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Speed Walking Program for Broken Bones (RIFLE Trial)

N/A
Recruiting
Led By Brian Noehren, Ph.D.
Research Sponsored by Brian W. Noehren
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute orthopedic injury to the femoral or tibial shaft requiring surgical fixation with an intramedullary rod
Age 18-50 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

RIFLE Trial Summary

This trial will study the effects of a speed-based HIIT walking program on patients who have recently undergone orthopedic trauma surgery.

Who is the study for?
This trial is for English-speaking adults aged 18-50 who've had a femur or tibia fracture fixed with a rod. They must have been working at least part-time before the injury and be able to attend follow-up visits and therapy sessions without an assistive walking device.Check my eligibility
What is being tested?
The study tests a high-intensity speed walking program against standard physical therapy for those recovering from leg fractures. It aims to see if this type of exercise can improve recovery outcomes after orthopedic trauma.See study design
What are the potential side effects?
Potential side effects may include muscle soreness, joint pain, or fatigue due to the intensity of the speed walking intervention compared to regular physical therapy.

RIFLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need surgery for a broken leg bone using a metal rod.
Select...
I am between 18 and 50 years old.

RIFLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self-reported physical function
Secondary outcome measures
60-second step down test
Fastest Walking Speed
Pain
+6 more
Other outcome measures
Lower Extremity

RIFLE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard of Care Physical Therapy Program with Speed Walking InterventionExperimental Treatment2 Interventions
Standard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits. Additionally, subjects will complete the speed walking intervention. Participants will perform at 2 minute warm up followed by 1 minute of walking at their fastest tolerable speed followed by 2 minutes of active recovery where they will walk at a speed of their choosing. The subjects will perform 4 cycles of this followed by a 2 minute cool down at the end.
Group II: Standard of Care Physical Therapy ProgramPlacebo Group1 Intervention
Standard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits.

Find a Location

Who is running the clinical trial?

U.S. Army Medical Research and Development CommandFED
285 Previous Clinical Trials
245,099 Total Patients Enrolled
Brian W. NoehrenLead Sponsor
1 Previous Clinical Trials
55 Total Patients Enrolled
Brian Noehren, Ph.D.Principal InvestigatorUniversity of Kentucky

Media Library

Speed Walking Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05274022 — N/A
Femur Fractures Research Study Groups: Standard of Care Physical Therapy Program with Speed Walking Intervention, Standard of Care Physical Therapy Program
Femur Fractures Clinical Trial 2023: Speed Walking Intervention Highlights & Side Effects. Trial Name: NCT05274022 — N/A
Speed Walking Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05274022 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participants to join this clinical experiment at the moment?

"Yes, according to the clinicaltrials.gov database this trial is still seeking subjects. Having been first posted on March 3rd 2022 with last alteration occurring on May 26th 2022, it requires 60 individuals from 2 distinct sites for participation in the study."

Answered by AI

Could you give me an estimate of the total number of participants enrolled in this clinical trial?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was initially published on March 3rd 2022, is currently seeking participants. Approximately 60 people need to be recruited from 2 separate medical centres."

Answered by AI

Would I be eligible to participate in this clinical experiment?

"For this trial, a total of 60 participants aged 18 to 50 who have recently sustained Segond fractures will be recruited. To qualify for the study all patients must meet the following criteria: proficiency in English language, an orthopedic injury to either femoral or tibial shaft requiring surgical intermedullary rod fixation and age between 18-50 years old."

Answered by AI

Does the age criteria for participation in this trial exceed 25 years old?

"Those wishing to take part in this medical trail must be between the ages of 18 and 50. For minors, there are 66 trials available while seniors have 296 options for clinical experimentation."

Answered by AI
~23 spots leftby Jul 2025