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SMART Rehabilitation for Ankle Injury

N/A
Recruiting
Led By Phillip Gribble, PhD
Research Sponsored by Phillip Gribble
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up rehabilitation discharge visit, 6 and 12 months post-discharge
Awards & highlights

Study Summary

This trial will compare a new rehabilitation protocol for lateral ankle sprains against the current standard of care to see if it produces better one-year outcomes in terms of re-injury and health.

Who is the study for?
This trial is for individuals starting rehabilitation for a first-time acute grade I, II, or III lateral ankle sprain (LAS) that occurred within the last 72 hours. Participants must be diagnosed by an appropriate healthcare provider. Those with epilepsy, metal implants in the head (excluding dental), major psychiatric disorders, heart disease, cochlear implants, drug abuse history or certain medical conditions are excluded.Check my eligibility
What is being tested?
The study compares a new sensorimotor ankle rehabilitation training (SMART) protocol against standard care to see if it's better at preventing re-injury and improving health over one year after an LAS. Success will be measured using clinical outcomes and innovative markers.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects from physical therapy interventions like SMART may include temporary increased pain or discomfort during exercises and potential muscle soreness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~rehabilitation discharge visit, 6 and 12 months post-discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and rehabilitation discharge visit, 6 and 12 months post-discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ankle re-injury rate
Ankle
Change in Ankle cartilage relaxation
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SMART InterventionExperimental Treatment1 Intervention
The SMART intervention will utilize the elements of the Standard of Care intervention, and will also include "Sensorimotor Improvements" and other specific additions that will focus on sensory inputs, motor outputs, and integration of the sensory and motor pathways.
Group II: Standard of Care InterventionActive Control1 Intervention
The Standard of Care intervention will include restoration of ankle joint range of motion, strength and functional movement.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
858 Previous Clinical Trials
225,471 Total Patients Enrolled
Phillip GribbleLead Sponsor
Phillip Gribble, PhDPrincipal Investigator - University of Kentucky
University of Kentucky

Media Library

SMART Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03663361 — N/A
Ankle Sprain Research Study Groups: SMART Intervention, Standard of Care Intervention
Ankle Sprain Clinical Trial 2023: SMART Intervention Highlights & Side Effects. Trial Name: NCT03663361 — N/A
SMART Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03663361 — N/A
Ankle Sprain Patient Testimony for trial: Trial Name: NCT03663361 — N/A

Frequently Asked Questions

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

Are recruitment efforts ongoing for this medical experiment?

"The information hosted on clinicaltrials.gov indicates that this experiment is actively searching for participants, having first been posted in November 2019 and most recently updated in March 2022."

Answered by AI

Am I eligible to join this experimentation?

"Prospective applicants must possess a diagnosis of ankle sprain and fit within the 18-44 age range to be eligible for this medical trial. Currently, around 150 individuals have been accepted into the program."

Answered by AI

What is the current number of individuals enrolled in this clinical experiment?

"Affirmative. Per the clinicaltrials.gov database, this medical trial was first advertised on November 12th 2019 and is currently in search of 150 participants to be recruited from 3 sites. The official listing has been recently updated as well, with its last refresh occuring on March 4th 2022."

Answered by AI

Does this research project extend to individuals of advanced age?

"Only those between 18 and 44 years old can be accepted into this trial. There are 4 trials available for younger persons, while seniors aged 65 or older have 19 different options to choose from."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
William Beaumont Army Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Suffered open fracture to left ankle and easily rolls or miss steps.
PatientReceived no prior treatments
~42 spots leftby Dec 2025