A Comparison of Early Mobilization Versus Traditional Treatment for Acute Ankle Sprains.
Primary Purpose
Ankle Sprain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Jump Stretch
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Sprain focused on measuring Acute ankle sprain in children and young adults
Eligibility Criteria
Inclusion Criteria:
- 3 day post injury
Exclusion Criteria:
- fracture
- chronic sprain
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Jump stretch
RICE
Arm Description
Distraction with early mobilization
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.
Outcomes
Primary Outcome Measures
days until return to activities
days until return to activities
Secondary Outcome Measures
VAS scale
scale to measure pain 1 week post enrollment
strength
change in strength
Figure of Eight Measurement
change in size of ankle in figure 8 measurement to swelling
Full Information
NCT ID
NCT01134653
First Posted
May 28, 2010
Last Updated
June 11, 2019
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01134653
Brief Title
A Comparison of Early Mobilization Versus Traditional Treatment for Acute Ankle Sprains.
Official Title
Efficacy of Stretch Band Ankle Traction Technique in the Treatment of Acute Ankle Sprains.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Acute ankle sprain in children and young adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jump stretch
Arm Type
Experimental
Arm Description
Distraction with early mobilization
Arm Title
RICE
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Jump Stretch
Intervention Description
distraction with early mobilization
Primary Outcome Measure Information:
Title
days until return to activities
Description
days until return to activities
Time Frame
discharge
Secondary Outcome Measure Information:
Title
VAS scale
Description
scale to measure pain 1 week post enrollment
Time Frame
1 week
Title
strength
Description
change in strength
Time Frame
1 week
Title
Figure of Eight Measurement
Description
change in size of ankle in figure 8 measurement to swelling
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
3 day post injury
Exclusion Criteria:
fracture
chronic sprain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda p Lowes, PhD
Organizational Affiliation
columbus cri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Early Mobilization Versus Traditional Treatment for Acute Ankle Sprains.
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