312 Participants Needed

Proprioceptive Training on Uneven Terrain Treadmill for Ankle Instability

(ROCKY REHAB Trial)

Recruiting at 1 trial location
ER
EC
PS
SG
Overseen BySara Gorczynski, PT DPT
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using a rocky, uneven treadmill during physical therapy can aid recovery and prevent future injuries in people with ankle instability. Participants will either use the uneven treadmill alongside regular physical therapy or continue with standard physical therapy, both over approximately six weeks. The trial seeks individuals who have experienced an ankle sprain in the last 2-12 weeks, feel ankle instability, and are beginning physical therapy. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation methods that could enhance recovery.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the uneven treadmill intervention is safe for patients with ankle instability?

Research has shown that using a treadmill with uneven surfaces in physical therapy is generally safe. In past studies, patients using these treadmills reported no serious side effects. This treatment imitates real-life walking conditions, which can help improve balance and strength for those with weak ankles. Although specific data on negative effects is lacking, the absence of reported problems suggests it is well-tolerated. Always consult your healthcare provider if you have any concerns during therapy.12345

Why are researchers excited about this trial?

Researchers are excited about the proprioceptive training on an uneven terrain treadmill for ankle instability because it introduces a unique challenge that could improve balance and stability more effectively than traditional methods. Unlike standard physical therapy, which often involves exercises on flat surfaces, this approach uses a treadmill with uneven terrain to mimic real-world conditions, potentially enhancing the body's ability to adapt and strengthen ankle support. This method aims to offer a more dynamic and functional rehabilitation experience, helping individuals regain confidence and reduce the risk of future injuries.

What evidence suggests that this trial's treatments could be effective for ankle instability?

Research shows that adding uneven treadmill training to regular ankle rehab can enhance recovery for those with ankle instability. In this trial, participants in the Uneven Treadmill Arm will receive the Uneven Treadmill Intervention alongside Standard of Care Physical Therapy. Studies have found that this method mimics walking on rocky, uneven surfaces, improving balance and strength. Early results suggest that patients using this type of treadmill may recover better and experience fewer re-injuries over time. The goal is to improve proprioception, the body's ability to sense its position and movement, leading to better stability. Overall, this approach appears promising for reducing ankle injuries and aiding recovery.12356

Who Is on the Research Team?

PS

Pinata Sessoms, PhD

Principal Investigator

Naval Health Research Center

Are You a Good Fit for This Trial?

This trial is for people aged 18-49 who've had a significant ankle sprain in the last year, causing them to stop their activities for at least one day. They should have ongoing ankle instability, no prior surgeries on leg bones or joints, and be able to attend physical therapy sessions for about six weeks.

Inclusion Criteria

Score < 24 on the Cumberland Ankle Instability Tool
I can attend treatment sessions for about 6 weeks.
Passed most recent physical fitness test (Active duty only)
See 2 more

Exclusion Criteria

I have had a fracture in my leg that needed to be realigned.
Non-removable casting
I have had surgery on my bones, joints, or nerves.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care physical therapy or the standard of care supplemented with the uneven treadmill intervention over approximately six weeks

6 weeks
Up to 12 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple intervals

18 months
Follow-up assessments at 3, 6, 9, 12, 15, and 18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Standard of Care Physical Therapy
  • Uneven Treadmill Intervention
Trial Overview The ROCKY REHAB trial tests if using an uneven terrain treadmill during physical therapy helps improve recovery and prevent future injuries in patients with unstable ankles compared to standard care physical therapy alone.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Uneven Treadmill ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials
103
Recruited
94,300+

Fort Sam Houston

Collaborator

Trials
2
Recruited
450+

Naval Hospital Camp Pendleton

Collaborator

Trials
5
Recruited
1,200+

Madigan Army Medical Center

Collaborator

Trials
52
Recruited
17,600+

Naval Health Research Center

Collaborator

Trials
21
Recruited
177,000+

Veterans Affairs Puget Sound Health Care System

Collaborator

Trials
1
Recruited
310+

VA Puget Sound Health Care System

Collaborator

Trials
67
Recruited
225,000+

Naval Hospital Camp Pendleton

Collaborator

Trials
6
Recruited
1,300+

Extremity Trauma and Amputation Center of Excellence

Collaborator

Trials
1
Recruited
310+

United States Naval Medical Center, San Diego

Collaborator

Trials
110
Recruited
24,200+

Citations

A Proprioceptive Training Program Using an Uneven ...Patient reported outcomes and reinjury rates will be tracked for 18 months. Official Title. A Proprioceptive Training Program Using an Uneven Terrain Treadmill ...
Uneven Treadmill Training for Rehabilitation of Lateral ...The aim of this study is to evaluate whether the inclusion of uneven treadmill training in standard rehabilitation can improve clinical, ...
A Proprioceptive Training Program Using an Uneven Terrain ...The proposed intervention uses a rocky uneven terrain treadmill that specifically targets aspects of the real-world environment to restore and improve short- ...
Uneven Treadmill Training for Rehabilitation of Lateral ...Objective: The aim of this study is to evaluate whether the inclusion of uneven treadmill training in standard rehabilitation can improve clinical, functional, ...
A Proprioceptive Training Program Using an Uneven Terrain ...The rocky treadmill replicates the rough, uneven terrain encountered by Service personnel and lends itself to incorporating a variety of ...
Patient-Reported Outcome Measures in Individuals With ...Chronic ankle instability (CAI) is most likely associated with decreased health-related quality of life as measured by patient-reported outcomes. Patient- ...
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