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

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • 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

      • 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

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
Intervention / Treatment
Other: HC
Healthy controls, i.e. older adults without cognitive impairment
accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)
accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)
assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual
diagnosis of paratonia based on passive movement of the four limbs
MyotonPRO measurement of muscle tone
Other: MiD
older adults with mild dementia
accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)
accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)
assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual
diagnosis of paratonia based on passive movement of the four limbs
MyotonPRO measurement of muscle tone
Other: MoD
older adults with moderate dementia
accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)
accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)
assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual
MyotonPRO measurement of muscle tone

What is the study measuring?

Primary Outcome Measures

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

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.

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)

January 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

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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