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

NCT01134653 | Completed

• 2 other identifiers: IRB07-00110663110
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Sprain

Keywords

Acute ankle sprain in children and young adults

Outcome Measures

Primary Outcomes (1)

• days until return to activities

  days until return to activities

  discharge

Secondary Outcomes (3)

• VAS scale

  1 week

• strength

  1 week

• Figure of Eight Measurement

  1 week

Study Arms (2)

Jump stretch

EXPERIMENTAL

Distraction with early mobilization

Other: Jump Stretch

RICE

ACTIVE COMPARATOR

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

Interventions

Jump Stretch OTHER

distraction with early mobilization

Jump stretch; RICE

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• day post injury

You may not qualify if:

• fracture
• chronic sprain

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Linda p Lowes, PhD

  columbus cri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

US (1)