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NCT Number: NCT06830785

Effects of RAS in Stroke

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taipei University of Nursing and Health Sciences

Taipei, Taiwan

Location status: Recruiting

Location contact

Shu-Mei Wang

CONTACT

[email protected]

+886-2-28227101 ext.1289

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Nine-Hole Peg Test

    Time frame: Up to 1 week right before the 1st session of the intervention

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

  2. Nine-Hole Peg Test

    Time frame: Up to 1 week right after the last session of the intervention

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

  3. Box and Block Test

    Time frame: Up to 1 week right before the 1st session of the intervention

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

  4. Box and Block Test

    Time frame: Up to 1 week right after the last session of the intervention

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

Secondary outcomes

  1. Jebsen-Taylor Hand Function Test

    Time frame: Up to 1 week right before the 1st session of the intervention

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

  2. Jebsen-Taylor Hand Function Test

    Time frame: Up to 1 week right after the last session of the intervention

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

  3. the Fugl-Meyer Assessment

    Time frame: Up to 1 week right before the 1st session of the intervention

    A higher value means better movement recovery.

  4. the Fugl-Meyer Assessment

    Time frame: Up to 1 week right after the last session of the intervention

    A higher value means better movement recovery.

  5. the Stroke Impact Scale

    Time frame: Up to 1 week right before the 1st session of the intervention

    A larger value means better quality of life.

  6. the Stroke Impact Scale

    Time frame: Up to 1 week right after the last session of the intervention

    A larger value means better quality of life.

Sponsors and collaborators

Lead sponsor

Shu-Mei Wang

Other

Registry information

Official study title

Effects of Rhythmic Auditory Stimulation on Upper-limb Movements, Function, and Quality of Life in Stroke Patients: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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