Cerebrovascular AccidentNCT00849446
Validity and Reliability of an Activity Monitor in Persons With a Cerebrovascular Accident
An observational study of Cerebrovascular Accident, run by University College of Antwerp at 1 site in Belgium.
Trial summary
Background:Accelerometry has only recently been introduced in clinical stroke research. However, whether accelerometry is a valid and reliable tool in stroke needs to be established. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Activity monitor (SenseWear Pro armband)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2009to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.
Who may be able to join
- an ischemic or hemorrhagic stroke
- stroke onset less than 3 months
- score 3 or more Functional Ambulation Categories
- age < 80 years
- ability to cycle independently
- written authorisation on the informed consent
Who cannot join
- serious other diseases which might have an influence on carrying out the standardised activities
- cannot understand and carry out simple instructions
Trial locations and contacts
1 site in 1 country.
About this study
Background:Accelerometry has only recently been introduced in clinical stroke research. However, whether accelerometry is a valid and reliable tool in stroke needs to be established. From literature becomes clear that existing accelerometers show shortages at patients with stroke because of the specific deficits that these patients have.
Purpose: The aim of this study is to investigate the validity and test-retest reliability of the SenseWear Pro armband as an objective measurement of physical activity in chronic stroke patients.
Read more
Patients and Methods Subjects: Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.
Methods: During one test session the subjects had to carry out an amount of activities according to a standardised protocol existing of lying down, sitting, standing, walking, step exercise and cycling. These activities are presenting activities of daily living.
Measures:Subjects wear on both arms a SenseWear Pro Armband. De data from these measuring devices will be compared with the data retrieved from 2 Yamax pedometers and the ergospirometry device. The outcome measures are: counts, heartbeat, oxygen used, energy expenditure, METabolic equivalent, time lying down.
Read the detailed description
Evaluation of the SenseWear Pro Armband to assess physical activity in individuals with chronic stroke
Background:
Accelerometry has only recently been introduced in clinical stroke research. However, whether accelerometry is a valid and reliable tool in stroke needs to be established. From literature becomes clear that existing accelerometers show shortages at patients with stroke because of the specific deficits that these patients have.
Purpose:
The aim of this study is to investigate the validity and test-retest reliability of the SenseWear Pro armband as an objective measurement of physical activity in chronic stroke patients.
Patients and Methods Subjects Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.
Methods During one test session the subjects had to carry out an amount of activities according to a standardised protocol existing of lying down, sitting, standing, walking, step exercise and cycling. These activities are presenting activities of daily living.
Measures:
Subjects wear on both arms a SenseWear Pro Armband. De data from these measuring devices will be compared with the data retrieved from 2 Yamax pedometers and the ergospirometry device. The outcome measures are: counts, heartbeat, oxygen used, energy expenditure, METabolic equivalent, time lying down.
- Conditions
- Cerebrovascular Accident
- Being tested
- Activity monitor (SenseWear Pro armband)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity monitor (SenseWear Pro armband)Device
Also called Sensewear
Activity monitoring during specific physical activities such as walking at different speeds
| Study group | Role | What they receive |
|---|---|---|
| Activity monitoring in CVA patients | Not described Receives: Device: Activity monitor (SenseWear Pro armband) | |
| Activity monitoring in healthy persons | Not described Receives: Device: Activity monitor (SenseWear Pro armband) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy expenditure (kcal)during selected physical activities
Measured: measurement at 1 time point
Secondary outcomes (1)
Number of steps
Measured: measurement at 1 time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College of Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849446
- Sponsor's protocol ID
- ARTESIS-DepG-2009-1
- Status last verified
- Feb 2011
- First submitted
- 20 Feb 2009
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of an Activity Monitor in Persons With a Cerebrovascular Accident
- ClinicalTrials.gov ID
- NCT00849446
- Acronym / sponsor ID
- ARTESIS-DepG-2009-1
- Conditions
- Cerebrovascular Accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University College of AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- Feb 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:Accelerometry has only recently been introduced in clinical stroke research. However, whether accelerometry is a valid and reliable tool in stroke needs to be established. From literature becomes clear that existing accelerometers show shortages at patients with stroke because of the specific deficits that these patients have.
Purpose: The aim of this study is to investigate the validity and test-retest reliability of the SenseWear Pro armband as an objective measurement of physical activity in chronic stroke patients.
Patients and Methods Subjects: Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.
Methods: During one test session the subjects had to carry out an amount of activities according to a standardised protocol existing of lying down, sitting, standing, walking, step exercise and cycling. These activities are presenting activities of daily living.
Measures:Subjects wear on both arms a SenseWear Pro Armband. De data from these measuring devices will be compared with the data retrieved from 2 Yamax pedometers and the ergospirometry device. The outcome measures are: counts, heartbeat, oxygen used, energy expenditure, METabolic equivalent, time lying down.
Detailed description
Evaluation of the SenseWear Pro Armband to assess physical activity in individuals with chronic stroke
Background:
Accelerometry has only recently been introduced in clinical stroke research. However, whether accelerometry is a valid and reliable tool in stroke needs to be established. From literature becomes clear that existing accelerometers show shortages at patients with stroke because of the specific deficits that these patients have.
Purpose:
The aim of this study is to investigate the validity and test-retest reliability of the SenseWear Pro armband as an objective measurement of physical activity in chronic stroke patients.
Patients and Methods Subjects Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.
Methods During one test session the subjects had to carry out an amount of activities according to a standardised protocol existing of lying down, sitting, standing, walking, step exercise and cycling. These activities are presenting activities of daily living.
Measures:
Subjects wear on both arms a SenseWear Pro Armband. De data from these measuring devices will be compared with the data retrieved from 2 Yamax pedometers and the ergospirometry device. The outcome measures are: counts, heartbeat, oxygen used, energy expenditure, METabolic equivalent, time lying down.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity monitoring in CVA patients | – | Device: Activity monitor (SenseWear Pro armband) |
| Activity monitoring in healthy persons | – | Device: Activity monitor (SenseWear Pro armband) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.
Key inclusion criteria (6 listed)
- an ischemic or hemorrhagic stroke
- stroke onset less than 3 months
- score 3 or more Functional Ambulation Categories
- age < 80 years
- ability to cycle independently
Key exclusion criteria (2 listed)
- serious other diseases which might have an influence on carrying out the standardised activities
- cannot understand and carry out simple instructions
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 |
|---|---|---|
| Activity monitor (SenseWear Pro armband)Also: SensewearActivity monitoring during specific physical activities such as walking at different speeds | Device | Activity monitoring in CVA patients, Activity monitoring in healthy persons |
Primary outcome
Total energy expenditure (kcal)during selected physical activities
Time frame: measurement at 1 time point
1 secondary outcome
Number of steps
Time frame: measurement at 1 time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2011.
Related trials for Cerebrovascular Accident
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident, run by University College of Antwerp at 1 site in Belgium.
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 6 inclusion and 2 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 24 Aug 2011. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total energy expenditure (kcal)during selected physical activities (time frame: measurement at 1 time point). 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 24 Aug 2011.