop knee pain | 79 Participants |
95% CI: [1.6, 21.7]