Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05637593

Collaborator

(none)

138

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Patients will be randomly divided into two groups: the RAS group and the no-RAS group. Patients will receive training with or without the aid of RAS based on their groups. The training task is to use the right hand to take beads from one bowl to another bowl. The box and block test and the Jebsen hand function test will be used before and after training (i.e., pretest and posttest respectively) to assess patients' upper-limb speed and function. Researchers will compare scores of the box and block test and the Jebsen hand function test between the two groups at pretest and posttest to determine effects of RAS.

Condition or Disease	Intervention/Treatment	Phase
Acoustic Stimulation Parkinson Disease Movement, Abnormal Bradykinesia Arm	Behavioral: Upper-limb movement training with the aid of RAS Behavioral: Upper-limb movement training without the aid of RAS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Training Involving Rhythmic Auditory Stimulation on Upper-limb Movements in Patients With Parkinson's Disease

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the RAS group The RAS group will receive upper-limb movement training with the aid of RAS;	Behavioral: Upper-limb movement training with the aid of RAS Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient. Patients will be asked to listen to the RAS sound, use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They should keep their movements consistent with the sound of the RAS, with one RAS sound corresponding to one pick-up movement. Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 21 days.
Active Comparator: the no-RAS group The no-RAS group will receive upper-limb movement training without the aid of RAS.	Behavioral: Upper-limb movement training without the aid of RAS Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient. Patients will be asked to use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They are asked to execute the task as fast as possible. Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 21 days.

Arm

Intervention/Treatment

Experimental: the RAS group

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

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

Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient. Patients will be asked to listen to the RAS sound, use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They should keep their movements consistent with the sound of the RAS, with one RAS sound corresponding to one pick-up movement. Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 21 days.

Active Comparator: the no-RAS group

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

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

Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient. Patients will be asked to use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They are asked to execute the task as fast as possible. Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 21 days.

Outcome Measures

Primary Outcome Measures

The box and block test (BBT) [One week before the training. BBT requires 2 to 5 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 box and block test (BBT) [One week after the training. BBT requires 2 to 5 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 week before the training. 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.
The Jebsen hand function test (JHFT) [One week after the training. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Hong Kong Polytechnic University

Investigators

Principal Investigator: Wei FAN (PhD student), MSc, The Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

FAN Wei, PhD Student, The Hong Kong Polytechnic University

ClinicalTrials.gov Identifier:

NCT05637593

Other Study ID Numbers:

HongKongPU21037721r_20221117

First Posted:

Dec 5, 2022

Last Update Posted:

Dec 14, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Hypokinesia

Dyskinesias

Study Results

No Results Posted as of Dec 14, 2022