Validity of an Actigraph Accelerometer Following Critical Illness

Criterion Validity of the Actigraph GT3X Accelerometer in Determination of Body Position and Walking in Hospital Ward Patients Recovering From Critical Illness

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom, HU3 2JZ
        • Hull and East Yorkshire Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability of an Accelerometer to Identify Step Count
Time Frame: Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol
Agreement between direct observation and the activity monitors (ankle and thigh placements in isolation) in determination of step count. The mean difference (95% Limits of Agreement) between observed step count and accelerometer quantified step count for the same walk were calculated. Negative values reflected an underestimation of observed step count by the accelerometer and positive values reflected an overestimation of step count.
Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort of Accelerometers
Time Frame: Accelerometers were worn for a period not exceeding 3 hours

Participants were asked to rate their assessment of how comfortable the accelerometers were. They were requested to choose a statement on a five-point Likert Scale. The statements were:

  1. Very uncomfortable
  2. Somewhat uncomfortable
  3. Neither comfortable nor uncomfortable
  4. Somewhat comfortable
  5. Very comfortable

Participants chose the most appropriate statement which they felt reflected how comfortable they found the accelerometers to wear.

Accelerometers were worn for a period not exceeding 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jayne Anderson, GradDipPhys, Hull University Teaching Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2016

Primary Completion (Actual)

April 21, 2017

Study Completion (Actual)

April 21, 2017

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 4, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • R1978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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