DementiaNCT03479567
Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia
A study testing Gait accelerometry, balance accelerometry and Fine motor skill test in people with Dementia and Gait, run by University Ghent at 1 site in Belgium.
Trial summary
The purpose of this study was (1) to investigate changes in gait, balance, fine motor function, and muscle tone, and (2) to find out if there is a correlation between muscle tone/presence of paratonia and motor function (gross and fine) in mild and moderate dementia.Three groups of participants were included in the… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Gait accelerometry, balance accelerometry and Fine motor skill test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age >= 65 years
- walk independently for at least 11 meters
- HC: no cognitive deterioration, MiD: dementia, Global Deterioration Scale<5, MoD: dementia, Global Deterioration Scale 5 or 6
Who cannot join
- recent (≤ 6 months) orthopedic surgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was (1) to investigate changes in gait, balance, fine motor function, and muscle tone, and (2) to find out if there is a correlation between muscle tone/presence of paratonia and motor function (gross and fine) in mild and moderate dementia.Three groups of participants were included in the study: healthy elderly (n=60), participants with mild dementia (n=31) and participants with moderate dementia (n=31). Measurements of fine motor function, balance, gait, presence of paratonia and muscle tone measurements were performed.
- Conditions
- Dementia, Gait, Balance, Muscle Tone, Fine Motor Function, Paratonia
- Being tested
- Gait accelerometry, balance accelerometry, Fine motor skill test, Paratonia Assessment Instrument (PAI), myotonometric measurement of muscle tone
- Medical subject headings
- Dementia, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait accelerometryOther
accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)
balance accelerometryOther
accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)
Fine motor skill testOther
assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual
Paratonia Assessment Instrument (PAI)Diagnostic test
diagnosis of paratonia based on passive movement of the four limbs
myotonometric measurement of muscle toneOther
MyotonPRO measurement of muscle tone
| Study group | Role | What they receive |
|---|---|---|
| HC | Other | Healthy controls, i.e. older adults without cognitive impairment Receives: Other: Gait accelerometry; Other: balance accelerometry; Other: Fine motor skill test; Diagnostic Test: Paratonia Assessment Instrument (PAI); Other: myotonometric measurement of muscle tone |
| MiD | Other | older adults with mild dementia Receives: Other: Gait accelerometry; Other: balance accelerometry; Other: Fine motor skill test; Diagnostic Test: Paratonia Assessment Instrument (PAI); Other: myotonometric measurement of muscle tone |
| MoD | Other | older adults with moderate dementia Receives: Other: Gait accelerometry; Other: balance accelerometry; Other: Fine motor skill test; Other: myotonometric measurement of muscle tone |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed
gait speed parameter
Measured: through study completion, an average of 3 years
step regularity
gait parameter representing regularity, autocorrelation (method Moe-Nilssen 2004), value between 0 and 1, with 1 representing perfect regularity
Measured: through study completion, an average of 3 years
mediolateral jerk
balance smoothness and coordination, lower jerk values correspond with better smoothness of balance
Measured: through study completion, an average of 3 years
anteroposterior jerk
balance smoothness and coordination, lower jerk values correspond with better smoothness of balance
Measured: through study completion, an average of 3 years
Fine motor function
score on the Purdue pegboard test, maximal amount of (pairs of) pegs placed in 30 seconds (max. 25)
Measured: through study completion, an average of 3 years
presence of paratonia
Paratonia Assessment Instrument, resistance against passive movements of the four limbs is evaluated (Hobbelen 2008)
Measured: through study completion, an average of 3 years
MyotonPRO measurement of muscle tone
MyotonPRO measurement
Measured: through study completion, an average of 3 years
Secondary outcomes (2)
MyotonPRO measurement of elasticity
MyotonPRO measurement
Measured: through study completion, an average of 3 years
MyotonPRO measurement of mechanical stiffness
MyotonPRO measurement
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study startJan 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cross-sectional
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479567
- Sponsor's protocol ID
- EC/2014/1240
- Status last verified
- Dec 2023
- First submitted
- 13 Mar 2018
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia
- ClinicalTrials.gov ID
- NCT03479567
- Acronym / sponsor ID
- EC/2014/1240
- Conditions
- Dementia, Gait, Balance, Muscle Tone, Fine Motor Function, Paratonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Mar 2018 (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.
