Using Real Time Biofeedback to Alter Running Mechanics

NCT ID: NCT02495792

Last Updated: 2024-04-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Group does not receive the biofeedback sensor

Group Type NO_INTERVENTION

No interventions assigned to this group

Biofeedback group

Group does receive the biofeedback sensor

Group Type EXPERIMENTAL

Biofeedback Sensor

Intervention Type DEVICE

Tibia accelerometer strapped to distal tibia to detect tibial shock

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biofeedback Sensor

Tibia accelerometer strapped to distal tibia to detect tibial shock

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Keller Army Community Hospital

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jamie Morris

Physical Therapy Sports Medicine Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jamie B Morris, DPT

Role: PRINCIPAL_INVESTIGATOR

Keller Army Community Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

404239-2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Footwear and Injury Prevention Study
NCT00832195 COMPLETED PHASE3