Validity of an Actigraph Accelerometer Following Critical Illness

Critical Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295630
• Other study ID #: R1978
• Status: Completed
• Phase: N/A
• Start date: September 19, 2016
• Est. completion date: April 21, 2017

Study information

• Verified date: October 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 21, 2017
• Est. primary completion date: April 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Posture
• Walking

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	Hull and East Yorkshire Hospitals NHS Trust	Hull	East Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of an Accelerometer to Identify Step Count	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	Comfort of Accelerometers	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: Very uncomfortable; Somewhat uncomfortable; Neither comfortable nor uncomfortable; Somewhat comfortable; 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

External Links

•   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.
•   Publication Link