A Comparison of Early Mobilization Versus Traditional Treatment for Acute Ankle Sprains.

February 10, 2025 updated by: Lindsay Alfano, Nationwide Children's Hospital

Efficacy of Stretch Band Ankle Traction Technique in the Treatment of Acute Ankle Sprains.

Acute ankle sprain is one of the most common musculoskeletal injuries, accounting for an estimated 2 million injuries per year and 20% of all sports injuries in the United States. Ankle sprains can lead to prolonged periods of pain, difficulty with mobility, and lost work or play time. Current best practice guidelines for treatment of an acute ankle sprain are protection, rest, ice, compression and elevation (PRICE). However recent systematic reviews for ankle sprains call into question this treatment. Two critical components; immobilization and ice, have little or no evidence of efficacy for ankle sprain. Interestingly, mobilization appears to be more effective at reducing the pain, swelling and stiffness of musculoskeletal injuries including ankle sprains. Historically the limitation to early mobilization has been pain. Recently developed stretch bands have been introduced to the therapy market as a tool that allows pain-free active and resisted ankle movement after acute ankle sprain.

The investigators propose a double blind randomized controlled study to compare 2 ankle sprain treatments on their ability to speed recovery and reduce morbidities such as pain, swelling and weakness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 3 day post injury

Exclusion Criteria:

  • fracture
  • chronic sprain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jump stretch
Distraction with early mobilization
Other: Jump Stretch
distraction with early mobilization
Active Comparator: RICE
Subject receive standard ankle sprain treatment of Rest Ice compression and elevation for one week. This is followed by traditional strength and range of motion therapy. The subject does not receive distraction treatments.
Other: Jump Stretch
distraction with early mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
days until return to activities
Time Frame: discharge
days until return to activities
discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS scale
Time Frame: 1 week
scale to measure pain 1 week post enrollment
1 week
strength
Time Frame: 1 week
change in strength
1 week
Figure of Eight Measurement
Time Frame: 1 week
change in size of ankle in figure 8 measurement to swelling
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Linda p Lowes, PhD, columbus cri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimated)

June 2, 2010

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB07-00110
  • 663110 (Other Grant/Funding Number: Foundation for Physical Therapy)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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