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Accidental Falls clinical trials

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NCT ID: NCT04398615 Not yet recruiting - Accidental Falls Clinical Trials

Validation of the ADAMO Watch for the Early Detection of Fall Events in Older Patients

ADAMO
Start date: May 25, 2020
Phase: N/A
Study type: Interventional

"La Casa nel Parco" (CANP) Project is a multidisciplinary project funded by the European Union and Regione Piemonte aimed to explore innovative technology application in the care of older subjects. In this context, ADAMO is a single arm open label trial evaluating the capability of a wearable watch device to correctly detect fall events in community-dwelling older subjects aged 75 years and older, at high risk of falls. Secondary objectives of the study are to identify specific patterns on telemetric measures and health status variations able to predict future fall events, and to evaluate the tolerability and the influence on patient's quality of life of this wearable device. The main objectives of the study are to evaluate the impact of the intervention on 1) medication adherence after discharge 2) medication appropriateness.

NCT ID: NCT04330053 Completed - Exercise Clinical Trials

Documentation of Fall Incidents and Application of a Fall Prevention Programme for Seniors in Northern Greece

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Due to the aging of the earth's population in the coming years, strategies for preventing falls in the elderly are of increasing research interest. Injuries due to falls have a direct impact on the quality of life of the elderly and are associated with very high costs for the healthcare system. However, few organized fall prevention interventions have been implemented in Greece, unlike other EU countries. The systematic recording of falls, the information and education of older people about injury prevention and the participation of older people in organized fall coping strategies in Greece are almost non-existent. Group exercise programs have proven to be effective in reducing falls. The OTAGO exercise program has shown that it can effectively reduce the number of falls in the elderly by up to 54%. However, its widespread implementation by a government agency in Greece such as the Elderly Day Care Centers (EDCC) has not yet been possible.

NCT ID: NCT04242186 Completed - Clinical trials for Accidental Falls/Prevention and Control

Nursing Home Prevention of Injury in Dementia (NH PRIDE)

NH PRIDE
Start date: October 30, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to develop a consistent approach to prevent falls with injury in nursing home (NH) residents. A centralized Injury Liaison Service (ILS) will be developed and tested in four nursing home facilities (two in the Durham, North Carolina area and two in the Boston, Massachusetts area). The ILS will combine successful elements of a Fracture Liaison Service (FLS) and video telehealth staff education (ECHO) models with the goal of decreasing injurious falls in nursing home residents. The ILS Program has four main components: 1. Automated identification of NH residents at high risk for falls with injury 2. Recommendations by the ILS nurse to manage medications, including deprescribing medications associated with falls and a prescription for osteoporosis medications 3. Video telehealth sessions to educate staff 4. Shared decision making with residents and/or families. The central hypothesis of this study is that the ILS model will reduce injurious falls by changing care delivery in two areas: deprescribing psychoactive and cardiometabolic drugs to reduce falls, and increasing osteoporosis treatment to prevent injury in the setting of a fall. Qualitative interviews will be conducted with nursing home staff to gain a better understanding of effective and non-effective injury prevention strategies. Information from these interviews will be incorporated into the study design. Outcome measures will focus on acceptability, demand, practicality, and feasibility of the program, as well as safety.

NCT ID: NCT04161625 Completed - Accidental Falls Clinical Trials

Evaluation of Reach, Effects and Cost Effectiveness of a Fall Preventive Intervention Including a mHealth Application

