Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients

The Hong Kong Polytechnic University

Status: Not yet enrolling

Conditions: Bradykinesia; Parkinson Disease; Acoustic Stimulation; Arm; Movement, Abnormal

Treatments: Behavioral: Upper-limb movement training with the aid of RAS; Behavioral: Upper-limb movement training without the aid of RAS

Study type: Interventional

Funder types: Other

Identifiers

NCT05637593

HongKongPU21037721r_20221117

Details and patient eligibility

About

The goal of this clinical trial is to examine effects of training involving rhythmic auditory stimulation (RAS) on upper-limb movements and functions in patients with Parkinson's disease (PD).

This study employed a 21-day randomized controlled trial design to evaluate the efficacy of upper-limb training involving RAS on upper-limb function and neural activity in PD patients. The RAS group showed sustained improvements at one-month follow-up.

Full description

This study employed a randomized controlled trial design. We randomly assigned PD patients into either the RAS group (experimental) or the noRAS group (control). Both groups underwent a 21-day training program (40 minutes per session, one session daily), with the only difference being the presence or absence of RAS. Assessments were conducted at five time points: baseline (T1), day 8 (T2), day 15 (T3), post-intervention (T4), and one-month follow-up (T5). Behavioral assessments were performed at all time points, while EEG recordings were only conducted at baseline (T1) and post-intervention (T4). All assessments and training sessions were scheduled during participants' medication 'on' state (1-2 hours after medication intake) to ensure consistency and optimal motor function.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria;
• the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability;
• a score of Montreal Cognitive Assessment is equal to or higher than 21 to ensure that they understand experimental instructions;
• a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed;
• types and doses of medications remain unchanged in the past month right before participation.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

the RAS group

Experimental group

Description:

The RAS group will receive upper-limb movement training with the aid of RAS;

Treatment:

Behavioral: Upper-limb movement training with the aid of RAS

the no-RAS group

Active Comparator group

Description:

The no-RAS group will receive upper-limb movement training without the aid of RAS.

Treatment:

Behavioral: Upper-limb movement training without the aid of RAS