DisabilityMOBA-PNCT05656690
Prospective 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
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… 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 May 2022to 31 Jul 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 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;
Show all 10Show fewer
- 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, 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 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.
- Conditions
- Disability
- Being tested
- Exposure to disability
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 Receives: Other: Exposure to disability | |
| 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: Assessed once at study entry.
Waveform from full-body angular joint velocities
Waveform from angular joint velocities measured in degrees per second (°/s)
Measured: Assessed once at study entry
Waveform from lower limb joint moments
Waveform from lower limb joint moments measured in Newton-meter (kgm²/s²)
Measured: Assessed once at study entry
Waveform from total body energy
Waveform from total body energy measured in joules (J)
Measured: Assessed once at study entry
Waveform from full-body separate segment energy
Waveform from body segment energy un joules (J)
Measured: Assessed once at study entry
Waveform from lower body joint forces
Waveform from lower body joint forces measured in Newton (N)
Measured: Assessed once at study entry
Waveform from lower body joint power
Waveform from lower body joint power measured in Watts
Measured: Assessed once at study entry
Waveform from centre of mass displacement
Waveform from centre of mass displacement in m/s
Measured: Assessed once at study entry
Waveform from centre of pressure displacement
Waveform from centre of pressure displacement in m/s
Measured: Assessed once at study entry
International Physical Activity Questionnaire
IPAQ is questionnaire to assess self-reported physical activity
Measured: Assessed at study entry and evaluated every three months until the end of 1 year
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
Measured: Assessed at study entry and evaluated every three months until the end of 1 year
Barthel Index
The Barthel Index is an instrument that assesses the individual's level of independence for ten activities of daily living
Measured: Assessed at study entry and evaluated every three months until the end of 1 year
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
Measured: Assessed at study entry and evaluated every three months until the end of 1 year
Number of health conditions
Total number and description of health conditions
Measured: Assessed at study entry and evaluated every three months until the end of 1 year
Number of falls
Total number and description of ocurrences of falls
Measured: Assessed at study entry and evaluated every three months until the end of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 May 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 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
- Cohort
- Time perspective
- Prospective
- 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
- NCT05656690
- Sponsor's protocol ID
- CE0077C
- Other IDs
- 2020.05356.BD, UIDB/05210/2020
- Acronym
- MOBA-P
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 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 Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05656690
- Acronym / sponsor ID
- MOBA-P / CE0077C
- Conditions
- Disability
- 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 May 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 19 Dec 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy older Adults | – | Other: Exposure to disabilityHealthy 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 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;
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, Healthy older Adults |
Primary outcome
Waveforms from full-body joint angles
Time frame: Assessed once at study entry.
Waveforms from full-body joint angles measured in degrees (°)
Waveform from full-body angular joint velocities
Time frame: Assessed once at study entry
Waveform from angular joint velocities measured in degrees per second (°/s)
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)
Waveform from total body energy
Time frame: Assessed once at study entry
Waveform from total body energy measured in joules (J)
Waveform from full-body separate segment energy
Time frame: Assessed once at study entry
Waveform from body segment energy un joules (J)
Waveform from lower body joint forces
Time frame: Assessed once at study entry
Waveform from lower body joint forces measured in Newton (N)
Waveform from lower body joint power
Time frame: Assessed once at study entry
Waveform from lower body joint power measured in Watts
Waveform from centre of mass displacement
Time frame: Assessed once at study entry
Waveform from centre of mass displacement in m/s
Waveform from centre of pressure displacement
Time frame: Assessed once at study entry
Waveform from centre of pressure displacement in m/s
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
Mini-Mental State Examination (MMSE)
Time frame: Assessed at study entry and evaluated every three months until the end of 1 year
MMSE provides a brief screening test that quantitatively assesses the severity of cognitive impairment and documents cognitive changes occurring over time
Barthel Index
Time frame: Assessed at study entry and evaluated every three months until the end of 1 year
The Barthel Index is an instrument that assesses the individual's level of independence for ten activities of daily living
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
Lawton and Brody Instrumental Activities of Daily Living Scale assess the instrumental ADLs necessary for living in the community
Number of health conditions
Time frame: Assessed at study entry and evaluated every three months until the end of 1 year
Total number and description of health conditions
Number of falls
Time frame: Assessed at study entry and evaluated every three months until the end of 1 year
Total number and description of ocurrences of falls
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.
Related trials for Disability
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effect of Kendall Versus McKenzie Exercises in Patients With Upper Crossed Syndrome
Upper Crossed Syndrome
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
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: Assessed once at study entry.). The study lists 15 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.