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Proprioceptive Training on Uneven Terrain Treadmill for Ankle Instability (ROCKY REHAB Trial)

N/A
Recruiting
Led By Elizabeth Russell Esposito, PhD
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute lateral ankle sprain specific inclusion criteria: history of a first-time ankle sprain that resulted in activity limitation that lasted at least one day, chronicity of 2-6 weeks prior to consent, Chronic ankle instability specific inclusion criteria: history of at least one significant ankle sprain within the 12 months prior to enrollment that interrupted physical activity for 1+ days, most recent ankle sprain in the past 2-8 weeks, history of the previously injured ankle joint 'giving way' and/or recurrent sprain and/or 'feelings of instability,' Individual is about to start care with physical therapy
Aged 18-49
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Awards & highlights

ROCKY REHAB Trial Summary

This trial will test if a rocky, uneven terrain treadmill can help improve outcomes and reduce reinjury rates for patients with ankle instability during physical therapy.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include increased soreness or pain due to the challenging nature of training on an uneven surface which could potentially lead to falls or further strain.

ROCKY REHAB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 49 years old.
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My ankle-foot condition significantly limits my daily and sports activities.

ROCKY REHAB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 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
Change in the Cumberland Ankle Instability Tool
Change in the Foot and Ankle Ability Measure, Activities of Daily Living Subscale
Change in the Foot and Ankle Ability Measure, Sports Subscale
Secondary outcome measures
Ankle Reinjury Status
Change in Electromyography (EMG)
Change in the Edgren Side Step Test
+8 more

ROCKY REHAB Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Uneven Treadmill ArmExperimental Treatment1 Intervention
Uneven Treadmill Intervention with up to twelve sessions over approximately six weeks and Standard of Care Physical Therapy with an 18 month follow-up period
Group II: Control ArmActive Control1 Intervention
Standard of Care Physical Therapy over approximately six weeks with an 18 month follow-up period

Find a Location

Who is running the clinical trial?

Fort Sam HoustonUNKNOWN
1 Previous Clinical Trials
140 Total Patients Enrolled
Naval Hospital Camp PendletonUNKNOWN
2 Previous Clinical Trials
287 Total Patients Enrolled
Madigan Army Medical CenterFED
48 Previous Clinical Trials
17,892 Total Patients Enrolled

Media Library

Standard of Care Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04999904 — N/A
Ankle Sprain Research Study Groups: Uneven Treadmill Arm, Control Arm
Ankle Sprain Clinical Trial 2023: Standard of Care Physical Therapy Highlights & Side Effects. Trial Name: NCT04999904 — N/A
Standard of Care Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04999904 — 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 additional places where participants can enroll in this research?

"Clinicaltrials.gov attests that this investigation into a new medication is actively seeking participants, with the study first posted on November 23rd 2021 and most recently updated March 30th 2022."

Answered by AI

How extensive is the population participating in this clinical trial?

"Indeed, clinicaltrials.gov confirms that the trial was initially posted on November 23rd 2021 and is actively recruiting patients. On this occasion, 312 participants are needed at 2 locations."

Answered by AI

Would I be eligible to become a participant in this research endeavor?

"To be eligible for this medical trial, patients must have a pre-existing ankle injury and display instability in the joint. The age range required is between 18 to 49 years old with 312 participants needed."

Answered by AI

What are the targeted outcomes of this research endeavor?

"The primary outcome of this trial will be assessed at baseline, two and four week intervals as well as six weeks post-treatment. It is the Change in Foot and Ankle Ability Measure, Activities of Daily Living Subscale. Additionally, the Edgren Side Step Test (measuring distance traversed in 10 seconds), The Tampa Scale of Kinesiophobia (11-item questionnaire with higher scores indicating greater kinesiophobia) ,and Y Balance Test (composite reach distance normalised by subject's leg length) are being used to assess secondary outcomes over 3 month, 6 months 9 months 12 months 15 months and 18 month periods"

Answered by AI

Does the age requirement for this trial extend beyond thirty-five years of age?

"The recruitment process of this trial limits the potential participants to those aged 18 and above, up until 49 years old."

Answered by AI
~94 spots leftby Mar 2025