NCT05611723

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

July 6, 2022

Last Update Submit

November 5, 2024

Conditions

Keywords

AgedOlder AdultsAgingDisabilityDisability EvaluationBiomechanical PhenomenaBiomechanical analysisKinematicsKinetics

Outcome Measures

Primary Outcomes (9)

  • Waveforms from full-body joint angles

    Waveforms from full-body joint angles measured in degrees (°)

    During tasks performance

  • Waveform from full-body angular joint velocities

    Waveform from angular joint velocities measured in degrees per second (°/s)

    During tasks performance

  • Waveform from lower limb joint moments

    Waveform from lower limb joint moments measured in Newton-meter (kgm²/s²)

    During tasks performance

  • Waveform from total body energy

    Waveform from total body energy measured in joules (J)

    During tasks performance

  • Waveform from full-body separate segment energy

    Waveform from body segment energy un joules (J)

    During tasks performance

  • Waveform from lower body joint forces

    Waveform from lower body joint forces measured in Newton (N)

    During tasks performance

  • Waveform from lower body joint power

    Waveform from lower body joint power measured in Watts

    During tasks performance

  • Waveform from centre of mass displacement

    Waveform from centre of mass displacement in m/s

    During tasks performance

  • Waveform from centre of pressure displacement

    Waveform from centre of pressure displacement in m/s

    During tasks performance

Study Arms (2)

Healthy older Adults

Healthy older Adults: older adults without disability indicators

Disability Older Adults

Disability Older Adults: older adults with disability indicators

Other: Exposure to disability

Interventions

Disability status assessed by functional measures

Disability Older Adults

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Portuguese community-dwelling older adults

You may qualify if:

  • older adults, 60 years or over;
  • community-dwelling;
  • able to perform the tasks (gait, sit-to-stand, climb and descend stairs) independently;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Rehabilitation Research, School of Health, Polytechnic of Porto, Portugal

Porto, Porto District, 4200, Portugal

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of Science

Study Record Dates

First Submitted

July 6, 2022

First Posted

November 10, 2022

Study Start

June 1, 2022

Primary Completion

April 30, 2023

Study Completion

November 2, 2024

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations