Re-Step: a Computerized Dynamic Balance Treatment for Rehabilitation of Unassisted Gait in ABI Victims: a Prospective, Exploratory and Interventional Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Community Balance & Mobility Scale (CB&M); Change from base line after intervention is being assessed
研究概览
简要总结
The purpose of this study is to:
- Test the walking functionality of people following Acquired brain injury (ABI)
- Suggesting a new treatment for their walking impairments
- Follow-up of motor learning ability and balance after intervention within this population
The investigators intend to target dynamic stability and gait after ABI, in a group of individuals with ABI who have persistent balance and mobility deficits despite being able to walk independently and having high scores on standard clinical balance measures.
Interventions: Training with Re-Step system shoes.
In this study there is no control group.
详细描述
Study design:
Type of research: Prospective, exploratory, clinical, interventional trial
Specific objectives are:
To explore the efficacy of Re-step rehabilitation technology to improve dynamic balance in the gait of people after Acquired Brain Injury (ABI).
The investigators suggest a new technology of intervention that will induce unexpected changes of underfoot slopes, with Re-Step shoes, during walking and will force the central nervous system (CNS) to react and solve walking problems in real-time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one year after the Acquired brain injury.
- •Age 18 to 80 years
- •Independent walking ability for at least 10 meters
- •Patients who permanently use medications that have not been changed during the past month and with no further changes expected during the research
- •At least 19 points on the MoCA test
排除标准
- •Presence of degenerative neurological disability that is not secondary to the acquired brain injury
- •Other disabilities such as - severe back pain, radical active lumbosacral radicular pain, leg muscle pain, peripheral neuropathy, post-polio syndrome, rheumatic illnesses, previous orthopedic disabilities preceding or at the time of the injury that could affect the ability and pattern of walking, depression, and other neurotic syndromes including post-traumatic depression and post-traumatic stress disorder (PTSD) at a medium level or higher, chronic alcoholism and use of drugs.
- •Unstable state of health such as heart disease, respiratory insufficiency, peripheral vascular disease, acquired brain injury that has impaired walking ability
- •Inability to persevere and cooperate in the series of tests and the follow-up
结局指标
主要结局
Community Balance & Mobility Scale (CB&M); Change from base line after intervention is being assessed
时间窗: Measuring mobility ability and balance at base line and changes after intervention; and changes and rtainment of achievments 6 months of no intervention
CB\&M was designed to evaluate balance and mobility in patients who, although ambulatory, have balance impairments that reduce their full engagement in community living. 13 items of dynamic balance are graded 0-5 by a physiotherapist. The CB\&M is a reliable and valid clinical outcome measure for evaluating change in ability in the higher functioning ambulatory patients with TBI.
次要结局
- 10 Meter walk Test (10MWT)(Measuring at base line; change immediately after intervention, and changes and retainments of achievments after 6 months)
- fMRI functional magnetic Resonance Imaging; Change from base line after intervention is being assessed(Base line brain activity; change after treatment; and change after 6 months with no interventions)
- Montreal Cognitive Assessment (MoCA)(Recruitment stage)