Critical CareNCT03295630
Validity of an Actigraph Accelerometer Following Critical Illness
A study testing Accelerometer in people with Critical Care and Walking, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Walking, Posture
- What is being tested?
- Accelerometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Sep 2016to 21 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull and East Yorkshire Hospitals NHS Trust
Hull, East Yorkshire, HU3 2JZ
About this study
Official title: 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.
Read the 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
- Being tested
- Accelerometer
- Keywords
- Accelerometry, Validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Actigraph GT3X accelerometer | Other | Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg Receives: Device: Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol
Secondary outcomes (1)
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.
Measured: Accelerometers were worn for a period not exceeding 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start19 Sep 2016
- Primary completion21 Apr 2017
- Study completion21 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ankle mounted Actigraph GT3X accelerometer
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jayne Anderson, GradDipPhys, Principal investigator, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295630
- Sponsor's protocol ID
- R1978
- Status last verified
- Oct 2019
- First submitted
- 25 Sep 2017
- Last updated
- 7 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Criterion Validity of the Actigraph GT3X Accelerometer in Determination of Body Position and Walking in Hospital Ward Patients Recovering From Critical Illness
- ClinicalTrials.gov ID
- NCT03295630
- Acronym / sponsor ID
- R1978
- Conditions
- Critical Care, Walking, Posture
- Keywords
- Accelerometry, Validity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Posted 7 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ankle mounted Actigraph GT3X accelerometer
| Arm | Type | Receives |
|---|---|---|
| Actigraph GT3X accelerometer | Other | Device: AccelerometerWard based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometerParticipants 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. | Device | Actigraph GT3X accelerometer |
Primary outcome
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.
1 secondary outcome
Comfort of Accelerometers
Time frame: Accelerometers were worn for a period not exceeding 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayne Anderson, GradDipPhys principal investigator
Hull University Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer in people with Critical Care and Walking, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.