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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03479567
Other study ID # EC/2014/1240
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date December 2017

Study information

Verified date December 2023
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Gait accelerometry
accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)
balance accelerometry
accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)
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

Locations

Country Name City State
Belgium Vakgroep Revaki - Ghent University Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary walking speed gait speed parameter through study completion, an average of 3 years
Primary step regularity 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
Primary mediolateral jerk balance smoothness and coordination, lower jerk values correspond with better smoothness of balance through study completion, an average of 3 years
Primary anteroposterior jerk balance smoothness and coordination, lower jerk values correspond with better smoothness of balance through study completion, an average of 3 years
Primary Fine motor function 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
Primary presence of paratonia Paratonia Assessment Instrument, resistance against passive movements of the four limbs is evaluated (Hobbelen 2008) through study completion, an average of 3 years
Primary MyotonPRO measurement of muscle tone MyotonPRO measurement through study completion, an average of 3 years
Secondary MyotonPRO measurement of elasticity MyotonPRO measurement through study completion, an average of 3 years
Secondary MyotonPRO measurement of mechanical stiffness MyotonPRO measurement through study completion, an average of 3 years
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