The Effect of Wii Fit Rehabilitation in Patients With Chronic Ankle Instability a Randomized Control Study

January 22, 2024 updated by: Aya abd el hady abbas, Cairo University

The goal of this clinical trial is to investigate the effect of Wii Fit rehabilitation on risk of fall, balance, and functional limitation, in patients with chronic ankle instability ,The main question it aims to answer is:

Are there any effect of Wii Fit rehabilitation training on balance, functional limitation, and risk of falls in patients with chronic ankle instability? Participants will be asked to sign a written informed consent form before the study according to guidelines of ethical committee The first group control group: 30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises.

The second group experimental group: 30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Wii Fit is an effective virtual reality approach for balance training. This intervention requires less time per session compared to traditional physical therapy treatment. Moreover, it is user-friendly, engaging, cost-effective and can be delivered at home without the need for supervision by a trained rehabilitation professional. Given the growing popularity of the technological approach as Wii Fit intervention, it would be important for the rehabilitation field to replicate these findings as high quality randomized clinical trials with large sample size and equal distribution of males and females.Further researches are needed to assess the long term effect of Wii training in patients with functional ankle instability. A variety of exercise programs were used as an intervention for chronic ankle instability, and conservative treatment interventions including balance, proprioceptive, and muscle strengthening exercises are effective for patients with chronic ankle instability

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Physical Therapy Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sixty patients, their age ranges between 18 to 60 years old.
  • Patients of both gender (men and women)
  • A history of at least one ankle sprain, with the initial sprain occurring more than 1-year before the study
  • A feeling of ''giving way'' at least 2 episodes in the last 6 months before the study
  • Experiencing a recurring sprain, which is defined as two or more sprains on the same ankle
  • No history of ankle injury within the three months prior to participation, and no cognitive deficit
  • Capability to perform the intervention or daily activities without an increase in pain
  • Currently they are not participating in any other rehabilitation exercise programs
  • No history of ankle surgery

Exclusion Criteria:

  • Subjects had balance deficits due to vestibular disorders, such as vertebro-basilar insufficiency and/or visual disorders
  • Tumors in the area to be treated for the study
  • pregnancy
  • Any injury or surgery done in ankle joint, deformity at lower extremity
  • Musculoskeletal condition like fracture, osteoporosis
  • Neurological condition like parkinsonism disease, ataxia, stroke, muscular dystrophy, myasthenia gravis
  • Cardiopulmonary conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional exercise training group
30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises.
Other: Strengthening, proprioceptive exercises.

-Strengthening exercise: Ankle Dorsiflexion and Plantar Flexion & inversion and eversion Strengthening with Exercise Bands

-Proprioceptive exercise using wobble board

Other Names:
  • conventional physical therapy training
Experimental: Wii Fit rehabilitation training group
30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training (strengthening, proprioceptive exercises)
Other: Strengthening, proprioceptive exercises.

-Strengthening exercise: Ankle Dorsiflexion and Plantar Flexion & inversion and eversion Strengthening with Exercise Bands

-Proprioceptive exercise using wobble board

Other Names:
  • conventional physical therapy training
Device: Wii fit
Nintendo Wii console (Nintendo Co., Ltd, Kyoto, Japan) is the main power unit of Nintendo Wii Fit. Its software includes an interactive video games that is played with a handheld, wireless remote that senses motion and requires the participant to mimic the action of their on - screen character. These games are played using a special Wii balance board in order to perform activities like yoga, balance and aerobics. The Wii remote is the primary controller for Nintendo's Wii console. The motion sensing capability is the main feature of it. It allows the user to interact with and manipulate items on screen via pointing.
Other Names:
  • Nintendo Wii Fit system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: "up to 8 weeks"
will be assessed by Biodex balance system (overall, Anterior posterior and mediolateral balance indices with opened eyes and closed eyes).
"up to 8 weeks"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional limitation
Time Frame: "up to 8 weeks"
will be assessed by Arabic version of the Foot and Ankle Ability Measure (FAAM). The FAAM consists of a 21-item Activities of Daily Living (ADL) scale and an 8- item Sports scale
"up to 8 weeks"

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of fall
Time Frame: "up to 8 weeks"
will be assessed by the Arabic Version of the Falls Efficacy Scale questionnaire
"up to 8 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: maher Ahmed el kablawy, Professor, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 8, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • clinical trial (Registry Identifier: Minia University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

NO individual participant data will be shared. Results will be published by the investigators in academic journal.

sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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