Clinical trial NCT05637593: Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients
Official title: Effects of Training Involving Rhythmic Auditory Stimulation on Upper-limb Movements in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acoustic Stimulation
Parkinson Disease
Movement, Abnormal
Bradykinesia
Arm
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The box and block test (BBT)
timeFrame: Baseline (T1). Before the training. BBT requires 8-10 minutes to administer.
measure: The box and block test (BBT)
timeFrame: Day 8 (T2). During the training. BBT requires 8-10 minutes to administer.
measure: The box and block test (BBT)
timeFrame: Day 15 (T3). During the training. BBT requires 8-10 minutes to administer.
measure: The box and block test (BBT)
timeFrame: Post-intervention (T4). BBT requires 8-10 minutes to administer.
measure: The box and block test (BBT)
timeFrame: One-month follow-up (T5). BBT requires 8-10 minutes to administer.
measure: The Jebsen hand function test (JHFT)
timeFrame: Baseline (T1). Before the training. JHFT takes approximately 15 minutes to administer.
measure: The Jebsen hand function test (JHFT)
timeFrame: Day 8 (T2). During the training. JHFT takes approximately 15 minutes to administer.
measure: The Jebsen hand function test (JHFT)
timeFrame: Day 15 (T3). During the training. JHFT takes approximately 15 minutes to administer.
measure: The Jebsen hand function test (JHFT)
timeFrame: Post-intervention (T4). JHFT takes approximately 15 minutes to administer.
measure: The Jebsen hand function test (JHFT)
timeFrame: One-month follow-up (T5). JHFT takes approximately 15 minutes to administer.
measure: Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III)
timeFrame: Baseline (T1). Before the training. MDS-UPDRS III takes approximately 15 minutes to administer.
measure: Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III)
timeFrame: Post-intervention (T4). MDS-UPDRS III takes approximately 15 minutes to administer.
measure: Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III)
timeFrame: One-month follow-up (T5). MDS-UPDRS III takes approximately 15 minutes to administer.
measure: The Nine-Hole Peg Test (NHPT)
timeFrame: Baseline (T1). Before the training. Before the training. NHPT takes approximately 5 minutes to administer.
measure: The Nine-Hole Peg Test (NHPT)
timeFrame: Day 8 (T2). During the training. NHPT takes approximately 5 minutes to administer.
measure: The Nine-Hole Peg Test (NHPT)
timeFrame: Day 15 (T3). During the training. NHPT takes approximately 5 minutes to administer.
measure: The Nine-Hole Peg Test (NHPT)
timeFrame: Post-intervention (T4). NHPT takes approximately 5 minutes to administer.
measure: The Nine-Hole Peg Test (NHPT)
timeFrame: One-month follow-up (T5). NHPT takes approximately 5 minutes to administer.
Secondary outcomes:
measure: Electroencephalography (EEG)
timeFrame: Baseline (T1). Before the training. It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal.
measure: Electroencephalography (EEG)
timeFrame: Post-intervention (T4). It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal.
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Wei FAN (PhD student), MSc
role: PRINCIPAL_INVESTIGATOR
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