DisabilityMOBANCT05611723
Study and Analysis of Biomechanical Parameters of Human Movement Based on Disability Indicators in Older Adults
An observational study of Disability, run by Polytechnic Institute of Porto at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disability
- What is being tested?
- Exposure to disability
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2022to 2 Nov 2024
- Phase
- Observational
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Portuguese community-dwelling older adults
Who may be able to join
- older adults, 60 years or over;
- community-dwelling;
- able to perform the tasks (gait, sit-to-stand, climb and descend stairs) independently;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Center for Rehabilitation Research, School of Health, Polytechnic of Porto, Portugal
Porto, Porto District, 4200
About this study
Official title: Study and Analysis of Biomechanical Parameters of Human Movement Based on Disability Indicators in Older Adults Based on a Multifactorial Analysis: a Cross-sectional Study
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.
- Conditions
- Disability
- Being tested
- Exposure to disability
- Keywords
- Aged, Older Adults, Aging, Disability, Disability Evaluation, Biomechanical Phenomena, Biomechanical analysis, Kinematics, Kinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to disabilityOther
Disability status assessed by functional measures
| Study group | Role | What they receive |
|---|---|---|
| Healthy older Adults | Healthy older Adults: older adults without disability indicators | |
| Disability Older Adults | Disability Older Adults: older adults with disability indicators Receives: Other: Exposure to disability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waveforms from full-body joint angles
Waveforms from full-body joint angles measured in degrees (°)
Measured: During tasks performance
Waveform from full-body angular joint velocities
Waveform from angular joint velocities measured in degrees per second (°/s)
Measured: During tasks performance
Waveform from lower limb joint moments
Waveform from lower limb joint moments measured in Newton-meter (kgm²/s²)
Measured: During tasks performance
Waveform from total body energy
Waveform from total body energy measured in joules (J)
Measured: During tasks performance
Waveform from full-body separate segment energy
Waveform from body segment energy un joules (J)
Measured: During tasks performance
Waveform from lower body joint forces
Waveform from lower body joint forces measured in Newton (N)
Measured: During tasks performance
Waveform from lower body joint power
Waveform from lower body joint power measured in Watts
Measured: During tasks performance
Waveform from centre of mass displacement
Waveform from centre of mass displacement in m/s
Measured: During tasks performance
Waveform from centre of pressure displacement
Waveform from centre of pressure displacement in m/s
Measured: During tasks performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Jun 2022
- Primary completion30 Apr 2023
- Study completion2 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisabilityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polytechnic Institute of Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Rehabilitation Research - Polytechnic Institute of Porto (IPP), Universidade do Porto, School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
- Responsible party
- Principal investigator, Juliana dos Santos Moreira, Polytechnic Institute of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611723
- Sponsor's protocol ID
- CE0064C
- Other IDs
- 2020.05356.BD, UIDB/05210/2020
- Acronym
- MOBA
- Status last verified
- Nov 2024
- First submitted
- 6 Jul 2022
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study and Analysis of Biomechanical Parameters of Human Movement Based on Disability Indicators in Older Adults Based on a Multifactorial Analysis: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05611723
- Acronym / sponsor ID
- MOBA / CE0064C
- Conditions
- Disability
- Keywords
- Aged, Older Adults, Aging, Disability, Disability Evaluation, Biomechanical Phenomena, Biomechanical analysis, Kinematics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Polytechnic Institute of PortoUniversity, hospital or other
- Collaborators
- Center for Rehabilitation Research - Polytechnic Institute of Porto (IPP), Universidade do Porto, School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 2 Nov 2024 (actual)
- First posted
- 10 Nov 2022 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy older Adults | – | –Healthy older Adults: older adults without disability indicators |
| Disability Older Adults | – | Other: Exposure to disabilityDisability Older Adults: older adults with disability indicators |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Portuguese community-dwelling older adults
Key inclusion criteria (3 listed)
- older adults, 60 years or over;
- community-dwelling;
- able to perform the tasks (gait, sit-to-stand, climb and descend stairs) independently;
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| Exposure to disabilityDisability status assessed by functional measures | Other | Disability Older Adults |
Primary outcome
Waveforms from full-body joint angles
Time frame: During tasks performance
Waveforms from full-body joint angles measured in degrees (°)
Waveform from full-body angular joint velocities
Time frame: During tasks performance
Waveform from angular joint velocities measured in degrees per second (°/s)
Waveform from lower limb joint moments
Time frame: During tasks performance
Waveform from lower limb joint moments measured in Newton-meter (kgm²/s²)
Waveform from total body energy
Time frame: During tasks performance
Waveform from total body energy measured in joules (J)
Waveform from full-body separate segment energy
Time frame: During tasks performance
Waveform from body segment energy un joules (J)
Waveform from lower body joint forces
Time frame: During tasks performance
Waveform from lower body joint forces measured in Newton (N)
Waveform from lower body joint power
Time frame: During tasks performance
Waveform from lower body joint power measured in Watts
Waveform from centre of mass displacement
Time frame: During tasks performance
Waveform from centre of mass displacement in m/s
Waveform from centre of pressure displacement
Time frame: During tasks performance
Waveform from centre of pressure displacement in m/s
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 7 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disability, run by Polytechnic Institute of Porto at 1 site in Portugal.
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 3 inclusion and 10 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 7 Nov 2024. 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 Portugal. 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?
Waveforms from full-body joint angles (time frame: During tasks performance). The study lists 9 primary outcomes in all. 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 7 Nov 2024.