Clinical trial NCT05957965: The Effect of Wii Fit Rehabilitation in Patients With Chronic Ankle Instability a Randomized Control Study
Official title: The Effect of Wii Fit Rehabilitation in Patients With Chronic Ankle Instability a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Instability, Joint
Keywords: Wii fit rehabilitation
chronic ankle instability
biodex balance system
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Balance
timeFrame: "up to 8 weeks"
Secondary outcomes:
measure: Functional limitation
timeFrame: "up to 8 weeks"
Other outcomes:
measure: Risk of fall
timeFrame: "up to 8 weeks"
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy Cairo University
Study officials:
affiliation: Cairo University
name: maher Ahmed el kablawy, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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