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

NCT ID: NCT03479567

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia Gait Balance Muscle Tone Fine Motor Function Paratonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

cross-sectional
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HC

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

Group Type OTHER

Gait accelerometry

Intervention Type OTHER

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

balance accelerometry

Intervention Type OTHER

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

Fine motor skill test

Intervention Type OTHER

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

Paratonia Assessment Instrument (PAI)

Intervention Type DIAGNOSTIC_TEST

diagnosis of paratonia based on passive movement of the four limbs

myotonometric measurement of muscle tone

Intervention Type OTHER

MyotonPRO measurement of muscle tone

MiD

older adults with mild dementia

Group Type OTHER

Gait accelerometry

Intervention Type OTHER

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

balance accelerometry

Intervention Type OTHER

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

Fine motor skill test

Intervention Type OTHER

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

Paratonia Assessment Instrument (PAI)

Intervention Type DIAGNOSTIC_TEST

diagnosis of paratonia based on passive movement of the four limbs

myotonometric measurement of muscle tone

Intervention Type OTHER

MyotonPRO measurement of muscle tone

MoD

older adults with moderate dementia

Group Type OTHER

Gait accelerometry

Intervention Type OTHER

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

balance accelerometry

Intervention Type OTHER

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

Fine motor skill test

Intervention Type OTHER

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

myotonometric measurement of muscle tone

Intervention Type OTHER

MyotonPRO measurement of muscle tone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gait accelerometry

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

Intervention Type OTHER

balance accelerometry

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

Intervention Type OTHER

Fine motor skill test

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

Intervention Type OTHER

Paratonia Assessment Instrument (PAI)

diagnosis of paratonia based on passive movement of the four limbs

Intervention Type DIAGNOSTIC_TEST

myotonometric measurement of muscle tone

MyotonPRO measurement of muscle tone

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vakgroep Revaki - Ghent University

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EC/2014/1240

Identifier Type: -

Identifier Source: org_study_id