Effects of RAS in Stroke

NCT06830785 | Recruiting

• 1 other identifier: RAS in stroke patients
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to to examine whether rhythmic auditory stimulation improved movement speed, movement function of executing activities of daily living, and movement recovery of the affected upper limb, as well as quality of life in stroke patients. The main questions it aims to answer are:

• Does rhythmic auditory stimulation improve movement speed in stroke patients?
• Does rhythmic auditory stimulation improve movement function of executing activities of daily living in stroke patients?
• Does rhythmic auditory stimulation improve movement recovery of the affected upper limb in stroke patients?
• Does rhythmic auditory stimulation improve quality of life in stroke patients? Researchers will compare movement training with the aid of rhythmic auditory stimulation to movement training without the aid of rhythmic auditory stimulation to see if rhythmic auditory stimulation works to improve movement speed, movement function of executing activities of daily living, and movement recovery of the affected upper limb, as well as quality of life in stroke patients. Participants will:
• Undergo movement tests and fill out questionnaires before and after the movement training program
• Receive movement training for 40 minutes per session and three sessions per week for a total of 24 sessions

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Nine-Hole Peg Test

  A larger value (the recorded time for completing the task) means a slower movement.

  Up to 1 week right before the 1st session of the intervention

• Nine-Hole Peg Test

  A larger value (the recorded time for completing the task) means a slower movement.

  Up to 1 week right after the last session of the intervention

• Box and Block Test

  A larger value (the number of blocks) means a faster movement.

  Up to 1 week right before the 1st session of the intervention

• Box and Block Test

  A larger value (the number of blocks) means a faster movement.

  Up to 1 week right after the last session of the intervention

Secondary Outcomes (6)

• Jebsen-Taylor Hand Function Test

  Up to 1 week right before the 1st session of the intervention

• Jebsen-Taylor Hand Function Test

  Up to 1 week right after the last session of the intervention

• the Fugl-Meyer Assessment

  Up to 1 week right before the 1st session of the intervention

• the Fugl-Meyer Assessment

  Up to 1 week right after the last session of the intervention

• the Stroke Impact Scale

  Up to 1 week right before the 1st session of the intervention

Study Arms (2)

Experiment group

EXPERIMENTAL

provision of rhythmic auditory stimulation

Behavioral: rhythmic auditory stimulation incorporated in upper-limb movement training

Control Group

ACTIVE COMPARATOR

no provision of rhythmic auditory stimulation

Behavioral: Upper-limb movement training

Interventions

rhythmic auditory stimulation incorporated in upper-limb movement training BEHAVIORAL

Rhythmic auditory stimulation will be metronome beat sound with different tempi and will be incorporated in upper-limb movement training, which will last for 40 minutes per session, three sessions per week, and a total of 24 sessions.

Experiment group

Upper-limb movement training BEHAVIORAL

Upper-limb movement training will last for 40 minutes per session, three sessions per week, and a total of 24 sessions.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Diagnosed with either ischaemic or hemorrhagic stroke, and a first-time occurrence;
• (2) A unilateral stroke;
• (3) The onset occurred six months or more prior to the experiment, indicating a chronic stage of stroke;
• (4) The affected upper limb's proximal and distal joints are between Brunnstrom stages four to six, ensuring that the affected limb can execute the upper-limb functional movement training of this study;
• (5) The affected upper limb's Modified Ashworth Scale score is ≤ 2, indicating no significant muscle stiffness (spasticity) in the affected limb;
• (6) A Montreal Cognitive Assessment score of ≥ 24, ensuring comprehension of the instructions given during this study;
• and (7) when we clap hands next to the affected ear of the participant who closes eyes, the participant is able to indicate the sound's source either verbally or through gestures, indicating no complete hearing loss in the affected ear and the ability to receive rhythmic auditory stimulation.

You may not qualify if:

• (1) Neurological diseases or medical conditions that affect upper-limb movements or hearing;
• (2) Being participating in other experimental studies related to drug treatment or upper-limb movement therapy.

Sponsors & Collaborators

• Shu-Mei Wang: lead

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)