- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03479567
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
Status
Completed
Conditions
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/2014/1240
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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