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Completed

NCT Number: NCT03479567

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gait accelerometry

Other

accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)

balance accelerometry

Other

accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)

Fine motor skill test

Other

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 tone

Other

MyotonPRO measurement of muscle tone

Primary outcomes

  1. walking speed

    Time frame: through study completion, an average of 3 years

    gait speed parameter

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. MyotonPRO measurement of muscle tone

    Time frame: through study completion, an average of 3 years

    MyotonPRO measurement

Secondary outcomes

  1. MyotonPRO measurement of elasticity

    Time frame: through study completion, an average of 3 years

    MyotonPRO measurement

  2. MyotonPRO measurement of mechanical stiffness

    Time frame: through study completion, an average of 3 years

    MyotonPRO measurement

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 27, 2018
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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