Comparison Between Treatment with Sensorized Treadmill and Conventional Therapy in Balance Disorders and Use of Artificial Intelligence in Identifying Predictive and Prognostic Indices of the Risk of Falling in Balance Disorders in Adult-elderly Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in Step Length of Gait Analysis
研究概览
简要总结
Falls in the elderly are one of the main sources of disability and hospitalization, with a significant impact on quality of life and social and healthcare costs. Falls represent a significant health concern for people over 60 years old. Numerous studies have shown that falls cause serious health consequences. Around 30% of people over the age of 60 experience a fall during the year.
According to the impact falls have, the investigators decided to analyze the effectiveness of training on a Walker View sensorized treadmill, with the possibility of exercises for coordination and balance, compared to training with a conventional group therapy, in order to understand the best training to reduce the risk of falling and observe the possible improvements in daily life activities.
So the study aims to identify the most effective rehabilitation method between a treatment with a sensorized treadmill (Walker View) and a conventional group therapy in balance disorders.
The study also aims to identify predictive indices, with the use of Artificial Intelligence, that can contribute to the prevention and diagnosis of balance disorders in a short time and prevent falls in the elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Consent to participate in the study
- •Positive history of balance disorders
- •Absence of cognitive deficits (MMSE ≥ 24)
- •Tinetti < 25
排除标准
- •Clinical pictures associated with musculoskeletal, cardiovascular, cerebrovascular, neuro-psychic problems and post-surgical outcomes that make the planned evaluation tests unfeasible.
- •Inability to carry out a walking test.
- •History of more than one fall in the last six months.
- •Subjects who have not expressed informed consent to participate in the study.
研究组 & 干预措施
Experimental Sensorized Treadmill
Patients will carry out treatment with a sensorized treadmill, Walker View. This treadmill gives the possibility to patients to see their image reconstructed in a 3D mode in order to observe the bad aligments that increase the patients balance disorders. The feedback systems are necessary to give continuous stimulation to the patients.
Each patients will carry out 18 treatment sessions and each session will last 30 minutes
干预措施: Treadmill (Other)
Conventional Therapy
Patients in this arm will carry out treatment with a conventional group therapy, consisting in usual treatment according to current clinical practice.
Each patient will undergo 18 sessions of conventional therapy based on group re-education.
干预措施: conventional therapy (Other)
Clinical monitoring
Patients in this arm will take part in the 'no intervention' part of the study and they will not carry out treatment. Patients will undergo only a clinical monitoring with an educational intervention, which does not elvove treatment or exercises, and they will continue to follow their daily habits.
结局指标
主要结局
Change in Step Length of Gait Analysis
时间窗: Baseline, 6 weeks, 10 weeks
The Gait Analysis is used to assess individuals with conditions that affect their ability to walk. It is a useful test for studying gait, thanks to instruments that measure the load on each limb and walking in general. It allows us to evaluate progresses at different time frames.
次要结局
- Balance(Baseline, 6 weeks, 10 weeks)
- Mobility(Baseline, 6 weeks, 10 weeks)
- Risk of falling(Baseline, 6 weeks, 10 weeks)
- Daily Living(Baseline, 6 weeks, 10 weeks)
- Instrumental Activites of Daily Living(Baseline, 6 weeks, 10 weeks)
- Muscle strength(Baseline, 6 weeks, 10 weeks)
- Patient reported Quality of Life(Baseline, 6 weeks, 10 weeks)
- Stability(Baseline, 6 weeks, 10 weeks)
研究者
Federica Bressi
Professor
Fondazione Policlinico Universitario Campus Bio-Medico