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Study protocol of a randomized clinical trial evaluating the effectiveness of a primary care intervention using the Nintendo™ Wii console to improve balance and decrease falls in the elderly.

ABSTRACT: Balance alteration is a risk factor for falls in elderly individuals that has physical, psychological and economic consequences. The objectives of this study are to evaluate the usefulness of an intervention utilizing the Nintendo™ Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one foot stationary test.This is a controlled, randomized clinical trial of individual assignment, carried out on patients over 70 years in age, from five primary care centers in the city of Mataró (Barcelona). 380 patients were necessary for the intervention group that carried out the balance board exercises in 2 sessions per week for a 3 month period, and 380 patients in the control group who carried out their usual habits. Balance was evaluated using the Tinetti test, the one foot stationary test and with the console, at the start of the study, at the end of the intervention (3 months) and one year later. Quarterly telephone follow-up was also conducted to keep track of falls and their consequences.The study aimed to connect the community with a technology that may be an easy and fun way to assist the elderly in improving their balance without the need to leave home or join rehabilitation groups, offering greater comfort for this population and decreasing healthcare costs since there is no need for specialized personnel.Current Control Trial NCT02570178.

SUBMITTER: Montero-Alia P

PROVIDER: S-EPMC4722618 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Study protocol of a randomized clinical trial evaluating the effectiveness of a primary care intervention using the Nintendo™ Wii console to improve balance and decrease falls in the elderly.

Montero-Alía Pilar P Muñoz-Ortiz Laura L Jiménez-González Mercè M Jiménez-González Mercè M Benedicto-Pañell Carla C Altimir-Losada Salvador S López-Colomer Yolanda Y Prat-Rovira Josep J Amargant-Rubio Joan Francesc JF Jastes Sheila Mendes SM Moreno-Buitrago Ana A Rodríguez-Pérez M Carmen MC Teixidó-Vargas Cristina C Albarrán-Sánchez José Luís JL Candel-Gil Anna A Serra-Serra Domènec D Martí-Cervantes Juan José JJ Sánchez-Pérez Carlos Andrés CA Sañudo-Blanco Lidia L Dolader-Olivé Sònia S Torán-Monserrat Pere P

BMC geriatrics 20160112

<h4>Background</h4>Balance alteration is a risk factor for falls in elderly individuals that has physical, psychological and economic consequences. The objectives of this study are to evaluate the usefulness of an intervention utilizing the Nintendo™ Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one ...[more]

PMID: 26796956

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Project description:BACKGROUND:Frailty can be defined as a medical syndrome with multiple causes and contributors, characterized by diminished strength and endurance and reduced physiological function that increases the vulnerability to develop functional dependency and/or death. Studies have shown that the most commonly studied exercise protocol for frail older adults is the multimodal training. Interactive video games (IVGs) involve tasks in virtual environments that combine physical and cognitive demands in an attractive and challenging way. The aim of this study will be to evaluate the feasibility, safety, acceptability, and functional outcomes of playing Nintendo Wii Fit PlusTM (NWFP) for frail older adults. METHODS/DESIGN:The study is a randomized controlled, parallel group, feasibility trial. Participants will be randomly assigned to the experimental group (EG) and control group (CG). The EG will participate in 14 training sessions, each lasting 50 min, twice a week. In each training session, the participants will play five games, with three attempts at each game. The first attempt will be performed with the assistance of a physical therapist to correct the movements and posture of the patients and subsequent attempts will be performed independently. Scores achieved in the games will be recorded. The participants will be evaluated by a blinded physical therapist at three moments: before and after intervention and 30 days after the end of the intervention (follow-up). We will assess the feasibility, acceptability, safety, and clinical outcomes (postural control, gait, cognition, quality of life, mood, and fear of falling). DISCUSSION:Due to the deficiencies in multiple systems, studies have shown that multimodal interventions including motor-cognitive stimulation can improve the mobility of frail elderly adults. IVGs, among them the NWFP, are considered as a multimodal motor-cognitive intervention that can potentially improve motor and cognitive functions in the frail elderly. However, there is still no evidence in the literature that proves the feasibility, safety, acceptability, and functional outcomes of this intervention in frail elderly individuals. TRIAL REGISTRATION:Brazilian Registry of Clinical Trials (RBR-823rst). World Health Organization Trial Registration Data Set (Additional file 1).

Project description:BACKGROUND:The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed "Wii.n.Walk", an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA. OBJECTIVE:The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group. METHODS:This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants' homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks' duration. The primary outcome measure will be the "Two-Minute Walk Test" to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up. RESULTS:Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. CONCLUSIONS:Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. TRIAL REGISTRATION:Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP).

