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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05611723
Other study ID # CE0064C
Secondary ID 2020.05356.BDUID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date May 3, 2024

Study information

Verified date November 2023
Source Polytechnic Institute of Porto
Contact Juliana S Moreira, Msc
Phone +351 222 061 000
Email jmo@ess.ipp.pt
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Older adults develop modifications in the execution of movement that lead to impairments in activities of daily living performance. Accordingly, there is a need for technological advances in devices that assist older adults targeting improvements in parameters of movement performance that have the highest impact on the skills of daily living. Therefore, to gather the parameters of movement impacting daily living activities, the main goal of this study is to perform a comparative analysis of the biomechanical movement parameters between older adults with and without disability, performing the tasks: gait, sit-to-stand, timed up and go, quiet standing and climb and descend stairs. This work was supported by theFundação para a Ciência e Tecnologia (FCT), [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 May 3, 2024
Est. primary completion date March 1, 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 State Examination (Portuguese version) score of 22 for 0 to 2 years of literacy, 24 for 3 to 6 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 Design


Related Conditions & MeSH terms


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), School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP), Universidade do Porto

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 (°) During tasks performance
Primary Waveform from full-body angular joint velocities Waveform from angular joint velocities measured in degrees per second (°/s) During tasks performance
Primary Waveform from lower limb joint moments Waveform from lower limb joint moments measured in Newton-meter (kgm²/s²) During tasks performance
Primary Waveform from total body energy Waveform from total body energy measured in joules (J) During tasks performance
Primary Waveform from full-body separate segment energy Waveform from body segment energy un joules (J) During tasks performance
Primary Waveform from lower body joint forces Waveform from lower body joint forces measured in Newton (N) During tasks performance
Primary Waveform from lower body joint power Waveform from lower body joint power measured in Watts During tasks performance
Primary Waveform from centre of mass displacement Waveform from centre of mass displacement in m/s During tasks performance
Primary Waveform from centre of pressure displacement Waveform from centre of pressure displacement in m/s During tasks performance
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