GeriatricsVAPODAGENCT03703011
Accelerometers' Validity in Counting Number of Steps in the Elderly Subjects Before Discharge From Rehabilitation Units
A study testing Accelerometers positioned at the wrinkle, the hip, and the ankle in people with Geriatrics, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Accelerometers enhance physical activity. Nevertheless, their validity (ability to accurately count steps) is not known in an elderly frail population ready for discharge from a rehabilitation unit. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Geriatrics
- What is being tested?
- Accelerometers positioned at the wrinkle, the hip, and the ankle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 29 Aug 2019
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age> 70 years
- Patients able to walk 10 meters,
- Maximum functional recovery obtained according to the physiotherapist judgment and ready for discharge,
- Patients able to understand the instructions and to freely consent (Mini mental state examination ≥ 20/30 and score at the consent scale: UBACC≥ 12/20)
- Written consent
- Unprotected adult
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- Covered by health insurance
- Non inclusion Criteria:
- Impossibility to walk the required distance (severe dyspnea, post fall syndrome, blindness, ..)
- Patients participating in another interventional research.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accelerometers' Validity in Counting Number of Steps in the Elderly Subjects Before Discharge From Rehabilitation Units, Having Reached Their Maximal Walking Ability After Physiotherapy. Comparison of the Accuracy of 3 Accelerometer Positions: Wrist, Ankle, Hip
Accelerometers enhance physical activity. Nevertheless, their validity (ability to accurately count steps) is not known in an elderly frail population ready for discharge from a rehabilitation unit. The objective was to assess accelerometers' validity for counting steps (10 meters), in comparison with the gold standard: steps counted by 2 physicians blind to accelerometers data, over a filmed 10-meter walk (minimal capacity to walk inside their own living place). The second objective was to evaluate the best position of the accelerometer: wrist, ankle, hip.
Read the detailed description
Accelerometers enhance physical activity. Only one study assessed accelerometers' validly in an elderly robust population, over 100m walking distance. The accelerometers' validly was demonstrated especially for the ankle position (Floegel et al., 2017). The primary objective was to assess accelerometers validity for counting steps in an elderly frail population ready for discharge from a rehabilitation unit. The comparison gold standard was steps count by 2 physicians blind to accelerometers data, over a filmed 10-meter walk (minimal capacity to walk inside their own living place). The second objective was to evaluate the best position of the accelerometer: wrist, ankle, hip.
Investigators included prospectively subjects aged ≥ 70 years, hospitalized in the Paul Brousse geriatric rehabilitation ward, able to walk at least 10 meters (maximum functional recovery according to the physiotherapist opinion) and with a Mini mental state examination ≥ 20/30 (able to understand). All subjects gave written informed consent and the study was approved by the local ethics committee. The secondary objective was to evaluate the position of the accelerometer that give the most accurate step count: wrist, ankle, hip. The study took place in the Paul Brousse hospital in Villejuif in rehabilitations units. Falls during the protocol were considered as the only risk. To prevent this risk a physiotherapist walked behind the participants during the 10-meter walk. Demographic, clinical, physiological data were recorded and anonymized. In this monocentric non-randomized study, the number of participants to include was 120. Twenty participants were planned to be included each month during 6 months. Statistical analysis will be made by a T test to measure the difference between the gold standard and the count of the accelerometers. To eliminate measurement bias, Bland Altman analysis will be performed. Interclass correlation will be performed to measure the differences between accelerometers' positions. Logistic regressions will be done with measurement's variability determinants. In all analyses, the 2-sided α-level of 0.05 was used for significance testing.. All analysis will be performed using R statistical software.
- Conditions
- Geriatrics
- Being tested
- Accelerometers positioned at the wrinkle, the hip, and the ankle
- Keywords
- geriatrics, discharge, Accelerometers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerometers positioned at the wrinkle, the hip, and the ankleDevice
Accelerometers are positioned at the wrinkle, the hip, and the ankle. The subject stands and walks 10 meters, followed up by a physiotherapist in the physiotherapy area. The accelerometers are triggered by a smartphone. The protocol is filmed (without the face), and 2 physicians will watch the film and count the steps blind to the results of the accelerometers (and blind to each-other steps counts)
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Subjects aged >70 years, hospitalized in the rehabilitation geriatric ward in the Paul Brousse hospital, France, able to walk 10 meters, ready to be discharged, and a Mini mental state examination ≥ 20/30 Receives: Device: Accelerometers positioned at the wrinkle, the hip, and the ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matching between number of steps measured by the accelerometers and the number of steps counted by the physicians visioning the film.
A step is counted when a foot touches the ground
Measured: 3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.)
Secondary outcomes (3)
Matching between number of steps measured by the accelerometers worn on the ankle and the number of steps counted by the physicians visioning the film.
a step is counted when a foot touches the ground. Comparison between number of steps measured by the accelerometers worn on the ankle and the number of steps counted by the physicians visioning the film.
Measured: 3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.)
Matching between number of steps measured by the accelerometers worn on the wrist and the number of steps counted by the physicians visioning the film.
a step is counted when a foot touches the ground. Comparison between number of steps measured by the accelerometers worn on the wrist and the number of steps counted by the physicians visioning the film.
Measured: 3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.)
