Critical Care, Posture, Walking
Conditions
Keywords
Accelerometry, Validity
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.
Interventions
DEVICEAccelerometer
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.
Sponsors
Hull University Teaching Hospitals NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Ankle mounted Actigraph GT3X accelerometer
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability of an Accelerometer to Identify Step Count | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort of Accelerometers | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
20 hospital ward based participants recruited. Recruitment period September 2016 to April 2017
Participants by arm
| Arm | Count |
|---|---|
| Accelerometer Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg
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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Accelerometer | — |
|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 11.5 | — |
| Body mass index (BMI) | 25.9 kg/m^2 STANDARD_DEVIATION 6.1 | — |
| Gender Female | 7 Participants | — |
| Gender Male | 13 Participants | — |
| ICU overall length of stay | 21 days | — |
| Number of days receiving mechanical ventilation | 15 days | — |
| Overall hospital length of stay | 35 days | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 20 Years | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol
Population: Investigation of agreement between accelerometer quantified step count (ankle and thigh in isolation) and observed step count
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Accelerometer | Ability of an Accelerometer to Identify Step Count | 46 Observed steps |
Comparison: Difference (steps) between accelerometer quantified step count (thigh placement) and observed step count
Comparison: Correlation between accelerometer quantified step count (thigh placement) and observed step count95% CI: [-0.1, 0.78]
Comparison: Difference (steps) between accelerometer quantified steps (ankle placement) and observed step count
Comparison: Correlation between accelerometer quantified steps (ankle placement) and observed steps95% CI: [0.99, 1]
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: 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.
Time frame: Accelerometers were worn for a period not exceeding 3 hours
Population: Participants were asked to rate accelerometer comfort using a 5-point Likert Scale with the following statements:~'Very comfortable', 'Somewhat comfortable', 'Neither comfortable or uncomfortable', Somewhat uncomfortable', Very uncomfortable'
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Accelerometer | Comfort of Accelerometers | Very Comfortable | 16 Participants |
| Accelerometer | Comfort of Accelerometers | Somewhat comfortable | 3 Participants |
| Accelerometer | Comfort of Accelerometers | Neither comfortable or uncomfortable | 0 Participants |
| Accelerometer | Comfort of Accelerometers | Somewhat uncomfortable | 1 Participants |
| Accelerometer | Comfort of Accelerometers | Very uncomfortable | 0 Participants |