Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients
- Conditions
- Parkinson DiseaseAcoustic StimulationBradykinesiaMovement, AbnormalArm
- Interventions
- Behavioral: Upper-limb movement training with the aid of RASBehavioral: Upper-limb movement training without the aid of RAS
- Registration Number
- NCT05637593
- Lead Sponsor
- The Hong Kong Polytechnic University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 138
- 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.
- 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 the RAS group Upper-limb movement training with the aid of RAS The RAS group will receive upper-limb movement training with the aid of RAS; the no-RAS group Upper-limb movement training without the aid of RAS The no-RAS group will receive upper-limb movement training without the aid of RAS.
- Primary Outcome Measures
Name Time Method The box and block test (BBT) One-month follow-up (T5). BBT requires 8-10 minutes to administer. BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7\* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.
The Jebsen hand function test (JHFT) One-month follow-up (T5). JHFT takes approximately 15 minutes to administer. JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale motor section (MDS-UPDRS III) One-month follow-up (T5). MDS-UPDRS III takes approximately 15 minutes to administer. The MDS-UPDRS evaluates various aspects of PD, including four parts: subjective non-motor experiences of daily living, subjective motor experiences of daily living, motor examination of the motor signs of PD, and motor complications based on historical and objective information. The scale is widely used in clinical settings as well as in research. We calculated the score of MDS-UPDRS Ⅲ, which is the motor examination of the motor signs, to assess the severity of bradykinesia.
The Nine-Hole Peg Test (NHPT) One-month follow-up (T5). NHPT takes approximately 5 minutes to administer. The NHPT is widely used measure of hand dexterity in a broad range of ages and population. The NHPT requires participants to quickly pick up nine small pegs from a concave receptacle, place them into holes on a board as fast as possible, and then move them back to the receptacle. The total time has been recorded as the result of NHPT, the less time taken indicate better hand dexterity. It has a high test-retest reliability for both hand (intraclass correlation coefficients of 0.88 to 0.91) and construct validity in PD population.
- Secondary Outcome Measures
Name Time Method Electroencephalography (EEG) Post-intervention (T4). It takes about 20 minutes to complete all the EEG recording procedures, including setup and removal. EEG recordings were conducted using a clinical-grade Nicolet Monitor system (Natus Medical Incorporated, USA). The system features comprehensive neurophysiological monitoring capabilities with high signal-to-noise ratio and stable recording characteristics. We employed a standard 19-electrode montage following the international 10-20 system, ensuring precise and reproducible electrode positioning based on anatomical landmarks.