- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01449760
Ankle Sprain Rehabilitation With the Wii Balance Board
Physical activity and in particular sport is beneficial to health. Nevertheless, some of these activities may create a risk of injury. Ankle sprain is the most common sport related injury. Sports that are causing the highest number of ankle sprains are: football (30%), handball-basketball-volleyball-rugby (24%), gymnastics sports (6%), skiing (6%), cycling (6%), athletics (4%) and contact sports (4%). A recent study in the Netherlands identified a total of 1.3 million sports injuries. 47% of these patients required medical care. The total costs (direct and indirect) were assessed 84.240.000 EUR per year.
Prospective studies demonstrated that athletes with a ankle sprain have a twofold risk of re-injury during the first year after the trauma, and in half of patients with an ankle sprain recurrence this could lead to instability or chronic pain of the ankle.
The Wii Balance Board ® is a tool that is increasingly used in the field of health. In some hospitals, therapists are beginning to use it for the rehabilitation of patients after surgery, fractures or strokes.
Patients are asked to complete their physical therapy session by practicing "sports" via video games such as skiing, bowling or hula hoop. Currently, there are no randomized controlled studies that publish on the effectiveness of this tool. Recently, a study investigated the efficacy of the Wii Balance Board ® to improve balance, strength, joint mobility and level of physical activity. After 10 weeks of training, people an increased strength and balance was found. However, these results still require statistical confirmation. Thus this objectives of this study are
- To assess the efficacy of exercise training with the Wii Balance Board ® Platform
- To evaluate the effectiveness of physical therapy (based on current guidelines)
- To compare these two types of care (conventional physiotherapy versus Wii) to a control group (non-treatment).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Geneva, Switzerland
- University Hospitals Geneva
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with an ankle sprain (grad 1 or 2), between 18 and 65 years old,
Exclusion Criteria:
- The subjects will not be included in the study if they are under 18 years
- They have other neurological or orthopedic disorders
- If taking medications (other than analgesics +/- NSAIDs prescribed during a sprain) that may influence the measurements.
- The patients with recurrent sprain of the ankle which was less than 12 months or who require surgery were also excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: No treatment
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Active Comparator: Physical Therapy
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These patients have a standardized conventional therapy (i.e. 9 sessions of physical therapy over 6 weeks)
Other Names:
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Experimental: Wii Balance group
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These patients get an instruction about how to install and use the Wii Balance Board ®.
After the instruction they get the equipment for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the balance performance(COP displacement in ML and AP direction)
Time Frame: 6 Weeks after the ankle sprain occured, after treatment (6 weeks) and in a 6 month follow up
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Change in the range of COP displacement during a single leg stance of 30 sec Change in the velocity of COP displacement during a single leg stance of 30 sec
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6 Weeks after the ankle sprain occured, after treatment (6 weeks) and in a 6 month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in several functional parameters
Time Frame: 6 weeks after ankle sprain, after treatment (6 weeks) and 6 month follow up
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6 weeks after ankle sprain, after treatment (6 weeks) and 6 month follow up
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09_116
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.
Clinical Trials on Ankle Sprain
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University of LahoreCompletedAnkle Sprain 1St Degree | Ankle Sprain 2Nd Degree | Lateral Ankle SprainPakistan
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Decathlon SEEFOR, FranceTerminatedAnkle Sprain 1St Degree | Ankle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeFrance
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Université Catholique de LouvainCompletedAnkle Sprain 1St Degree | Ankle Sprain 2Nd DegreeBelgium
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Instituto Mexicano del Seguro SocialCompletedAnkle Sprain | Ankle Sprain 1St Degree | Ankle Sprain 2Nd DegreeMexico
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Université Catholique de LouvainUZ Leuven, campus Pellenberg (Belgium)CompletedChronic Ankle Instability | Lateral Ankle SprainBelgium
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