Improving Function and Mobility in Geriatric Patients After a Femoral Neck Fracture Who Are Undergoing Inpatient Rehabilitation Using an Augmented Reality Practice System - SELFIT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- PTPSQ-H physical therapy satisfaction questionnaire
研究概览
简要总结
Type of study: prospective interventional the purposes of the research :To examine the effect of treatment using the SELFIT system on function, walking and balance in patients after hip fractures hospitalized in the geriatric rehabilitation department.
The study population: 50 participants aged 65+ who were admitted to the geriatric rehabilitation department after hip fractures, with 25 in the experimental group and 25 in the control group.
The main question[s] it aims to answer are:
- What is the effect of training with SELFIT system on the functional outcomes in patients after hip fractures hospitalized in the geriatric rehabilitation department.
- How the training with SELFIT system will effect on satisfaction of the patients in the geriatric rehabilitation department.
During 21 days, both groups will receive physical therapy for about 45 minutes. The experimental group will be allocated about 15 minutes out of the 45 minutes to practice with the help of the SELFIT system.
详细描述
Recruiting participants for the study:
When admitting patients hospitalized in the geriatric rehabilitation department after hip neck fractures, their suitability for participation in the study will be examined according to inclusion and exclusion criteria. Patients who meet the inclusion criteria will receive an explanation of the research procedure and its goals, and if they agree and are suitable in terms of signature competence and cognitive ability to participate in the study, they will sign an informed consent form for participation in the study.
After signing a consent form to participate in the study, each participant will be randomly assigned to an experimental group or a control group. After the patient agrees to participate in the study, he will receive a number that will be assigned in sequential order, where an even number means belonging to the experimental group and an odd number, belonging to the control group.
Intervention:
During 21 days, both groups will receive physical therapy for about 45 minutes. The experimental group will be allocated about 15 minutes out of the 45 minutes to practice with the help of the SELFIT system.
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
- None
盲法说明
an assessment will be made by questionnaires and an objective assessment by physiotherapists who will not be involved in the treatment of the SELFIT system in the interventional group
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
- •Ability to walk independently or under supervision before the fracture
- •Patients with full weight bearing on the operated leg according to the instructions of an orthopedic surgeon (FWB - Full Weight Bearing)
- •Patients who are able to walk with an assistive device FIM 3 and above (FIM Functional independence measure)
- •Mental competence after a comprehensive assessment by a Geriatric Specialist
排除标准
- •Patients with cognitive decline following dementia or delirium
- •Patients with complications after surgery - infection or bleeding in the surgical area
- •Patients with previous neurological injury or current CNS disease.
- •Patients with a previous lower limb fracture in the last 5 years.
研究组 & 干预措施
SELFIT device group
25 patients in experimental group will receive 15 minutes with the SELFIT system during the 45 minutes of physical therapy
干预措施: Selfit Device group (Device)
Control Group
45 minutes of conventional physical therapy
干预措施: Control Group (Other)
结局指标
主要结局
PTPSQ-H physical therapy satisfaction questionnaire
时间窗: 9 month
Hebrew approved version. 15 questions about patient satisfaction with physical therapy care. Score range about 15 to 75. Higher score means better outcomes
Functional Independence Measure
时间窗: 9 month
Measured by: Functional Independence Measure Index (FIM) that assess activity of daily living. only motor assessment part is used. Minimum score 5 pts. Maximum score: 35 points. Higher score means better outcome
5 time sit to stand
时间窗: 9 month
Assessment of time performance for five time stand up and sitting on chair. Less time means better outcome
Berg Balance Test
时间窗: 9 month
Assessment of balance function by 14 tasks. Min.0 max.56 points Higher score means better outcome.
10 Meter walk test
时间窗: 9 month
Assessment of time performance of walking 10 meters. Less time means better outcome
Falls Efficacy Scale
时间窗: 9 month
Assessment of confidence of functions. Score range from 16 to 64 points. Higher score means better outcomes
VAS - visual analog scale
时间窗: 9 month
as mesured by a pain scale from 1 to 10. Lower score means better outcome
次要结局
未报告次要终点
研究者
Alexander Protsenko
Head of physiotherapy of geriatric rehabilitation unit
Meir Medical Center