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

This study has been completed.
Information provided by (Responsible Party):
Linda Pax Lowes, Nationwide Children's Hospital Identifier:
First received: May 28, 2010
Last updated: February 2, 2015
Last verified: February 2015

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.

Condition Intervention
Ankle Sprain Other: Jump Stretch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Stretch Band Ankle Traction Technique in the Treatment of Acute Ankle Sprains.

Further study details as provided by Linda Pax Lowes, Nationwide Children's Hospital:

Primary Outcome Measures:
  • days until return to activities [ Time Frame: discharge ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 1 week ]
    VAS scale 1 week post enrollment

  • strength [ Time Frame: 1 week ]
    change in strength

  • swelling [ Time Frame: 1 week ]
    change in figure 8 measurement

Enrollment: 42
Study Start Date: January 2010
Study Completion Date: February 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 3 day post injury

Exclusion Criteria:

  • fracture
  • chronic sprain
  Contacts and Locations
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Please refer to this study by its identifier: NCT01134653

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Nationwide Children's Hospital
Principal Investigator: Linda p Lowes, PhD columbus cri
  More Information

Responsible Party: Linda Pax Lowes, Principal Investigator, Nationwide Children's Hospital Identifier: NCT01134653     History of Changes
Other Study ID Numbers: IRB07-00110
663110 ( Other Grant/Funding Number: Foundation for Physical Therapy )
Study First Received: May 28, 2010
Last Updated: February 2, 2015

Keywords provided by Linda Pax Lowes, Nationwide Children's Hospital:
Acute ankle sprain in children and young adults

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries processed this record on September 20, 2017