Clinical trial NCT06830785: Effects of RAS in Stroke
Official title: Effects of Rhythmic Auditory Stimulation on Upper-limb Movements, Function, and Quality of Life in Stroke Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 68
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 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


Eligibility criteria: 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.

Primary outcomes:
measure: Nine-Hole Peg Test
timeFrame: Up to 1 week right before the 1st session of the intervention
measure: Nine-Hole Peg Test
timeFrame: Up to 1 week right after the last session of the intervention
measure: Box and Block Test
timeFrame: Up to 1 week right before the 1st session of the intervention
measure: Box and Block Test
timeFrame: Up to 1 week right after the last session of the intervention
Secondary outcomes:
measure: Jebsen-Taylor Hand Function Test
timeFrame: Up to 1 week right before the 1st session of the intervention
measure: Jebsen-Taylor Hand Function Test
timeFrame: Up to 1 week right after the last session of the intervention
measure: the Fugl-Meyer Assessment
timeFrame: Up to 1 week right before the 1st session of the intervention
measure: the Fugl-Meyer Assessment
timeFrame: Up to 1 week right after the last session of the intervention
measure: the Stroke Impact Scale
timeFrame: Up to 1 week right before the 1st session of the intervention
measure: the Stroke Impact Scale
timeFrame: Up to 1 week right after the last session of the intervention
Other outcomes:
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