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

NCT03479567 | Completed

• 1 other identifier: EC/2014/1240
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• walking speed

  gait speed parameter

  through study completion, an average of 3 years

• 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

• mediolateral jerk

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

  through study completion, an average of 3 years

• anteroposterior jerk

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

  through study completion, an average of 3 years

• 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

• 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

• MyotonPRO measurement of muscle tone

  MyotonPRO measurement

  through study completion, an average of 3 years

Secondary Outcomes (2)

• MyotonPRO measurement of elasticity

  through study completion, an average of 3 years

• MyotonPRO measurement of mechanical stiffness

  through study completion, an average of 3 years

Study Arms (3)

HC

OTHER

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

MiD

OTHER

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

MoD

OTHER

older adults with moderate dementia

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

Interventions

Gait accelerometry OTHER

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

HC; MiD; MoD

balance accelerometry OTHER

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

HC; MiD; MoD

Fine motor skill test OTHER

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

HC; MiD; MoD

Paratonia Assessment Instrument (PAI) DIAGNOSTIC_TEST

diagnosis of paratonia based on passive movement of the four limbs

HC; MiD

myotonometric measurement of muscle tone OTHER

MyotonPRO measurement of muscle tone

HC; MiD; MoD

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• recent (≤ 6 months) orthopedic surgery

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Vakgroep Revaki - Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Dementia; Muscle Rigidity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cross-sectional

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 27, 2018
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

BE (1)