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Recruiting NCT06830785

Effects of RAS in Stroke

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rhythmic auditory stimulation incorporated in upper-limb movement training, Upper-limb movement training.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Behavioral rhythmic auditory stimulation incorporated in upper-limb movement training
    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.
  • Behavioral Upper-limb movement training
    Upper-limb movement training will last for 40 minutes per session, three sessions per week, and a total of 24 sessions.

Primary outcome measures

  • Nine-Hole Peg Test [Time frame: Up to 1 week right before the 1st session of the intervention]
  • Nine-Hole Peg Test [Time frame: Up to 1 week right after the last session of the intervention]
  • Box and Block Test [Time frame: Up to 1 week right before the 1st session of the intervention]
  • Box and Block Test [Time frame: Up to 1 week right after the last session of the intervention]
Secondary outcome measures (6)
  • Jebsen-Taylor Hand Function Test [Time frame: Up to 1 week right before the 1st session of the intervention]
  • Jebsen-Taylor Hand Function Test [Time frame: Up to 1 week right after the last session of the intervention]
  • the Fugl-Meyer Assessment [Time frame: Up to 1 week right before the 1st session of the intervention]
  • the Fugl-Meyer Assessment [Time frame: Up to 1 week right after the last session of the intervention]
  • the Stroke Impact Scale [Time frame: Up to 1 week right before the 1st session of the intervention]
  • the Stroke Impact Scale [Time frame: Up to 1 week right after the last session of the intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taipei University of Nursing and Health Sciences — Taipei

Identifiers

NCT: NCT06830785 · RAS in stroke patients

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