SMART Intervention for Ankle Sprain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
William Beaumont Army Medical Center, El Paso, TXAnkle SprainSMART Intervention - Other
Eligibility
18 - 44
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Ankle Sprain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

15 Primary · 0 Secondary · Reporting Duration: rehabilitation discharge visit, 6 and 12 months post-discharge

12 months
Ankle re-injury rate
Month 12
Ankle
Change in Ankle cartilage relaxation
Change in Spinal Excitability
Change in White Mater Structural Integrity
Change in ankle dorsiflexion Range of Motion
Change in corticomotor Excitability - Active Motor Threshold
Change in corticomotor Excitability - Cortical Silent Period
Change in dynamic balance
Change in mental quality of life
Change in physical activity
Change in physical quality of life
Change in self-reported Ankle Disability
Change in self-reported Ankle Instability
Change in self-reported Functional Ankle Instability

Trial Safety

Trial Design

2 Treatment Groups

Standard of Care Intervention
1 of 2
SMART Intervention
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: SMART Intervention · No Placebo Group · N/A

SMART Intervention
Other
Experimental Group · 1 Intervention: SMART Intervention · Intervention Types: Other
Standard of Care Intervention
Other
ActiveComparator Group · 1 Intervention: Standard of Care Intervention · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: rehabilitation discharge visit, 6 and 12 months post-discharge

Who is running the clinical trial?

Phillip GribbleLead Sponsor
United States Department of DefenseFED
792 Previous Clinical Trials
213,143 Total Patients Enrolled
Phillip Gribble, PhDPrincipal Investigator - University of Kentucky
University of Kentucky

Eligibility Criteria

Age 18 - 44 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are beginning rehabilitation for a first-time, mild to moderate ankle sprain.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.