Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia

December 12, 2023 updated by: University Ghent
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Vakgroep Revaki - Ghent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • recent (≤ 6 months) orthopedic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: HC
Healthy controls, i.e. older adults without cognitive impairment
Other: Gait accelerometry
accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)
Other: balance accelerometry
accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)
Other: Fine motor skill test
assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual
Diagnostic test: Paratonia Assessment Instrument (PAI)
diagnosis of paratonia based on passive movement of the four limbs
Other: myotonometric measurement of muscle tone
MyotonPRO measurement of muscle tone
Other: MiD
older adults with mild dementia
Other: Gait accelerometry
accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)
Other: balance accelerometry
accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)
Other: Fine motor skill test
assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual
Diagnostic test: Paratonia Assessment Instrument (PAI)
diagnosis of paratonia based on passive movement of the four limbs
Other: myotonometric measurement of muscle tone
MyotonPRO measurement of muscle tone
Other: MoD
older adults with moderate dementia
Other: Gait accelerometry
accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)
Other: balance accelerometry
accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)
Other: Fine motor skill test
assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual
Other: myotonometric measurement of muscle tone
MyotonPRO measurement of muscle tone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
walking speed
Time Frame: through study completion, an average of 3 years
gait speed parameter
through study completion, an average of 3 years
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
through study completion, an average of 3 years
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
through study completion, an average of 3 years
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
through study completion, an average of 3 years
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)
through study completion, an average of 3 years
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)
through study completion, an average of 3 years
MyotonPRO measurement of muscle tone
Time Frame: through study completion, an average of 3 years
MyotonPRO measurement
through study completion, an average of 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MyotonPRO measurement of elasticity
Time Frame: through study completion, an average of 3 years
MyotonPRO measurement
through study completion, an average of 3 years
MyotonPRO measurement of mechanical stiffness
Time Frame: through study completion, an average of 3 years
MyotonPRO measurement
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC/2014/1240

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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