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

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ClinicalTrials.gov Identifier: NCT03479567
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Vakgroeprevaki, University Ghent

Brief 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 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.

Condition or disease Intervention/treatment Phase
Dementia Gait Balance Muscle Tone Fine Motor Function Paratonia Other: Gait accelerometry Other: balance accelerometry Other: Fine motor skill test Diagnostic Test: Paratonia Assessment Instrument (PAI) Other: myotonometric measurement of muscle tone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cross-sectional
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479567


Locations
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Belgium
Vakgroep Revaki - Ghent University
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
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Responsible Party: Vakgroeprevaki, Principal investigator, University Ghent
ClinicalTrials.gov Identifier: NCT03479567    
Other Study ID Numbers: EC/2014/1240
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders