Implementing Lift System for Early Mobilization
追踪信息 | |||
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首次提交日期 ICMJE | October 4, 2018 | ||
首次发布日期e ICMJE | October 5, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | June 2, 2018 | ||
预计主要完成日期 | September 25, 2018 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Mobility index[ Time Frame: 1 minute ] The Rivermead mobility index reflects basic mobility activities. The questionnaire consists of 15 questions, of which 14 are self-reported items and one is a direct observation item. "Yes" answers are given 1 point. The index is scored between 0 and 15 points, where 15 indicate normal mobility, whereas ≤14 indicate impaired mobility |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Implementing Lift System for Early Mobilization | ||
正式标题 ICMJE | Implementing Lift System to Physical Therapy Program for Early Mobilization in Immobilised Patients: A Randomised Controlled Trial | ||
简要概况 | Objective:Immobilization causes various physiological and biomechanical problems during inpatient treatments.Physical therapy is applied to achieve early mobilization and avoid complication of immobilization. Aim:The aim of this study is to assess the contribution of using lift system to physical therapy program of immobilized patients. Design:A randomised controlled trial. Patients:Thirty hospitalized patients who were immobile more than 1 week were randomised into two groups. Interventions: Each group had received 15 sessions of physical therapy (ROM exercises and electrotherapy) regularly.Patients allocated to the add-on lift system were held in upright position with James lift® system during each physical therapy(PT).Patients allocated to PT program only were upgraded to a therapeutic goal of stability during standing phase as the patient's muscular strength improved. |
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详细说明 | In our study, 30 patients aged 50-75 years who were immobilised for >1 week and were conscious but did not have sitting balance were evaluated. Before this study was initiated, approval was obtained from the XXX University Ethics Committee (number 2018-40016-46, dated 24/04/2018). Our study is a clinical trial. Our Clinical Trial Registry number is ACTRN12618001336279. The inclusion criteria for the study included having undergone surgical procedures leading to immobilisation or having a disease affecting the musculoskeletal system, being conscious and not having sitting balance. The exclusion criteria included co-operation, orientation and cognitive impairment. Patients were divided into two groups: control group, in which a conventional physical therapy programme was applied, and experimental group, in which a physical therapy programme supplemented by the James lift system was applied. Randomisation was performed according to the hospitalisation order of the patients. Conventional physical therapy was administered to the control group and was aimed at achieving sitting balance in the first phase; once sitting balance could be achieved, we aimed at achieving standing balance in the second phase. Once standing balance was also achieved, supported and unsupported ambulation was commenced in the final phase. In addition to the conventional treatment programme in the experimental group, orthostatic blood pressure was checked at the early stage before the patients gained sitting balance. Once the patients gained standing balance using the lift, they were administered walking training. Conventional physical therapy was administered to both the groups and included passive and active assisted joint range of motion exercises, sitting balance, standing balance, electrotherapy (20 min of electrical stimulation on bilateral quadriceps and muscles) and ambulatory training. Pre- and post-treatment evaluations included age, height, weight, duration of hospital stay and day of initial mobilisation. Clinical and Rivermead mobility indices were used as the primary outcome. The Barthel index, which assesses daily living activities, and hospitalisation period were evaluated as secondary outcomes. The James 150 lift system is a hydraulic system made of steel pipes with a carrying capacity of 150 kg and is designed to keep the patients in an upright position. It is a hydraulic transport system with a short installation time, including an electric lift arm, 24-Volt motor, wired remote control, emergency button, mechanical emergency lowering, extensible undercarriage pedal, swivel castors and rear-wheel brakes. When a patient is required to be switched to the upright position, he/she is supported by Velcro sheaths in the thoracolumbar area, knees are locked with knee supports, feet are switched to the dorsiflex position using the foot pedal and the patient is brought to the upright position. During this time, the patient grips the lift handles with his/her hands for support. The patient is protected against falling during the lifting process by the brake-lock system. The Rivermead mobility index reflects basic mobility activities. The questionnaire consists of 15 questions, of which 14 are self-reported items and one is a direct observation item. "Yes" answers are given 1 point. The index is scored between 0 and 15 points, where 15 indicate normal mobility, whereas ≤14 indicate impaired mobility. The clinical mobility scale evaluates the level of mobility and is scored between 0 and 3 points. It includes the following items: upright posture, walking, gait, sitting, stair climbing, hand-held appliances and wheelchair and time usage. It is scored between 0 and 24 points, and higher scores indicate increased mobility. The Barthel index scores daily life activities. The total score can range between 0 and 100 points, with each question score ranging from 0.5 to 10 points. The sub-topics covered include feeding, bathing, grooming, dressing, bowel care, bladder care, toilet use, transfer (bed to chair and back), mobility (on levelled surfaces) and stair climbing. Higher scores indicate improved independence of the patient. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Thirty hospitalized patients who were immobile more than 1 week were randomised into two groups. Each group had received 15 sessions of physical therapy (ROM exercises and electrotherapy) regularly. 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Active, not recruiting | ||
预计入组 ICMJE |
30 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | October 8, 2018 | ||
预计主要完成日期 | September 25, 2018 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - undergone surgical procedures leading to immobilisation - having a disease affecting the musculoskeletal system - being conscious and not having sitting balance. Exclusion Criteria: - co-operation, orientation - cognitive impairment. | ||
性别 |
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年龄 | 最小年龄:50 Years ,最大年龄:75 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Turkey | ||
管理信息 | 数据检测委员会 | Yes | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | TOMRIS DUYMAZ,Istanbul Bilgi University | ||
研究赞助商 ICMJE | Istanbul Bilgi University | ||
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研究员 ICMJE |
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PRS 账户 | Istanbul Bilgi University | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |