Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001336279
Ethics application status
Approved
Date submitted
1/08/2018
Date registered
8/08/2018
Date last updated
3/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
lift system for early mobilization in immobilised patients
Scientific title
Implementing lift system to physical therapy program for early mobilization in immobilised patients: A randomised controlled trial
Secondary ID [1] 295709 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-immobilized patients 309104 0
orthopaedic surgery patients 309105 0
abdominal surgery patients 309106 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307981 307981 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each group had received 15 sessions of physical therapy (lower extremity hip flexion-extansion-abduction-adduction-internal rotation-external rotation, knee flexion-extansion and ankle flexion-extansion-inversion-eversion range of motion exercises and electrical stimulation on bilateral quadriceps muscles) regularly. The waveform of the electric stimulation is monophasic, the duration of the current is 150 ms, the frequency is 50 Hz, the modulation is rhythmic, and the amplitude is the contractional amplitude. The physical therapy sessions takes 45 minutes. A physiotherapist administered the intervention. 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.
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.
Intervention code [1] 302033 0
Treatment: Devices
Comparator / control treatment
active control.
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. 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 muscles) and ambulatory training.
Control group
Active

Outcomes
Primary outcome [1] 306956 0
Mobility as assessed by Rivermead Mobility Index (RMI) and Clinical Mobility Scale (CMS)
Timepoint [1] 306956 0
at the end of the treatment
Secondary outcome [1] 350225 0
hospitalization period collected by hospital records.
Timepoint [1] 350225 0
at the end of the treatment
Secondary outcome [2] 350424 0
the Barthel index
Timepoint [2] 350424 0
at the end of the treatment

Eligibility
Key inclusion criteria
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.
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria included co-operation, orientation and cognitive impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
two group
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS 22.0 statistical software was used for the analysis of the data in our study. After the descriptive statistical data were recorded, the Mann–Whitney U test was used for inter-group comparisons of non-parametric data and Wilcoxon test for intra-group comparisons before and after the therapy. The Spearman correlation analysis was performed to measure the degree of association between the variables. P <0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/10/2017
Date of last participant enrolment
Anticipated
Actual
1/01/2018
Date of last data collection
Anticipated
Actual
8/08/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 10721 0
Turkey
State/province [1] 10721 0
Istanbul

Funding & Sponsors
Funding source category [1] 300300 0
Self funded/Unfunded
Name [1] 300300 0
Tomris Duymaz
Country [1] 300300 0
Turkey
Primary sponsor type
Individual
Name
Tomris Duymaz
Address
Haci Ahmet Mh. Pir Husamettin Sk. No:20 34440 Beyoglu/Istanbul Turkey
Country
Turkey
Secondary sponsor category [1] 299787 0
None
Name [1] 299787 0
Address [1] 299787 0
Country [1] 299787 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301111 0
Istanbul Bilgi University
Ethics committee address [1] 301111 0
Ethics committee country [1] 301111 0
Turkey
Date submitted for ethics approval [1] 301111 0
04/09/2017
Approval date [1] 301111 0
09/10/2017
Ethics approval number [1] 301111 0
187

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2934 2934 0 0
/AnzctrAttachments/375711-tomris lift.manuscript.doc (Protocol)

Contacts
Principal investigator
Name 85902 0
Dr Tomris Duymaz
Address 85902 0
Istanbul Bilgi University. Haci Ahmet Mh. Pir Hüsamettin Sk. No:20 34440 Beyoglu/Istanbul
Country 85902 0
Turkey
Phone 85902 0
+905446302676
Fax 85902 0
Email 85902 0
[email protected]
Contact person for public queries
Name 85903 0
Tomris Duymaz
Address 85903 0
Istanbul Bilgi University. Haci Ahmet Mh. Pir Hüsamettin Sk. No:20 34440 Beyoglu/Istanbul.
Tomris Duymaz
Country 85903 0
Turkey
Phone 85903 0
+905446302676
Fax 85903 0
Email 85903 0
[email protected]
Contact person for scientific queries
Name 85904 0
Tomris Duymaz
Address 85904 0
Istanbul Bilgi University. Haci Ahmet Mh. Pir Hüsamettin Sk. No:20 34440 Beyoglu/Istanbul
Tomris Duymaz
Country 85904 0
Turkey
Phone 85904 0
+905446302676
Fax 85904 0
Email 85904 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.