Motor-cognitive Dual-task in Healthy Older Adults and Early Parkinson's Disease Patients

• Conditions: Parkinson Disease; Motor Disorders; Cognitive Impairment
• Interventions: Diagnostic Test: Extensive motor-cognitive testing protocol

• Registration Number: NCT05477654
• Lead Sponsor: Science and Research Centre Koper

Brief Summary

Neuromuscular dysfunction is common in older adults and even more pronounced in neurodegenerative diseases. In Parkinson's disease (PD), a complex set of factors often prevents effective performance of activities of daily living that require intact and simultaneous performance of motor and cognitive tasks. In the current study we aim at employing the Mobile Brain/Body Imaging approach (MoBI) to gain further insides of neuromuscular biomarkers revealing the decrements of older adults with an early PD. The cross-sectional study will be evaluated through the multifactorial mixed-measure design.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-26
• Last Update Submitted: 2022-07-27
• Study First Posted: 2022-07-28
• Study Start: 2022-08-01
• Last Update Posted: 2022-08-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria for the healthy older participants will be:

• no diagnosis of cognitive or movement disorder,
• score > 7 for the Short Physical Performance Battery (SPPB),
• living independently in the community,
• age range between 55 and 70 years,
• no color blindness.

Inclusion criteria for the early-stage PD patients:

• diagnosed according to the last MDS criteria (2015),
• duration of the disease less than 5 years,
• positive DATSCAN,
• diagnosed akinetic-rigid or mixed phenotype,
• score of 1 or maximally 2 on the Hoehn and Yahr scale (Hoehn & Yahr, 1967),
• MoCA score ≥ 24 points,
• score > 7 for the SPPB,
• age range between 50 and 75 years,
• no color blindness
• living independently in the community.

Exclusion Criteria

• advanced stages of PD (Hoehn and Yahr score > 2)
• any acute or chronic diseases, especially of the peripheral and central nervous system, heart failure, respiratory failure, severe osteoarthritis, and major psychiatric illness such as depression
• MoCA score < 24 points,
• severe disabling tremor,
• recurrent falls,
• impaired vision that is not corrected with e.g., glasses,
• low SPPB score

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Extensive motor-cognitive testing protocol	Healthy controls who are age-matched
Parkinson's disease patients	Extensive motor-cognitive testing protocol	Patients with an early diagnosis of Parkinson's disease

Primary Outcome Measures

Name	Time	Method
dual-task costs while standing	Day 1	Test for dual-task costs associated with the concurrent execution of semi-tandem stance and a secondary cognitive task
dual-task costs while execution of isometric task	Day 1	Test for dual-task costs associated with the concurrent execution of isometric contraction and a secondary cognitive task
dual-task costs while walking	Day 1	Test for dual-task costs associated with the concurrent execution of overground walking and a secondary cognitive task

Secondary Outcome Measures

Name	Time	Method
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Day 1	Assessment of various aspects of PD including motor and non-motor experience of daily living and the related complications

Trial Locations

Locations (1)

Science and research centre Koper; 🇸🇮 Koper, Slovenia