Best matching between the number of steps evaluated by the accelerometers and the the number of steps counted by the physicians visioning the film according to the accelerometers positions (hip, ankle, wrist).
a step is counted when a foot touches the ground. Comparison of the best matching between the number of steps evaluates by accelerometers worn on the hip, the ankle and the wrist and the number of steps counted by the physicians visioning the film.
Measured: 3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Mar 2019
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle DURON, Md, PhD, Principal investigator, APHP,Paul Brousse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703011
- Sponsor's protocol ID
- 17004
- Other IDs
- 2018-A00348-47
- Acronym
- VAPODAGE
- Status last verified
- Apr 2019
- First submitted
- 9 Oct 2018
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerometers' Validity in Counting Number of Steps in the Elderly Subjects Before Discharge From Rehabilitation Units, Having Reached Their Maximal Walking Ability After Physiotherapy. Comparison of the Accuracy of 3 Accelerometer Positions: Wrist, Ankle, Hip
- ClinicalTrials.gov ID
- NCT03703011
- Acronym / sponsor ID
- VAPODAGE / 17004
- Conditions
- Geriatrics
- Keywords
- geriatrics, discharge, Accelerometers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 11 Oct 2018 (actual)
- 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.
Accelerometers enhance physical activity. Nevertheless, their validity (ability to accurately count steps) is not known in an elderly frail population ready for discharge from a rehabilitation unit. The objective was to assess accelerometers' validity for counting steps (10 meters), in comparison with the gold standard: steps counted by 2 physicians blind to accelerometers data, over a filmed 10-meter walk (minimal capacity to walk inside their own living place). The second objective was to evaluate the best position of the accelerometer: wrist, ankle, hip.
Detailed description
Accelerometers enhance physical activity. Only one study assessed accelerometers' validly in an elderly robust population, over 100m walking distance. The accelerometers' validly was demonstrated especially for the ankle position (Floegel et al., 2017). The primary objective was to assess accelerometers validity for counting steps in an elderly frail population ready for discharge from a rehabilitation unit. The comparison gold standard was steps count by 2 physicians blind to accelerometers data, over a filmed 10-meter walk (minimal capacity to walk inside their own living place). The second objective was to evaluate the best position of the accelerometer: wrist, ankle, hip.
Investigators included prospectively subjects aged ≥ 70 years, hospitalized in the Paul Brousse geriatric rehabilitation ward, able to walk at least 10 meters (maximum functional recovery according to the physiotherapist opinion) and with a Mini mental state examination ≥ 20/30 (able to understand). All subjects gave written informed consent and the study was approved by the local ethics committee. The secondary objective was to evaluate the position of the accelerometer that give the most accurate step count: wrist, ankle, hip. The study took place in the Paul Brousse hospital in Villejuif in rehabilitations units. Falls during the protocol were considered as the only risk. To prevent this risk a physiotherapist walked behind the participants during the 10-meter walk. Demographic, clinical, physiological data were recorded and anonymized. In this monocentric non-randomized study, the number of participants to include was 120. Twenty participants were planned to be included each month during 6 months. Statistical analysis will be made by a T test to measure the difference between the gold standard and the count of the accelerometers. To eliminate measurement bias, Bland Altman analysis will be performed. Interclass correlation will be performed to measure the differences between accelerometers' positions. Logistic regressions will be done with measurement's variability determinants. In all analyses, the 2-sided α-level of 0.05 was used for significance testing.. All analysis will be performed using R statistical software.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Accelerometers positioned at the wrinkle, the hip, and the ankleSubjects aged >70 years, hospitalized in the rehabilitation geriatric ward in the Paul Brousse hospital, France, able to walk 10 meters, ready to be discharged, and a Mini mental state examination ≥ 20/30 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Age> 70 years
- Patients able to walk 10 meters,
- Maximum functional recovery obtained according to the physiotherapist judgment and ready for discharge,
- Patients able to understand the instructions and to freely consent (Mini mental state examination ≥ 20/30 and score at the consent scale: UBACC≥ 12/20)
- Written consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Accelerometers positioned at the wrinkle, the hip, and the ankleAccelerometers are positioned at the wrinkle, the hip, and the ankle. The subject stands and walks 10 meters, followed up by a physiotherapist in the physiotherapy area. The accelerometers are triggered by a smartphone. The protocol is filmed (without the face), and 2 physicians will watch the film and count the steps blind to the results of the accelerometers (and blind to each-other steps counts) | Device | Interventional |
Primary outcome
Matching between number of steps measured by the accelerometers and the number of steps counted by the physicians visioning the film.
Time frame: 3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.)
A step is counted when a foot touches the ground
3 secondary outcomes
Matching between number of steps measured by the accelerometers worn on the ankle and the number of steps counted by the physicians visioning the film.
Time frame: 3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.)
Matching between number of steps measured by the accelerometers worn on the wrist and the number of steps counted by the physicians visioning the film.
Time frame: 3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.)
Best matching between the number of steps evaluated by the accelerometers and the the number of steps counted by the physicians visioning the film according to the accelerometers positions (hip, ankle, wrist).
Time frame: 3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.)
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 19 Nov 2019.
- 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.
Emmanuelle DURON, Md, PhD principal investigator
APHP,Paul Brousse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometers positioned at the wrinkle, the hip, and the ankle in people with Geriatrics, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 0 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 19 Nov 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 France. 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?
Matching between number of steps measured by the accelerometers and the number of steps counted by the physicians visioning the film. (time frame: 3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.)). 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 19 Nov 2019.