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CompletedNCT03479567Updated Dec 18, 2023

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

An interventional study of Gait accelerometry and balance accelerometry in Dementia, Gait and Balance, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by University Ghent · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Dementia
  • Gait
  • Balance
  • Muscle Tone
  • Fine Motor Function
  • Paratonia

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03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • recent (≤ 6 months) orthopedic surgery
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
122 participants (actual)

Study arms

  • Other
    HC

    Healthy controls, i.e. older adults without cognitive impairment

    Other: Gait accelerometry · Other: balance accelerometry · Other: Fine motor skill test · Diagnostic Test: Paratonia Assessment Instrument (PAI) · Other: myotonometric measurement of muscle tone

  • Other
    MiD

    older adults with mild dementia

    Other: Gait accelerometry · Other: balance accelerometry · Other: Fine motor skill test · Diagnostic Test: Paratonia Assessment Instrument (PAI) · Other: myotonometric measurement of muscle tone

  • Other
    MoD

    older adults with moderate dementia

    Other: Gait accelerometry · Other: balance accelerometry · Other: Fine motor skill test · Other: myotonometric measurement of muscle tone

Interventions

  • OtherGait accelerometry

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

  • Otherbalance accelerometry

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

  • OtherFine motor skill test

    assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual

  • Diagnostic testParatonia Assessment Instrument (PAI)

    diagnosis of paratonia based on passive movement of the four limbs

  • Othermyotonometric measurement of muscle tone

    MyotonPRO measurement of muscle tone

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What researchers measure

Primary outcomes

  1. walking speed

    gait speed parameter

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

  2. step regularity

    gait parameter representing regularity, autocorrelation (method Moe-Nilssen 2004), value between 0 and 1, with 1 representing perfect regularity

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

  3. mediolateral jerk

    balance smoothness and coordination, lower jerk values correspond with better smoothness of balance

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

  4. anteroposterior jerk

    balance smoothness and coordination, lower jerk values correspond with better smoothness of balance

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

  5. Fine motor function

    score on the Purdue pegboard test, maximal amount of (pairs of) pegs placed in 30 seconds (max. 25)

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

  6. presence of paratonia

    Paratonia Assessment Instrument, resistance against passive movements of the four limbs is evaluated (Hobbelen 2008)

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

  7. MyotonPRO measurement of muscle tone

    MyotonPRO measurement

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

Secondary outcomes

  1. MyotonPRO measurement of elasticity

    MyotonPRO measurement

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

  2. MyotonPRO measurement of mechanical stiffness

    MyotonPRO measurement

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

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Study locations

1 site
  • Vakgroep Revaki - Ghent University
    Ghent, 9000, Belgium
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03479567
Lead sponsor
University Ghent
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Jan 2015
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Dec 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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