- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05656690
Prospective Study and Analysis of Biomechanical Parameters of Human Movement Based on Disability Indicators in Older Adults (MOBA-P)
Study and Analysis of Biomechanical Parameters of Human Movement Based on Disability Indicators in Older Adults Based on a Multifactorial Analysis: a Prospective Cohort Study
Mobility loss in older people is caused by a variety of aging impairments in various body systems.The disability, which includes physical impairments and resulting activity limitations or participation restrictions, can arise acutely from a catastrophic illness or, more commonly, from subacute functional decline without a clear triggering event. Lower physical functioning was associated with higher healthcare utilization and expenditures, leading to a large burden on government-funded healthcare services. Early identification of mobility changes and intervening in them would likely be the most effective strategy to reduce the burden of disability in the population. Overall, there is a need to develop strategies to reduce disability among older adults in which kinetic and kinematic characteristics are used to predict disability status.
Accordingly, the purpose of this prospective cohort is to identify biomechanical parameters, from the gait, sit-to-stand, timed up and go, stair ascend and descend, and quiet standing functional tasks, as predictors of changes in health and disability status in older adults.
This research was funded by Fundação para a Ciência e Tecnologia (FCT), NORTE 2020, and European Social Fund of European Union, grant number 2020.05356.BD and through R&D Units funding (UIDB/05210/2020), Fundação para a Ciência e Tecnologia (FCT), Portugal and the European Union.
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Juliana S Moreira, Msc
- Phone Number: +351 222 061 000
- Email: jmo@ess.ipp.pt
Study Locations
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-
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Porto, Portugal, 4200
- Recruiting
- Center for Rehabilitation Research, School of Health, Polytechnic of Porto, Portugal
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Contact:
- Juliana S Moreira, Msc
- Phone Number: +351 222 061 000
- Email: jmo@ess.ipp.pt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- older adults, 60 years or over;
- community-dwelling;
- able to perform the tasks (gait, sit-to-stand, climb and descend stairs) independently;
Exclusion Criteria:
- older adults who are institutionalized;
- older adults who have established diagnosis of malignancy or terminal diseases with an anticipated survival of less than 1 year;
- older adults who have stroke history, cerebral hemorrhage, head trauma, or Parkinson's disease;
- older adults who have cognitive impairment, specifically Mini Mental StateExamination (Portuguese version) score of 22 for 0 to 2 years of literacy, 24 for 3 to6 years of literacy and 27 for more than 6 years of literacy (Morgado et al., 2009);
- older adults who have rheumatic pathologies that interfere with the tasks performance;
- older adults who have diabetic foot, lower limb fracture less than 6 weeks, or other related conditions;
- older adults who have unstable cardiovascular disease, liver or renal function failure;
- older adults who have a body mass index greater than or equal to 30 kg/m2;
- older adults who vestibular and/or audition or vision impairments non corrected that influence the performance of tasks;
- older adults who presence of symptoms at the time of evaluation that influences the participant performance of tasks.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy older Adults
Healthy older Adults: older adults without disability indicators
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Disability status assessed by functional measures
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Disability Older Adults
Disability Older Adults: older adults with disability indicators
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Disability status assessed by functional measures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waveforms from full-body joint angles
Time Frame: Assessed once at study entry.
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Waveforms from full-body joint angles measured in degrees (°)
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Assessed once at study entry.
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Waveform from full-body angular joint velocities
Time Frame: Assessed once at study entry
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Waveform from angular joint velocities measured in degrees per second (°/s)
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Assessed once at study entry
|
Waveform from lower limb joint moments
Time Frame: Assessed once at study entry
|
Waveform from lower limb joint moments measured in Newton-meter (kgm²/s²)
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Assessed once at study entry
|
Waveform from total body energy
Time Frame: Assessed once at study entry
|
Waveform from total body energy measured in joules (J)
|
Assessed once at study entry
|
Waveform from full-body separate segment energy
Time Frame: Assessed once at study entry
|
Waveform from body segment energy un joules (J)
|
Assessed once at study entry
|
Waveform from lower body joint forces
Time Frame: Assessed once at study entry
|
Waveform from lower body joint forces measured in Newton (N)
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Assessed once at study entry
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Waveform from lower body joint power
Time Frame: Assessed once at study entry
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Waveform from lower body joint power measured in Watts
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Assessed once at study entry
|
Waveform from centre of mass displacement
Time Frame: Assessed once at study entry
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Waveform from centre of mass displacement in m/s
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Assessed once at study entry
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Waveform from centre of pressure displacement
Time Frame: Assessed once at study entry
|
Waveform from centre of pressure displacement in m/s
|
Assessed once at study entry
|
International Physical Activity Questionnaire
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
|
IPAQ is questionnaire to assess self-reported physical activity
|
Assessed at study entry and evaluated every three months until the end of 1 year
|
Mini-Mental State Examination (MMSE)
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
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MMSE provides a brief screening test that quantitatively assesses the severity of cognitive impairment and documents cognitive changes occurring over time
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Assessed at study entry and evaluated every three months until the end of 1 year
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Barthel Index
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
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The Barthel Index is an instrument that assesses the individual's level of independence for ten activities of daily living
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Assessed at study entry and evaluated every three months until the end of 1 year
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Lawton and Brody Instrumental Activities of Daily Living Scale
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
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Lawton and Brody Instrumental Activities of Daily Living Scale assess the instrumental ADLs necessary for living in the community
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Assessed at study entry and evaluated every three months until the end of 1 year
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Number of health conditions
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
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Total number and description of health conditions
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Assessed at study entry and evaluated every three months until the end of 1 year
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Number of falls
Time Frame: Assessed at study entry and evaluated every three months until the end of 1 year
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Total number and description of ocurrences of falls
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Assessed at study entry and evaluated every three months until the end of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CE0077C
- 2020.05356.BD (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia, NORTE 2020, FSE EU)
- UIDB/05210/2020 (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia (FCT), Portugal and the European Union (EU))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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