Implementing Lift System for Early Mobilization

NCT03697915 | Unknown DMC

• 1 other identifier: 2018-40016-46
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Inpatient Facililty Diagnoses

Keywords

Lift system; Early mobilization; Immobilization

Outcome Measures

Primary Outcomes (1)

• Mobility index

  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

  1 minute

Secondary Outcomes (1)

• Daily life activities

  3 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: Experimental

Control

PLACEBO COMPARATOR

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

Device: Experimental

Interventions

Experimental DEVICE

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.

Also known as: Control

Control; Experimental group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• co-operation, orientation
• cognitive impairment.

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Tomri̇s Duymaz

Istanbul, 34440, Turkey (Türkiye)

Location

Study Officials

• Tomri̇s Duymaz

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 5, 2018
• Study Start: June 2, 2018
• Primary Completion: September 25, 2018
• Study Completion: October 8, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

TU (1)