An interventional study of Wii fit and Strengthening, proprioceptive exercises. in Instability, Joint, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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
115 studies on the registry are indexed under Joint Instability; 21 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 58 interventional studies indexed under Joint Instability.
Browse Joint Instability studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
30 patients will receive conventional physical therapy training only which consist of strengthening, proprioceptive exercises.
Other: Strengthening, proprioceptive exercises.
30 patients Wii Fit group will receive Wii Fit rehabilitation training and the same conventional exercise training (strengthening, proprioceptive exercises)
Device: Wii fit · Other: Strengthening, proprioceptive exercises.
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.
Also known as: Nintendo Wii Fit system
-Strengthening exercise: Ankle Dorsiflexion and Plantar Flexion \& inversion and eversion Strengthening with Exercise Bands -Proprioceptive exercise using wobble board
Also known as: conventional physical therapy training
Balance
will be assessed by Biodex balance system (overall, Anterior posterior and mediolateral balance indices with opened eyes and closed eyes).
Time frame: "up to 8 weeks"
Functional limitation
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
Time frame: "up to 8 weeks"
Risk of fall
will be assessed by the Arabic Version of the Falls Efficacy Scale questionnaire
Time frame: "up to 8 weeks"
Plan to share: No — 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
Started Aug 2023 (actual). Primary completion is estimated for Nov 2024, 15 months after the start.
Of 36 non-industry interventional studies with no phase under Joint Instability, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's planned 15 months is close to that.
Counting every sponsor, half of 41 studies reached it within 15 months; a quarter within 7 and three quarters within 60.
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