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Ankle Sprain Rehabilitation With the Wii Balance Board

Primary Purpose

Ankle Sprain

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Physical Therapy
Wii Balance Board
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring Ankle sprain, Balance, Gait

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals Geneva

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

No treatment

Physical Therapy

Wii Balance group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2011
Last Updated
December 21, 2020
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT01449760
Brief Title
Ankle Sprain Rehabilitation With the Wii Balance Board
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Ankle sprain, Balance, Gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No treatment
Arm Type
No Intervention
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Title
Wii Balance group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Other Intervention Name(s)
physiotherapy
Intervention Description
These patients have a standardized conventional therapy (i.e. 9 sessions of physical therapy over 6 weeks)
Intervention Type
Other
Intervention Name(s)
Wii Balance Board
Intervention Description
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 Outcome Measure Information:
Title
Change in the balance performance(COP displacement in ML and AP direction)
Description
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
Time Frame
6 Weeks after the ankle sprain occured, after treatment (6 weeks) and in a 6 month follow up
Secondary Outcome Measure Information:
Title
Change in several functional parameters
Description
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
Time Frame
6 weeks after ankle sprain, after treatment (6 weeks) and 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University Hospitals Geneva
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

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Ankle Sprain Rehabilitation With the Wii Balance Board

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