Personalized Music-Enhanced Aerobic Training for Patients in Subacute Stroke Recovery
ConditionSubacute Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrịnh Minh Tú
About this trial
This study aims to evaluate the effectiveness of a personalized music-based aerobic exercise program designed specifically for inpatients in the subacute phase of stroke. All participants will receive the hospital's standard physical therapy program. In addition, the intervention group will participate in 30-minute music-based aerobic exercise sessions, 5 days per week, for a total of 6 weeks.
The aerobic exercises are gentle and adapted to the functional abilities of individuals with subacute stroke. The exercises incorporate rhythmic music to guide movements of the arms, legs, and trunk, with the goal of improving mobility, balance, and mood. Participants will have their heart rate monitored and will be supervised directly by rehabilitation therapists throughout all sessions to ensure safety.
Outcomes will be assessed before and after the 6-week intervention using standardized measures of motor function, balance, depressive symptoms, and independence in daily activities. The study does not interfere with participants' routine medical treatment and does not require discontinuation of any ongoing therapies.
Risks associated with participation are generally mild and similar to those of routine therapeutic exercise, such as muscle soreness, dizziness, or risk of falls. All potential risks will be minimized through continuous supervision by trained healthcare staff. Participants may withdraw from the study at any time.
Potential benefits for participants include improved mobility, better balance, reduced depressive symptoms, increased independence in daily living, and enhanced motivation during rehabilitation through the use of music. The study also aims to provide scientific evidence for the effectiveness of music-based aerobic exercise in stroke rehabilitation in Vietnam.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Clinically and radiologically confirmed diagnosis of subacute stroke.
Able to understand and respond to assessment questions.
No significant visual or hearing impairment.
Disqualifiers
Recent myocardial infarction or congestive heart failure.
Severe cardiac arrhythmia or resting systolic blood pressure > 200 mmHg.
Hypertrophic cardiomyopathy or severe aortic stenosis.
Musculoskeletal disorders contraindicating exercise.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Physical Therapy
BehavioralStandard inpatient physical therapy including assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes per session), and occupational therapy for activities of daily living (30 minutes per session). Training is delivered once per day, 5 days per week, for 6 weeks during hospitalization.
Aerobic Exercise With Music
BehavioralA supervised 30-minute aerobic exercise program with music, delivered 1 session per day, 5 days per week for 6 weeks, in addition to standard physical therapy. Exercises are adapted for seated or supported standing stroke patients and include breathing control, neck mobility, shoulder elevation, cross-body arm reaches, elbow, wrist and hand movements, trunk rotation, forward flexion, seated marching, supported standing arm lifts, trunk rotation, high-knee marching, and step-forward/back drills. Music tempo is phase-specific: warm-up 60-70 bpm, main session 80-110 bpm, cool-down 50-60 bpm. Heart rate is monitored with a smart wristband and limited to 60% of the individual target heart rate, calculated using the Karvonen formula.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Control Group: Standard Physical TherapyActive comparator 1 intervention
Group B: Intervention Group: Aerobic Exercise With Music + Standard Physical TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Fugl-Meyer Upper Extremity (FMA-UE) Score
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) evaluates motor function, coordination, reflexes, sensation, joint pain, and passive joint motion. Scores range from 0 to 126, with higher scores reflecting better motor recovery. This primary outcome measures the change in total FMA-UE score from baseline (T0) to 6 weeks (T1) between the intervention group (aerobic exercise with individualized music) and the control group (standard rehabilitation only).
Time frame
6 weeks after intervention2
Change in Fugl-Meyer Lower Extremity (FMA-LE) Score
The Fugl-Meyer Assessment for Lower Extremity (FMA-LE) evaluates reflexes, motor control of the hip, knee, and ankle, coordination, sensation, joint pain, and passive joint motion. Scores range from 0 to 86, with higher scores indicating better lower-limb motor recovery. This primary outcome measures the change in total FMA-LE score from baseline (T0) to 6 weeks (T1) between the intervention group (aerobic exercise with individualized music) and the control group (standard rehabilitation only).
Time frame
6 weeks after interventionSecondary outcomes
1
Change in Barthel Index Score
The Barthel Index evaluates independence in activities of daily living including feeding, bathing, dressing, toileting, continence, transfers, mobility, and stair climbing. Scores range from 0 to 100, with higher scores representing greater independence. This secondary outcome measures the change in Barthel Index from baseline (T0) to 6 weeks (T1).
Time frame
6 weeks after intervention2
Change in PHQ-9 Depression Score
The PHQ-9 assesses depressive symptoms across 9 items scored 0-3. Total scores range from 0 to 27. Higher scores reflect more severe depression. This outcome measures the change in PHQ-9 score from baseline to 6 weeks.
Time frame
6 weeks after intervention3
Change in Berg Balance Scale (BBS) Score
The Berg Balance Scale includes 14 balance tasks, each scored 0-4. Total scores range from 0 to 56, with higher scores indicating better balance. This outcome evaluates change in BBS score from baseline to 6 weeks.
Time frame
6 weeks after intervention4
Change in NIH Stroke Scale (NIHSS) Score
The NIHSS measures stroke severity including consciousness, gaze, motor strength, sensation, language, and neglect. Scores range from 0 (normal) to 42 (severe stroke). This outcome assesses the change in NIHSS score from baseline to week 6.
Time frame
6 weeks after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Trịnh Minh Tú
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor institution
Source ClinicalTrials.gov