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

Primary Purpose

Dementia, Gait, Balance

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Gait accelerometry
balance accelerometry
Fine motor skill test
Paratonia Assessment Instrument (PAI)
myotonometric measurement of muscle tone
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vakgroep Revaki - Ghent University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

HC

MiD

MoD

Arm Description

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

older adults with mild dementia

older adults with moderate dementia

Outcomes

Primary Outcome Measures

walking speed
gait speed parameter
step regularity
gait parameter representing regularity, autocorrelation (method Moe-Nilssen 2004), value between 0 and 1, with 1 representing perfect regularity
mediolateral jerk
balance smoothness and coordination, lower jerk values correspond with better smoothness of balance
anteroposterior jerk
balance smoothness and coordination, lower jerk values correspond with better smoothness of balance
Fine motor function
score on the Purdue pegboard test, maximal amount of (pairs of) pegs placed in 30 seconds (max. 25)
presence of paratonia
Paratonia Assessment Instrument, resistance against passive movements of the four limbs is evaluated (Hobbelen 2008)
MyotonPRO measurement of muscle tone
MyotonPRO measurement

Secondary Outcome Measures

MyotonPRO measurement of elasticity
MyotonPRO measurement
MyotonPRO measurement of mechanical stiffness
MyotonPRO measurement

Full Information

First Posted
March 13, 2018
Last Updated
March 27, 2018
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03479567
Brief Title
Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia
Official Title
Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Gait, Balance, Muscle Tone, Fine Motor Function, Paratonia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cross-sectional
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HC
Arm Type
Other
Arm Description
Healthy controls, i.e. older adults without cognitive impairment
Arm Title
MiD
Arm Type
Other
Arm Description
older adults with mild dementia
Arm Title
MoD
Arm Type
Other
Arm Description
older adults with moderate dementia
Intervention Type
Other
Intervention Name(s)
Gait accelerometry
Intervention Description
accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)
Intervention Type
Other
Intervention Name(s)
balance accelerometry
Intervention Description
accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)
Intervention Type
Other
Intervention Name(s)
Fine motor skill test
Intervention Description
assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual
Intervention Type
Diagnostic Test
Intervention Name(s)
Paratonia Assessment Instrument (PAI)
Intervention Description
diagnosis of paratonia based on passive movement of the four limbs
Intervention Type
Other
Intervention Name(s)
myotonometric measurement of muscle tone
Intervention Description
MyotonPRO measurement of muscle tone
Primary Outcome Measure Information:
Title
walking speed
Description
gait speed parameter
Time Frame
through study completion, an average of 3 years
Title
step regularity
Description
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
Title
mediolateral jerk
Description
balance smoothness and coordination, lower jerk values correspond with better smoothness of balance
Time Frame
through study completion, an average of 3 years
Title
anteroposterior jerk
Description
balance smoothness and coordination, lower jerk values correspond with better smoothness of balance
Time Frame
through study completion, an average of 3 years
Title
Fine motor function
Description
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
Title
presence of paratonia
Description
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
Title
MyotonPRO measurement of muscle tone
Description
MyotonPRO measurement
Time Frame
through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
MyotonPRO measurement of elasticity
Description
MyotonPRO measurement
Time Frame
through study completion, an average of 3 years
Title
MyotonPRO measurement of mechanical stiffness
Description
MyotonPRO measurement
Time Frame
through study completion, an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Vakgroep Revaki - Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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