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Validity of an Actigraph Accelerometer Following Critical Illness

Primary Purpose

Critical Care, Walking, Posture

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Accelerometer
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Critical Care focused on measuring Accelerometry, Validity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hull and East Yorkshire Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Actigraph GT3X accelerometer

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 25, 2017
Last Updated
October 4, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03295630
Brief Title
Validity of an Actigraph Accelerometer Following Critical Illness
Official Title
Criterion Validity of the Actigraph GT3X Accelerometer in Determination of Body Position and Walking in Hospital Ward Patients Recovering From Critical Illness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
April 21, 2017 (Actual)
Study Completion Date
April 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Care, Walking, Posture
Keywords
Accelerometry, Validity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Ankle mounted Actigraph GT3X accelerometer
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Actigraph GT3X accelerometer
Arm Type
Other
Arm Description
Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg
Intervention Type
Device
Intervention Name(s)
Accelerometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ability of an Accelerometer to Identify Step Count
Description
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.
Time Frame
Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol
Secondary Outcome Measure Information:
Title
Comfort of Accelerometers
Description
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.
Time Frame
Accelerometers were worn for a period not exceeding 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Unable to provide informed written consent themselves Unwilling to consent to a period of observation not exceeding three hours. Unable to make an informed decision about participation or demonstrating an inability to interpret information or follow study instructions Significant neurological or coordination impairment Unable to speak or understand English. Clostridium Difficile/ similar infection or unmanaged urinary incontinence. Evidence/ diagnosis of peripheral vascular disease. Lower limb amputation Polytrauma which prevents the adoption or normal lying, sitting or standing postures, or placement of the accelerometers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayne Anderson, GradDipPhys
Organizational Affiliation
Hull University Teaching Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hull and East Yorkshire Hospitals NHS Trust
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Validity of an Actigraph Accelerometer Following Critical Illness

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