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Telehealth Rehabilitation for Ankle Sprains

N/A
Recruiting
Led By Kyle Kosik, Ph.D.
Research Sponsored by Kyle Kosik
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women between 15-35 years of age
Be younger than 65 years old
Must not have
Diagnosed with a concomitant injury (e.g., fracture)
Do not speak English.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 24-72 hours immediately post intervention at 1 month follow-up.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a 2-week telehealth intervention can help improve ankle function compared to usual care (pain medication and no physical rehabilitation).

Who is the study for?
This trial is for men and women aged 15-35 who've been diagnosed with a mild to moderate acute lateral ankle sprain in the last 72 hours, haven't had recent lower extremity surgery or injuries affecting balance and gait, speak English, and have not received physical therapy referrals.
What is being tested?
The study compares usual care with a new telehealth protocol over two weeks. It aims to see if the telehealth approach improves function, reduces pain and medication use, enhances balance and range of motion, while also assessing patient-perceived barriers.
What are the potential side effects?
Since this trial involves non-drug interventions like physical rehabilitation via telehealth versus usual care practices, side effects are minimal but may include discomfort from exercise or technical issues related to using telehealth services.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 15 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with another injury, like a fracture.
Select...
I do not speak English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 24-72 hours immediately post intervention and change from immediately post intervention at 1 month.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 24-72 hours immediately post intervention and change from immediately post intervention at 1 month. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of Intervention Measure (AIM)
Change in Feasibility of Intervention Measure (FIM)
Change in Foot and Ankle Ability Measure (FAAM)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 2-week Telehealth ProtocolExperimental Treatment1 Intervention
Participants randomized to this arm will receive 5 live-video sessions. The first 2 live-video sessions will occur during the first week, last 20 minutes each and separated by 48-72 hours. The last 3 live-video sessions will occur during the second week, last 30-minutes each and separated by 24-48 hours.
Group II: 2-week Usual CareActive Control1 Intervention
The usual care group will be used to reflect the current care provided to patients after discharged from the emergency department for an ankle sprain.

Find a Location

Who is running the clinical trial?

Kyle KosikLead Sponsor
Kyle Kosik, Ph.D.Principal Investigator - University of Kentucky
University of Kentucky

Media Library

Telehealth Delivered Physical Rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT04520854 — N/A
Acute Pain Research Study Groups: 2-week Telehealth Protocol, 2-week Usual Care
Acute Pain Clinical Trial 2023: Telehealth Delivered Physical Rehabilitation Highlights & Side Effects. Trial Name: NCT04520854 — N/A
Telehealth Delivered Physical Rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04520854 — N/A
~9 spots leftby Jun 2025