NCT01449760

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

5.1 years

First QC Date

October 5, 2011

Last Update Submit

December 21, 2020

Conditions

Keywords

Ankle sprainBalanceGait

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in several functional parameters

    6 weeks after ankle sprain, after treatment (6 weeks) and 6 month follow up

Study Arms (3)

No treatment

NO INTERVENTION

Physical Therapy

ACTIVE COMPARATOR
Other: Physical Therapy

Wii Balance group

EXPERIMENTAL
Other: Wii Balance Board

Interventions

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

Also known as: physiotherapy
Physical Therapy

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.

Wii Balance group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with an ankle sprain (grad 1 or 2), between 18 and 65 years old,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Geneva

Geneva, Switzerland

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 10, 2011

Study Start

March 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations