Trial Outcomes & Findings for Using Real Time Biofeedback to Alter Running Mechanics (NCT NCT02495792)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

191 participants

Primary outcome timeframe

Immediately post-training, 6mo post-training, and 1yr post-training

Results posted on

2024-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Group does not receive the biofeedback sensor	Biofeedback Group Group does receive the biofeedback sensor Biofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock
Overall Study STARTED	96	95
Overall Study COMPLETED	59	55
Overall Study NOT COMPLETED	37	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Group does not receive the biofeedback sensor	Biofeedback Group Group does receive the biofeedback sensor Biofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock
Overall Study Lost to Follow-up	5	9
Overall Study Protocol Violation	32	31

Baseline Characteristics

Using Real Time Biofeedback to Alter Running Mechanics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=59 Participants Group does not receive the biofeedback sensor	Biofeedback Group n=55 Participants Group does receive the biofeedback sensor Biofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock	Total n=114 Participants Total of all reporting groups
Age, Continuous	27.8 years STANDARD_DEVIATION 9.6 • n=5 Participants	25.7 years STANDARD_DEVIATION 9.1 • n=7 Participants	26.8 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants
Height	173.1 Centimeters STANDARD_DEVIATION 12.2 • n=5 Participants	174.9 Centimeters STANDARD_DEVIATION 8.3 • n=7 Participants	174 Centimeters STANDARD_DEVIATION 10.2 • n=5 Participants
Weight	74.3 Kilograms STANDARD_DEVIATION 12.4 • n=5 Participants	75.8 Kilograms STANDARD_DEVIATION 11.8 • n=7 Participants	75.1 Kilograms STANDARD_DEVIATION 12.1 • n=5 Participants
Weekly Mileage	23.7 Kilometers per Week STANDARD_DEVIATION 10.7 • n=5 Participants	22.9 Kilometers per Week STANDARD_DEVIATION 14 • n=7 Participants	23.3 Kilometers per Week STANDARD_DEVIATION 12.3 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=59 Participants Group does not receive the biofeedback sensor	Biofeedback Group n=55 Participants Group does receive the biofeedback sensor Biofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock
Change in Foot Strike Pattern From Baseline 1 year	69 percentage of non-rearfoot strike patter	75 percentage of non-rearfoot strike patter
Change in Foot Strike Pattern From Baseline Post-Training	79 percentage of non-rearfoot strike patter	83 percentage of non-rearfoot strike patter
Change in Foot Strike Pattern From Baseline 6 months	68 percentage of non-rearfoot strike patter	73 percentage of non-rearfoot strike patter

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=32 Participants Group does not receive the biofeedback sensor	Biofeedback Group n=82 Participants Group does receive the biofeedback sensor Biofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock
Injury Incidence Between Foot Strike Patterns	37 percentage of injured runners	30 percentage of injured runners

SECONDARY outcome

Timeframe: 1yr

Risk of runner to develop a knee injury based on foot-strike pattern

Outcome measures

Outcome measures
Measure	Control Group n=32 Participants Group does not receive the biofeedback sensor	Biofeedback Group n=82 Participants Group does receive the biofeedback sensor Biofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock
Relative Risk of Injury Developed knee pain	7 Participants	3 Participants
Relative Risk of Injury Did not develop knee pain	25 Participants	79 Participants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Biofeedback Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MAJ Jamie Morris

Brooke Army Medical Center

Phone: 210-221-3700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place