Prospective Study and Analysis of Biomechanical Parameters of Human Movement Based on Disability Indicators in Older Adults

Disability Clinical Trial

— MOBA-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656690
• Other study ID #: CE0077C
• Secondary ID: 2020.05356.BDUID
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2022
• Source: Polytechnic Institute of Porto
• Contact: Juliana S Moreira, Msc
• Phone: +351 222 061 000
• Email: jmo[@]ess.ipp.pt
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disability

Intervention

Other:
• Exposure to disability
Disability status assessed by functional measures

Locations

Country	Name	City	State
Portugal	Center for Rehabilitation Research, School of Health, Polytechnic of Porto, Portugal	Porto

Sponsors (4)

Lead Sponsor	Collaborator
Polytechnic Institute of Porto	Center for Rehabilitation Research - Polytechnic Institute of Porto (IPP), Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto, School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waveforms from full-body joint angles	Waveforms from full-body joint angles measured in degrees (°)	Assessed once at study entry.
Primary	Waveform from full-body angular joint velocities	Waveform from angular joint velocities measured in degrees per second (°/s)	Assessed once at study entry
Primary	Waveform from lower limb joint moments	Waveform from lower limb joint moments measured in Newton-meter (kgm²/s²)	Assessed once at study entry
Primary	Waveform from total body energy	Waveform from total body energy measured in joules (J)	Assessed once at study entry
Primary	Waveform from full-body separate segment energy	Waveform from body segment energy un joules (J)	Assessed once at study entry
Primary	Waveform from lower body joint forces	Waveform from lower body joint forces measured in Newton (N)	Assessed once at study entry
Primary	Waveform from lower body joint power	Waveform from lower body joint power measured in Watts	Assessed once at study entry
Primary	Waveform from centre of mass displacement	Waveform from centre of mass displacement in m/s	Assessed once at study entry
Primary	Waveform from centre of pressure displacement	Waveform from centre of pressure displacement in m/s	Assessed once at study entry
Primary	International Physical Activity Questionnaire	IPAQ is questionnaire to assess self-reported physical activity	Assessed at study entry and evaluated every three months until the end of 1 year
Primary	Mini-Mental State Examination (MMSE)	MMSE provides a brief screening test that quantitatively assesses the severity of cognitive impairment and documents cognitive changes occurring over time	Assessed at study entry and evaluated every three months until the end of 1 year
Primary	Barthel Index	The Barthel Index is an instrument that assesses the individual's level of independence for ten activities of daily living	Assessed at study entry and evaluated every three months until the end of 1 year
Primary	Lawton and Brody Instrumental Activities of Daily Living Scale	Lawton and Brody Instrumental Activities of Daily Living Scale assess the instrumental ADLs necessary for living in the community	Assessed at study entry and evaluated every three months until the end of 1 year
Primary	Number of health conditions	Total number and description of health conditions	Assessed at study entry and evaluated every three months until the end of 1 year
Primary	Number of falls	Total number and description of ocurrences of falls	Assessed at study entry and evaluated every three months until the end of 1 year