Project description:BackgroundStroke is a leading cause of disability. It is difficult to devise an optimal rehabilitation plan once stroke survivors are back home. Conventional rehabilitative therapies are extensively used in patients with stroke to recover motor functioning and disability, but these are arduous and expensive. Virtual reality (VR) video games inspire patients to get involved in their therapeutic exercise routine in a fun way. VR in the form of games provides a fruitful, secure, and challenging learning environment for motor control and neural plasticity development in rehabilitation. The effects of upper limb sensorimotor functioning and balance are the main focus of this trial.ObjectiveThe aim of this study is to compare the effects of VR training and routine physical therapy on balance and upper extremity sensorimotor function in patients with stroke.MethodsIt was a single assessor-blinded randomized clinical trial. A total of 74 participants with their first chronic stroke were included and rehabilitated in a clinical setting. The lottery method was used to randomly assign patients to either the VR group (n=37) or the routine physical therapy group (n=37). The VR group received a 1-hour session of VR training for 3 weekdays over 6 weeks, and the routine physical therapy group received different stretching and strengthening exercises. The outcome measuring tools were the Berg Balance Scale for balance and the Fugl-Meyer Assessment (upper extremity) scale for sensorimotor, joint pain, and range assessment. The assessment was done at the start of treatment and after the 6 weeks of intervention. Data analysis was done using SPSS 22.ResultsThe trial was completed by 68 patients. A significant difference between the two groups was found in the Berg Balance Scale score (P<.001), Fugl-Meyer Assessment for motor function (P=.03), and Fugl-Meyer Assessment for joint pain and joint range (P<.001); however, no significant difference (P=.19) in the Fugl-Meyer Assessment for upper extremity sensation was noted.ConclusionsVR training is helpful for improving balance and function of the upper extremities in the routine life of patients with stroke; although, it was not found to be better than conventional training in improving upper limb sensation. VR training can be a better option in a rehabilitation plan designed to increase functional capability.Trial registrationIranian Registry of Clinical Trials RCT20190715044216N1; https://www.irct.ir/user/trial/40898/view.

Project description:Background:Several studies have reported that using the Wii™ Balance Board can provide added value regarding balance (re-)training in neurological diseases. However, for the large group of mobile older stroke survivors, there is no evidence regarding the feasibility of an unsupervised Wii™ Balance Board training in the home setting. The aim of this study was to investigate the feasibility of a home-based Wii™ balance training for these patients and to identify methodological challenges for randomised controlled trials in the future. Methods:We conducted a pilot randomised controlled trial with two intervention arms in participants' homes. Mobile stroke survivors (aged 60 years or above; 12 weeks after discharge from hospital) received a 6-week (once per week) supervised balance training at the study centre, followed by a 6-week (three times per week) unsupervised balance training at home. We used the Nintendo Wii™ Balance Board for one intervention arm and conventional balance exercises for the other intervention arm. Feasibility was assessed by recruiting rates, appropriateness of assessments regarding sensitivity to changes and acceptance of the intervention by the participants. Results:In two German hospital stroke units, 349 stroke survivors were screened over a period of 6 months, 91 were eligible and 52 were interested. Twelve weeks after discharge, 14 participants agreed and 11 completed the intervention (7 men and 4 women, mean age 74 years). The Berg Balance Scale and Dynamic Gait Index showed ceiling effects already at baseline measure. The participants in both intervention arms evaluated the unsupervised training positively and feasible for self-application. No falls or injuries occurred over the intervention period, while the required scope of the exercises could largely be achieved. Conclusions:In this pilot study, the recruitment of participants and the chosen assessments were not satisfactory due to selection bias and corresponding ceiling effects. However, the two home-based balance interventions proved feasible for mobile older stroke survivors with low functional limitations. Trial registration:ClinicalTrials.gov, NCT02251470. Registered 29 September 2014.

Project description:ObjectiveTo assess the effect of exercise training by using the Nintendo Wii Fit video game and balance board system on balance and gait in adults with Parkinson disease (PD).DesignA prospective interventional cohort study.SettingAn outpatient group exercise class.ParticipantsTen subjects with PD, Hoehn and Yahr stages 2.5 or 3, with a mean age of 67.1 years; 4 men, 6 women.InterventionsThe subjects participated in supervised group exercise sessions 3 times per week for 8 weeks by practicing 3 different Wii balance board games (marble tracking, skiing, and bubble rafting) adjusted for their individualized function level. The subjects trained for 10 minutes per game, a total of 30 minutes training per session.Main outcome measurementsPre-and postexercise training, a physical therapist evaluated subjects' function by using the Berg Balance Scale, Dynamic Gait Index, and Sharpened Romberg with eyes open and closed. Postural sway was assessed at rest and with tracking tasks by using the Wii balance board. The subjects rated their confidence in balance by using the Activities-specific Balance Confidence scale and depression on the Geriatric Depression Scale.ResultsBalance as measured by the Berg Balance Scale improved significantly, with an increase of 3.3 points (P = .016). The Dynamic Gait Index improved as well (mean increase, 2.8; P = .004), as did postural sway measured with the balance board (decreased variance in stance with eyes open by 31%; P = .049). Although the Sharpened Romberg with eyes closed increased by 6.85 points and with eyes opened by 3.3 points, improvements neared significance only for eyes closed (P = .07 versus P = .188). There were no significant changes on patient ratings for the Activities-specific Balance Confidence (mean decrease, -1%; P = .922) or the Geriatric Depression Scale (mean increase, 2.2; P = .188).ConclusionsAn 8-week exercise training class by using the Wii Fit balance board improved selective measures of balance and gait in adults with PD. However, no significant changes were seen in mood or confidence regarding balance.

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Study protocol of a randomized clinical trial evaluating the effectiveness of a primary care intervention using the Nintendo™ Wii console to improve balance and decrease falls in the elderly.

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Study protocol of a randomized clinical trial evaluating the effectiveness of a primary care intervention using the Nintendo™ Wii console to improve balance and decrease falls in the elderly.

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