Effects and Mechanisms of RAS Training on Upper-limb Movements in PD Patients

Not Applicable

Not yet recruiting

• Conditions: Electroencephalography; Parkinson Disease; Acoustic Stimulation
• Interventions: Behavioral: Upper-limb training involving RAS; Behavioral: Upper-limb training without the aid of RAS

• Registration Number: NCT05782322
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

Introduction Bradykinesia (i.e., slow movements) is one of the most prominent symptoms of Parkinson's disease (PD) and has a negative impact on quality of life. Rhythmic auditory stimulation (RAS), a widely used and promising treatment technique, has been shown to effectively improve gait speed in PD patients. However, only few studies have explored effects and neural mechanisms of RAS on upper-limb movements. We will conduct two studies to investigate effects and mechanisms of RAS on upper-limb movements in PD patients. The purpose of this study is to examine effects and neural mechanisms of upper-limb movement training involving RAS in PD patients.

Methods This study will recruit patients with PD and healthy controls. This study will randomly assign PD patients into two groups: the PD-RAS group and the PD-noRAS group, and healthy controls into the HC-RAS group and the HC-noRAS group. A 7-day upper-limb training involving RAS (for the PD-RAS group and the HC-RAS group) or without RAS (for the PD-noRAS group and the HC-noRAS group) will be provided. EEG and behavioral assessments will be conducted before and after the first day of training, and after the seven-day training program. Two-way repeated measures analysis of variance will be performed to investigate the group and time effects on upper-limb function and neural activity.

Study significance The training program will serve as a reference for clinical practitioners who are interested in using RAS in clinical training for PD patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Study Start: 2025-05-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• (a) idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria;
• (b) the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability;
• (c) a score of Montreal Cognitive Assessment (MoCA) is equal to or higher than 21 to ensure that they understand experimental instructions;
• (d) a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed;
• (e) types and doses of medications remain unchanged in the past month right before participation.
• Age- and sex-matched healthy controls who filled the criteria (c) and (d) will be recruited from communities.

Exclusion Criteria

• the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HC-RAS	Upper-limb training involving RAS	training involving RAS
PD-RAS	Upper-limb training involving RAS	training involving RAS
PD-noRAS	Upper-limb training without the aid of RAS	training without the aid of RAS
HC-noRAS	Upper-limb training without the aid of RAS	training without the aid of RAS

Primary Outcome Measures

Name	Time	Method
Electroencephalography (EEG)	Assessments will be performed after the seven-day training program.	The functional connectivity (unit:coherence) of EEG will be calculated.
The box and block test (BBT)	Assessments will be performed after the seven-day training program.	The BBT is used to measure gross manual dexterity as well as upper-limb movement speed.
The nine hole peg test (NHPT)	Assessments will be performed after the seven-day training program.	The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations.

Secondary Outcome Measures

Name	Time	Method
The Jebsen Hand Function Test (JHFT)	Assessments will be performed after the 7-day training.	The Jebsen Hand Function Test (JHFT) evaluated unimanual performance in activities of daily living through six standardized tasks: card turning, small object manipulation, simulated feeding, checker stacking, and moving both light and heavy objects. We modified the original seven-item test by excluding the writing task to accommodate Chinese-speaking participants, following established protocols for cross-cultural adaptation. Performance was measured by completion time for each task, with shorter times indicating better hand function. The JHFT demonstrates excellent test-retest reliability in PD patients (intraclass correlation coefficients: 0.89-0.97).
Ruler Drop Test (RDT)	Assessments will be performed after the 7-day training.	We assessed reaction time using the Ruler Drop Test (RDT). During this test, a ruler was positioned vertically between the participant's thumb and index finger, with its zero mark aligned at the fingertips. Following a ready signal from the participant, the examiner released the ruler without warning, requiring the participant to catch it as quickly as possible upon visual detection of movement. The falling distance was recorded, with greater distances indicating longer reaction times. The test was repeated three times, and the average distance was calculated. This measure reflects neuromotor processing speed, encompassing both visual information processing and movement initiation time.