Start date: October 14, 2019
Phase: N/A
Study type: Interventional

The purpose is to evaluate reach, effects and costs effectiveness of a mobile, fall prevention exercise program for older community-dwelling persons (70+ years) in a pragmatic trial. Information about the study will be spread to the population by letters sent to all households with someone aged 70 years or older, presentations for senior organizations, advertisements on busses, health care centers, senior centers and in social media. Participants will be recruited in one municipality through the website (www.ostersund.se/sakrasteg) including information about the aim and procedures of the study. If seniors themselves judge that they are eligible to participate in the study, they can register by providing their email address. After baseline assessment, through self-reports in a digital survey, participants will get access to the mobile health application. The estimated target group is 2600 persons. Recruitment will be ongoing for six months. The intervention is delivered through the Safe Step application, developed in co-creation with seniors and researchers. Safe Step provides a large repository of evidence-based balance and strength exercises in video formats alongside falls preventive information and advice. With the Safe Step app the user can compose an individualized exercise program suitable for their needs. To help the user adhere to the program a set of behaviour change techniques is provided by the program. The user can set their own goals, get reminders and positive feedback form a virtual physiotherapist, and follow their own progress. Advice on how to integrate the exercises into everyday activities is also offered. The participants will exercise on their own with the help of the application for one year, with a recommendation of 30 minutes at least 3 times/week. In addition, participants will get monthly emails with falls preventive information in short videos, they will also be asked to report any falls by responding to a survey attached to the message. In order to maximize reach and to support participants to get started using the Safe Step application, technical support and group-based exercise will be provided. The interventions will last for 1 year with follow up assessments at 3, 6, 9, and 12 months in addition to the monthly fall reports. Effects and cost effectiveness will be evaluated in relation to a previously registered RCT NCT03963570.

NCT ID: NCT04053829 Recruiting - Aging Clinical Trials

Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls

HOLOBALANCE
Start date: September 2020
Phase: N/A
Study type: Interventional

This study will utilise an assessor blinded, randomised controlled design to investigate the acceptability and feasibility of providing a novel tele-rehabilitation balance training system (HOLOBalance) for community dwelling older adults at risk for falls. Older adults (age 65-80) who meet the inclusion criteria (e.g. independently living, no neurological conditions) will be recruited from falls services and from the wider community (via AgeUK) and will be randomly allocated to receive either a prescribed exercise programme delivered by: 1) the HOLOBalance tele-rehabilitation system or 2) an exercise booklet (The OTAGO Home Exercise Programme). Participants will be required to perform a series of prescribed exercises each day (duration of up to 30 minutes per day) for the entirety of the 8-week exercise programme. These exercises will be provided via the HOLOBalance tele-rehabilitation system (intervention arm) or by written instructions (control arm). Primary objectives for this study are to assess recruitment rate, compliance with exercise programmes (exercise diaries) and drop-out rates within the intervention group and a control group undertaking standard practice, home based balance rehabilitation (the OTAGO Home Exercise Programme) to explore whether HOLOBalance is acceptable to participants. Furthermore, acceptability to older adults will also be investigated via exit interviews performed within the HOLOBalance tele-rehabilitation intervention arm. Feasibility will be assessed by documenting adverse events (and SAE's), adverse device effects (and SADE's), deviations from protocol and feedback from treating clinicians. Implementation issues such as technology break down, service delivery and usability issues will also be documented. Secondary outcomes to explore trends for effectiveness will investigate performance of both groups at baseline and after the 8 week intervention across a range of outcome measures associated with balance function and falls risk, cognitive function, Physical activity and social participation, and subjective report of mobility and balance.

NCT ID: NCT04003779 Recruiting - Accidental Falls Clinical Trials

Reconfiguring the Patient Room to Increase Patient Stability

Start date: July 14, 2022
Phase: N/A
Study type: Interventional

Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.

NCT ID: NCT03963570 Completed - Accidental Falls Clinical Trials

The Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People

SafeStepRCT
Start date: September 27, 2019
Phase: N/A
Study type: Interventional

The overall aim of the study is to evaluate the effectiveness of a digital self-management exercise program in preventing falls in community dwelling older people. Participants will be recruited in Sweden through the website (www.sakrasteg.se) providing study information. On the website interested seniors will get information about the aim and procedures of the study as well as inclusion and exclusion criteria. If seniors themselves judge that they are eligible to participate in the study they can register by providing their email address. After baseline assessment, through self-reports in a digital survey, participants will be randomized to either an exercise intervention or a control group in a 1:1 ratio. The investigators aim to include 1400 participants and recruitment will be ongoing continuously for one year. The exercise intervention is delivered through the Safe Step application, developed in co-creation with seniors and an interdisciplinary research team. Safe Step provides a large repository of evidence based exercises in video formats alongside falls preventive information and advice. With support of this application the user can compose an individualized exercise program with balance and strength exercises suitable for their needs. To help the user adhere to the program a set of behaviour change techniques is provided by the program. The user can set their own goals, get reminders and positive feedback form a virtual physiotherapist, and follow their own progress. Advice on how to integrate the exercises into everyday activities is also offered. The participants will exercise on their own with the help of the application during one year, with a recommendation of 30 minutes at least 3 times/week. In addition to the exercise intervention the participants will every month get an email with falls preventive information in short videos, they will also be asked to report any falls by responding to a survey attached to the message. The exercise group will be compared to a control group that will receive the same information emails as the exercise group, but no individual exercise advice. The interventions will last for 1 year with follow up assessments at 3, 6, 9, and 12 month in addition the monthly fall reports. Due to the nature of the study, with no face to face contact, all outcome measures are self-reports and self-tests in digital surveys. The primary outcome is fall rate. The study follows the CONSORT guidelines and CONSORT EHEALTH criteria.

