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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01449760
Other study ID # 09_116
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2010
Est. completion date April 2015

Study information

Verified date December 2020
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Physical Therapy
These patients have a standardized conventional therapy (i.e. 9 sessions of physical therapy over 6 weeks)
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.

Locations

Country Name City State
Switzerland University Hospitals Geneva Geneva

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the balance performance(COP displacement in ML and AP direction) 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 6 Weeks after the ankle sprain occured, after treatment (6 weeks) and in a 6 month follow up
Secondary Change in several functional parameters pain (VAS)
delay in return to work
delay in return to sport
passive joint mobility of the ankle in flexion and extension
isometric strength of the inverters and evertors, plantar and dorsal flexors
functional ankle instability evaluated with FAAM questionnaire
gait parameters (kinematics and electromyographic activity of peroneus, gastrocnemius and tibialis anterior)
performance during a forwrd jump "monopodal": distance and time to stabilize the ankle
incidence of recurrent sprains side: 12-month prospective follow-up
6 weeks after ankle sprain, after treatment (6 weeks) and 6 month follow up
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