The purpose of this study was (1) to investigate changes in gait, balance, fine motor function, and muscle tone, and (2) to find out if there is a correlation between muscle tone/presence of paratonia and motor function (gross and fine) in mild and moderate dementia.Three groups of participants were included in the study: healthy elderly (n=60), participants with mild dementia (n=31) and participants with moderate dementia (n=31). Measurements of fine motor function, balance, gait, presence of paratonia and muscle tone measurements were performed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- cross-sectional
| Arm | Type | Receives |
|---|---|---|
| HC | Other | Other: Gait accelerometry, Other: balance accelerometry, Other: Fine motor skill test, Diagnostic Test: Paratonia Assessment Instrument (PAI), Other: myotonometric measurement of muscle toneHealthy controls, i.e. older adults without cognitive impairment |
| MiD | Other | Other: Gait accelerometry, Other: balance accelerometry, Other: Fine motor skill test, Diagnostic Test: Paratonia Assessment Instrument (PAI), Other: myotonometric measurement of muscle toneolder adults with mild dementia |
| MoD | Other | Other: Gait accelerometry, Other: balance accelerometry, Other: Fine motor skill test, Other: myotonometric measurement of muscle toneolder adults with moderate dementia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age >= 65 years
- walk independently for at least 11 meters
- HC: no cognitive deterioration, MiD: dementia, Global Deterioration Scale<5, MoD: dementia, Global Deterioration Scale 5 or 6
Key exclusion criteria (1 listed)
- recent (≤ 6 months) orthopedic surgery
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 |
|---|---|---|
| Gait accelerometryaccelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task) | Other | HC, MiD, MoD |
| balance accelerometryaccelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem) | Other | HC, MiD, MoD |
| Fine motor skill testassessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual | Other | HC, MiD, MoD |
| Paratonia Assessment Instrument (PAI)diagnosis of paratonia based on passive movement of the four limbs | Diagnostic test | HC, MiD |
| myotonometric measurement of muscle toneMyotonPRO measurement of muscle tone | Other | HC, MiD, MoD |
Primary outcome
walking speed
Time frame: through study completion, an average of 3 years
gait speed parameter
step regularity
Time frame: through study completion, an average of 3 years
gait parameter representing regularity, autocorrelation (method Moe-Nilssen 2004), value between 0 and 1, with 1 representing perfect regularity
mediolateral jerk
Time frame: through study completion, an average of 3 years
balance smoothness and coordination, lower jerk values correspond with better smoothness of balance
anteroposterior jerk
Time frame: through study completion, an average of 3 years
balance smoothness and coordination, lower jerk values correspond with better smoothness of balance
Fine motor function
Time frame: through study completion, an average of 3 years
score on the Purdue pegboard test, maximal amount of (pairs of) pegs placed in 30 seconds (max. 25)
presence of paratonia
Time frame: through study completion, an average of 3 years
Paratonia Assessment Instrument, resistance against passive movements of the four limbs is evaluated (Hobbelen 2008)
MyotonPRO measurement of muscle tone
Time frame: through study completion, an average of 3 years
MyotonPRO measurement
2 secondary outcomes
MyotonPRO measurement of elasticity
Time frame: through study completion, an average of 3 years
MyotonPRO measurement of mechanical stiffness
Time frame: through study completion, an average of 3 years
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 18 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Gait accelerometry, balance accelerometry and Fine motor skill test in people with Dementia and Gait, run by University Ghent at 1 site in Belgium.
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 1 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 18 Dec 2023. 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 Belgium. 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?
walking speed (time frame: through study completion, an average of 3 years). The study lists 7 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 18 Dec 2023.