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临床试验/NCT03697915
NCT03697915Unknown不适用

Implementing Lift System to Physical Therapy Program for Early Mobilization in Immobilised Patients: A Randomised Controlled Trial

Istanbul Bilgi University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Mobility index

研究概览

简要总结

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.

详细描述

In this 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). 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.

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

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •undergone surgical procedures leading to immobilisation
  • •having a disease affecting the musculoskeletal system
  • •being conscious and not having sitting balance.

排除标准

  • •co-operation, orientation
  • •cognitive impairment.

研究组 & 干预措施

Experimental group

Experimental

Experimental group, in which a physical therapy programme supplemented by the James lift system was applied

干预措施: Experimental (Device)

Control

Placebo Comparator

Control group, in which a conventional physical therapy programme was applied.

干预措施: Experimental (Device)

结局指标

主要结局

Mobility index

时间窗: 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

次要结局

  • Daily life activities(3 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

TOMRIS DUYMAZ

Asst. Prof. Ph.D.

Istanbul Bilgi University

研究点 (1)

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