NCT ID: NCT03814304 Recruiting - Aging Clinical Trials

Personalized tDCS in Elderly Fallers Study

Start date: July 8, 2019
Phase: N/A
Study type: Interventional

The objective of this study is to determine if a four-week, 20-session intervention of personalized transcranial direct current stimulation (tDCS), as compared to sham intervention, improves dual task standing and walking performance (Aim 1), as well as other physical (Aim 2) and cognitive (Aim 3) factors on the causal pathway to falls, in older adults who report two or more falls within the past year and fear of falling again in the future, yet who do not have any acute or over neurological or musculoskeletal condition. Primary endpoints will include the "dual task" costs to gait speed when walking and postural sway speed when standing, as induced by performing a serial subtraction cognitive task (i.e., [(speeddual task - speedsingle task) / speedsingle task) X 100] (Aim 1), the Short Physical Performance Battery (Aim 2), and the Trail Making Test (Part B minus Part A) (AIM 3). Secondary endpoints will include the dual task cost to serial subtraction performance, additional gait and balance outcomes derived from the dual task paradigm, the Timed Up-and-Go, fear of falling, habitual physical activity, and performance within a battery of neuropsychological tests focused on global cognitive function, attention, verbal fluency and memory.

NCT ID: NCT03808831 Recruiting - Accidental Falls Clinical Trials

Fall Detection and Prevention System for the Elderly

Start date: January 20, 2019
Phase: N/A
Study type: Interventional

There is an urgent need for developing monitoring systems that can detect near-falls and alert persons who suffer from subsequently falls. Therefore, investigators propose a project to study the clinical application of a fall detection and prevention system for reducing falls in the elderly. The main objectives of the project are to develop the fall detection and prevention system and to investigate its effectiveness in preventing falls for the elderly. Eighty elderly will be recruited and randomly allocated into either the experimental or sham groups (n=40 for each group). Subjects in the experimental group will wear the fall detection and prevention system on the lower back. The system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events. In the sham group, subjects wear a sham system with record but no alert function. Both groups will receive the same treadmill walking training for 30 minutes per session, 3 sessions per week for 6 weeks. The outcome measures including falls, balance function, gait ability, physical activity, and quality of life will be assessed before intervention, after intervention, and at 6-months follow-up. Fall-induced physiological and psychological consequences limit daily activities and reduce quality of life in the elderly. The proposed study innovates a system that not only detects but also alarms users to prevent falls. Moreover, quantitative measurement of such fall detection and prevention system will be investigated for the elderly in this project. This study provides practical and efficacy solutions to prevent falls for home and community settings.

NCT ID: NCT03731572 Recruiting - Accidental Falls Clinical Trials

Hip Muscle Power, Lateral Balance Function, and Falls in Aging

HIPS
Start date: September 16, 2019
Phase: N/A
Study type: Interventional

Falls and their consequences are among the major problems in the medical care of older individuals. The long-term goal of this research is to develop a mechanistically based therapeutic intervention to enhance muscle power, weight-shifting capability, and lateral balance function through protective stepping to prevent falls. When human balance is challenged, protective stepping is a vital strategy for preventing a fall during activities of daily life. Many older people at risk for falls have particular difficulties with successfully stepping sideways as a protective response to loss of balance in the lateral direction. Age-related declines in lateral balance function result from neuromuscular and biomechanical limitations in hip abductor-adductor muscle power generation. This study will test whether these impairments can be improved with high-velocity hip muscle resistance power training that will be more effective than conventional resistance strength training.