Ankle SprainNCT01134653
A Comparison of Early Mobilization Versus Traditional Treatment for Acute Ankle Sprains.
A study testing Jump Stretch in people with Ankle Sprain, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Jump Stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 3 day post injury
Who cannot join
- fracture
- chronic sprain
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43221
About this study
Official title: 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.
- Conditions
- Ankle Sprain
- Being tested
- Jump Stretch
- Keywords
- Acute ankle sprain in children and young adults
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jump StretchOther
distraction with early mobilization
| Study group | Role | What they receive |
|---|---|---|
| Jump stretch | Experimental | Distraction with early mobilization Receives: 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. Receives: Other: Jump Stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
days until return to activities
days until return to activities
Measured: discharge
Secondary outcomes (3)
VAS scale
scale to measure pain 1 week post enrollment
Measured: 1 week
strength
change in strength
Measured: 1 week
Figure of Eight Measurement
change in size of ankle in figure 8 measurement to swelling
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Alfano, Nationwide Children's Hospital
- Investigators
- Linda p Lowes, PhD, Principal investigator, columbus cri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134653
- Sponsor's protocol ID
- IRB07-00110
- Other IDs
- 663110
- Status last verified
- Feb 2025
- First submitted
- 28 May 2010
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Stretch Band Ankle Traction Technique in the Treatment of Acute Ankle Sprains.
- ClinicalTrials.gov ID
- NCT01134653
- Acronym / sponsor ID
- IRB07-00110
- Conditions
- Ankle Sprain
- Keywords
- Acute ankle sprain in children and young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jump stretch | Experimental | Other: Jump StretchDistraction with early mobilization |
| RICE | Active comparator | Other: Jump StretchSubject 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. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 3 day post injury
Key exclusion criteria (2 listed)
- fracture
- chronic sprain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jump Stretchdistraction with early mobilization | Other | Jump stretch, RICE |
Primary outcome
days until return to activities
Time frame: discharge
days until return to activities
3 secondary outcomes
VAS scale
Time frame: 1 week
strength
Time frame: 1 week
Figure of Eight Measurement
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda p Lowes, PhD principal investigator
columbus cri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jump Stretch in people with Ankle Sprain, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
days until return to activities (time frame: discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.