Clinical trial NCT03697915: Implementing Lift System for Early Mobilization
Official title: Implementing Lift System to Physical Therapy Program for Early Mobilization in Immobilised Patients: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inpatient Facililty Diagnoses
Keywords: Lift system
Early mobilization
Immobilization
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mobility index
timeFrame: 1 minute
Secondary outcomes:
measure: Daily life activities
timeFrame: 3 minutes
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Tomri̇s Duymaz
Study officials:
affiliation: Istanbul Bilgi University
name: Tomri̇s Duymaz
role: PRINCIPAL_INVESTIGATOR
References: