Inpatient Facililty Diagnoses Clinical Trial
Official title:
Implementing Lift System to Physical Therapy Program for Early Mobilization in Immobilised Patients: A Randomised Controlled Trial
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.
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.
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.
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