Ankle Sprain Rehabilitation With the Wii Balance Board

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lara Allet, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01449760
First received: October 5, 2011
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

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).

Condition Intervention
Ankle Sprain
Other: Physical Therapy
Other: Wii Balance Board

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change in several functional parameters [ Time Frame: 6 weeks after ankle sprain, after treatment (6 weeks) and 6 month follow up ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 300
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No treatment
Active Comparator: Physical Therapy Other: Physical Therapy
These patients have a standardized conventional therapy (i.e. 9 sessions of physical therapy over 6 weeks)
Other Name: physiotherapy
Experimental: Wii Balance group Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449760

Contacts
Contact: Jean-Luc Ziltener, MD 0041 22 372 36 06 Jean-Luc.Ziltener@hcuge.ch

Locations
Switzerland
University Hospitals Geneva Recruiting
Geneva, Switzerland
Contact: Jean Luc Ziltener, MD         
Principal Investigator: Lara ALLET, PhD         
Sponsors and Collaborators
University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Lara Allet, Principle investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01449760     History of Changes
Other Study ID Numbers: 09_116
Study First Received: October 5, 2011
Last Updated: October 11, 2011
Health Authority: Switzerland: University Hopsital Geneva

Keywords provided by University Hospital, Geneva:
Ankle sprain
Balance
Gait

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 28, 2014