Overview

This trial is active, not recruiting.

Condition ankle sprain
Treatments physical therapy, wii balance board
Sponsor University Hospital, Geneva
Start date March 2010
End date March 2015
Trial size 90 participants
Trial identifier NCT01449760, 09_116

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
(Active Comparator)
physical therapy physiotherapy
These patients have a standardized conventional therapy (i.e. 9 sessions of physical therapy over 6 weeks)
(Experimental)
wii balance board
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Change in several functional parameters
time frame: 6 weeks after ankle sprain, after treatment (6 weeks) and 6 month follow up

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Geneva.