Actively Recruiting

Phase Not Applicable
Age: 18Years - 49Years
All Genders
ID04999904

A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability

Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2025-07-18

312

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

H

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

U

United States Naval Medical Center, San Diego

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating a new approach to improve rehabilitation outcomes for patients with ankle instability, particularly among those who have experienced ankle sprains. This trial compares standard physical therapy alone to physical therapy combined with training on a rocky, uneven terrain treadmill, aiming to better prepare patients for real-world challenges and reduce the risk of future ankle injuries. The study will include adults aged 18 to 49 who have chronic ankle instability or recent ankle sprains. Participants will be randomly assigned to one of two groups: one receiving up to twelve sessions of progressive proprioceptive training on an uneven treadmill over about six weeks plus standard physical therapy, and the other receiving only standard physical therapy for the same period. The uneven treadmill activities may include varied walking speeds, inclines, head turning, vision challenges, multitasking, and load carrying, all adjusted by therapists based on individual tolerance and benefit. Both groups will be followed for 18 months to monitor progress and reinjury. Throughout the study, participants will undergo multiple assessments, including patient-reported outcome tools like the Cumberland Ankle Instability Tool and Foot and Ankle Ability Measure, as well as performance tests and biomechanical evaluations such as muscle activation and plantar pressure measurements. These evaluations will occur at baseline, during treatment, at discharge around six weeks, and at several follow-up points up to 18 months. Researchers will track ankle function, physical activity levels, pain, fear of movement, and reinjury rates to understand the effects of the interventions.

CONDITIONS

Brief Title

A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability

Who Can Participate

Age: 18Years - 49Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 49 years
  • Score less than 24 on the Cumberland Ankle Instability Tool
  • Foot and Ankle Ability Measure Activities of Daily Living score 90 or less and Sports score 80 or less
  • Ability to attend treatment sessions for about six weeks
  • Passed most recent physical fitness test (for active duty only)
  • For acute lateral ankle sprain: first-time ankle sprain causing activity limitation for at least one day, injury occurred 2-6 weeks before consent
  • For chronic ankle instability: at least one significant ankle sprain in past 12 months with activity interruption, most recent sprain 2-12 weeks ago, history of ankle "giving way" or recurrent sprain or feelings of instability
  • Ready to start care with physical therapy
Not Eligible

You will not qualify if you...

  • Unable to walk at study enrollment
  • Non-removable casting
  • Previous surgeries on bones, joints, or nerves of lower limbs
  • History of fracture in lower limbs requiring realignment
  • Acute injury to other lower limb joints within past three months causing at least one day of activity interruption
  • Pregnancy
  • Disability from neuromuscular, neurological, or vestibular impairments affecting balance
  • Connective tissue disorders such as Marfan Syndrome or Ehlers-Danlos syndrome
  • Pending separation from military within 12 months due to medical or legal reasons

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 weeks

Participants receive standard of care physical therapy over approximately six weeks. Participants in the experimental group also receive up to twelve sessions of proprioceptive training on an uneven terrain treadmill during this period.

Up to 12 training sessions plus physical therapy visits over 6 weeks

Follow-up

Duration - 18 months

Participants are monitored for ankle function and reinjury status through patient-reported outcomes and performance measures.

Assessments at 3, 6, 9, 12, 15, and 18 months

Trial Site Locations

Total: 2 locations

1

Naval Hospital Camp Pendelton

Oceanside, California, United States, 92055

Actively Recruiting

2

Naval Medical Center San Diego

San Diego, California, United States, 92134

Actively Recruiting

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Research Team

P

Pinata Sessoms, PhD

S

Sara Gorczynski, PT DPT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Uneven Treadmill Training for Rehabilitation of Lateral Ankle Sprains and Chronic Ankle Instability: Protocol for a Pragmatic Randomized Controlled Trial.

Elizabeth Russell Esposito, Shawn Farrokhi, Benjamin R Shuman...

https://pubmed.ncbi.nlm.nih.gov/35731551