Validity of an Actigraph Accelerometer Following Critical Illness

NCT ID: NCT03295630

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-19
• Study Completion Date: 2017-04-21

Brief Summary

This study will determine whether an Actigraph GT3X accelerometer can identify body position and quantify step count in a ward based population recovering from critical illness.

Detailed Description

Ward based patients recovering from critical illness who satisfy the inclusion criteria will have an Actigraph GT3X accelerometer positioned on the thigh and ankle of the non dominant leg. These will be used as an objective method of identifying adoption of lying, sitting and standing postures and quantification of step count. Both placement sites will be investigated in isolation. A further analysis will be undertaken to determine whether combining data from both placement sites (ankle and thigh) is superior in identification of lying, sitting and standing postures compared to an isolated single site. Accelerometer data will be compared against direct observation as the criterion measure.

Patients will undertake a semi-structured movement protocol consisting of typical activities undertaken by this population. These include lying in bed, transferring over the side of the bed, sit to stand postural transfers (and the reverse), sitting in a chair and walking. Observation periods will not exceed 3 hours. During this time all aspects of the movement protocol will be completed.

The data from this study will be analysed to determine the validity of the Actigraph GT3X in identification of body position and quantification of step count using the placement sites described above.

Conditions

Critical Care; Walking; Posture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Actigraph GT3X accelerometer

Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg

Group Type: OTHER

Accelerometer

Intervention Type: DEVICE

Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count.

Interventions

Accelerometer

Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1 18 years of age or above.

2. Ventilated in excess of 48 hours during admission in the Intensive Care Unit (ICU).

3. Currently resident on a hospital ward (secondary care) following step down from ICU

4. Able to undertake all postural transfers independently or with minimal assistance (one person only).

5. Able to mobilise short distances, either independently or with assistance from a walking aid or one person.

6. Willing to permit application of two Actigraph GT3X accelerometers Each device weighs 27g with dimensions of 3.8cm x 3.7cm x 1.8cm.

7. Willing to consent to a period of direct observation for a length of time not exceeding three hours.

Exclusion Criteria

1. Unable to provide informed written consent themselves

2. Unwilling to consent to a period of observation not exceeding three hours.

3. Unable to make an informed decision about participation or demonstrating an inability to interpret information or follow study instructions

4. Significant neurological or coordination impairment

5. Unable to speak or understand English.

6. Clostridium Difficile/ similar infection or unmanaged urinary incontinence.

7. Evidence/ diagnosis of peripheral vascular disease.

8. Lower limb amputation

9. Polytrauma which prevents the adoption or normal lying, sitting or standing postures, or placement of the accelerometers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jayne Anderson, GradDipPhys

Role: PRINCIPAL_INVESTIGATOR

Hull University Teaching Hospitals NHS Trust

Locations

Hull and East Yorkshire Hospitals NHS Trust

Hull, East Yorkshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://journals.sagepub.com/doi/abs/10.1177/0269215519829893?journalCode=cea

Publication arising from the study found in the Journal Clinical Rehabilitation. Title: A study investigating the validity of an accelerometer in quantification of step count in adult hospital inpatients recovering from critical illness.

Other Identifiers

R1978

Identifier Type: -

Identifier Source: org_study_id