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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from 24-72 hours immediately post intervention at 1 month follow-up.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 24-72 hours immediately post intervention and change from immediately post intervention at 1 month.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of Intervention Measure (AIM)

Change in Feasibility of Intervention Measure (FIM)

Change in Foot and Ankle Ability Measure (FAAM)

+8 more

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.

0 / 1Eligibility criteria met

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

Frequently Asked Questions

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

Is there still room for enrolment in this research endeavor?

"As recorded on clinicaltrials.gov, this medical investigation is seeking volunteers. It was initially advertised on January 1st 2021 and the most recent update dates back to September 26th 2022."

Answered by AI

How many subjects is the clinical trial accommodating?

"Affirmative, according to the data hosted on clinicaltrials.gov this medical trial is actively recruiting patients. This particular study was first posted on January 1st 2021 and last edited on September 26th 2022. 70 individuals will be accepted at one location for participation in the experiment."

Answered by AI

Does this experimentation accept elderly individuals as participants?

"This study is recruiting participants aged between 15 and 35 years old."

Answered by AI

Is it permissible for me to partake in this trial?

"This clinical trial is seeking to enrol 70 individuals aged between 15 and 35 who have recently experienced acute pain. The requisite criteria include: no recent ankle sprain within six months, any race or ethnicity, male or female gender, discharged from an ED within 72 hours of being diagnosed with a grade 1 or 2 lateral ankle sprain (LAS) without receiving physical therapy referral from their treating physician. To qualify as a LAS incident must entail inversion of the rearfoot along with combination of pain, swelling and time lost from activity for at least one day."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telehealth Delivered Physical Rehabilitation for an Ankle Sprain

Kyle Kosik 2021. "Telehealth Delivered Physical Rehabilitation for an Ankle Sprain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04520854.

All > Acute Pain