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

Not Applicable

Recruiting

• Conditions: Instability, Joint
• Interventions: Device: Wii fit; Other: Strengthening, proprioceptive exercises.

• Registration Number: NCT05957965
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-07-08
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-24
• Study Start: 2023-08-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wii Fit rehabilitation training group	Strengthening, proprioceptive exercises.	30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training (strengthening, proprioceptive exercises)
Wii Fit rehabilitation training group	Wii fit	30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training (strengthening, proprioceptive exercises)
Conventional exercise training group	Strengthening, proprioceptive exercises.	30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Functional limitation	"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

Trial Locations

Locations (1)

Faculty of Physical Therapy Cairo University; 🇪🇬 Cairo, Egypt