Subacute StrokeAMPER-StrokeNCT07503522
Personalized Music-Enhanced Aerobic Training for Patients in Subacute Stroke Recovery
A study testing Standard Physical Therapy and Aerobic Exercise With Music in people with Subacute Stroke, run by Trịnh Minh Tú at 1 site in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacute Stroke
- What is being tested?
- Standard Physical Therapy and Aerobic Exercise With Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Apr 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Mini-Mental State Examination (MMSE) ≥ 10.
- Able to sit unsupported.
- Provided informed consent (patient or legal representative).
Who cannot join
- 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.
- Psychiatric disorders interfering with participation.
- Severe aphasia preventing assessment.
- Moderate-to-severe dementia (MMSE ≤ 9).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Ho Chi Minh City Orthopedics and Rehabilitation Hospital (Hospital 1A)
Ho Chi Minh City, Ho Chi Minh, 700157
Minh Tu Trinh, MD, +84947969399, tmtu.ncs25@ump.edu.vn
About this study
Official title: Evaluation of the Effectiveness of a Personalized Music-Based Aerobic Exercise Rehabilitation Program for Patients With Subacute Stroke
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.
Read more
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.
Read the detailed description
Subacute stroke represents a critical window for neurological recovery, during which neuroplasticity is heightened and rehabilitation interventions may have a stronger impact on long-term functional outcomes. Despite receiving standard inpatient rehabilitation, many patients continue to experience persistent limitations in mobility, balance, and emotional well-being. There is growing evidence that aerobic exercise can enhance neuroplasticity, improve cardiovascular fitness, and support motor relearning during stroke recovery. Music-based rehabilitation approaches, including rhythmic auditory stimulation, have also been shown to facilitate coordinated movement, increase engagement, and positively influence mood.
However, most aerobic exercise protocols studied internationally-such as treadmill walking, stationary cycling, or moderate-to-high intensity regimens-are not feasible for many patients in the subacute phase because of weakness, impaired balance, or restricted mobility. There is a need for accessible, adaptable, and lower-intensity aerobic interventions that can be delivered safely during inpatient rehabilitation without requiring specialized equipment.
This study was designed to address this gap by developing a structured music-based aerobic exercise program tailored to the physical capacity of individuals with subacute stroke. The intervention incorporates rhythmic music with clear tempo cues to support timing, pacing, and coordination of limb and trunk movements. The exercise sequence includes warm-up, rhythmic aerobic movements, and cool-down, and may be performed in either a seated or supported standing position depending on each participant's functional ability. Music selections are chosen to provide stable rhythm, moderate tempo, and a motivating emotional tone, which may enhance participation and therapeutic engagement.
The trial uses a randomized controlled design to investigate whether adding this structured music-based aerobic program to standard inpatient rehabilitation produces additional improvements over a 6-week period. The conceptual foundation for this intervention draws from principles of neurologic music therapy, aerobic conditioning guidelines for individuals post-stroke, and emerging evidence that music can improve movement synchronization, attentional focus, and emotional regulation.
Safety is an integral component of the study design. The intervention was created specifically to avoid complex or destabilizing movements and to remain within a mild-to-moderate intensity range appropriate for subacute stroke patients. Continuous supervision by rehabilitation therapists and monitoring of vital signs aim to ensure that the program remains safe and well tolerated. The study also includes procedures for identifying, documenting, and managing adverse events and for adjusting the protocol as necessary to maintain participant safety.
By evaluating this structured, culturally adapted music-based aerobic program within an inpatient setting, the study aims to generate practical evidence on its feasibility, safety, and potential therapeutic value. The findings may help guide future recommendations for incorporating rhythmic and music-based interventions into early stroke rehabilitation and may contribute to the development of rehabilitation protocols that are more engaging, motivating, and tailored to patient needs within the Vietnamese healthcare context.
- Conditions
- Subacute Stroke
- Being tested
- Standard Physical Therapy, Aerobic Exercise With Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physical TherapyBehavioural
Standard 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 MusicBehavioural
A 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Standard Physical Therapy | Active comparator | Participants in the control arm will receive the standard inpatient physical therapy program routinely applied at the hospital. The standard physical therapy includes assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes per session), and occupational therapy exercises for activities of daily living (30 minutes per session). Training is conducted by certified physiotherapists, 1 session/day, 5 days/week, for 6 consecutive weeks during hospitalization. No aerobic exercise with music is provided in this arm. Receives: Behavioral: Standard Physical Therapy |
| Intervention Group: Aerobic Exercise With Music + Standard Physical Therapy | Experimental | Participants receive the standard inpatient physical therapy program, including assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes/session), and occupational therapy for activities of daily living (30 minutes/session). In addition, they complete a 30-minute supervised aerobic exercise program with music, 1 session/day, 5 days/week for 6 weeks. Exercises include breathing control, neck mobility, shoulder elevation, cross-body arm reaches, elbow, wrist and hand movements, trunk rotation, forward flexion, seated marching, and 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, with intensity limited to 60% of the individual target heart rate calculated using the Karvonen formula. Receives: Behavioral: Standard Physical Therapy; Behavioral: Aerobic Exercise With Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks after intervention
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).
Measured: 6 weeks after intervention
Secondary outcomes (6)
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).
Measured: 6 weeks after intervention
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.
Measured: 6 weeks after intervention
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.
Measured: 6 weeks after intervention
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.
Measured: 6 weeks after intervention
Change in Mini-Mental State Examination (MMSE) Score
The MMSE evaluates global cognition including orientation, attention, memory, language, and visuospatial skills. Scores range from 0 to 30. This outcome assesses change in MMSE score from baseline to 6 weeks.
Measured: 6 weeks after intervention
Exercise-Related Adverse Events
Adverse events include dizziness, falls, hypoglycemia, muscle pain, or other symptoms that prevent continuation of aerobic exercise. All events will be recorded throughout the 6-week intervention period.
Measured: During the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Apr 2026
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Subacute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the intervention group or the control group in a parallel design. The control group will receive standard physical therapy, while the intervention group will receive standard therapy plus a music-based aerobic exercise program. Randomization is conducted through block randomization with permuted block size. Both groups will be followed concurrently for 6 weeks
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trịnh Minh Tú
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Trịnh Minh Tú, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Minh Tu Trinh, MD, Principal investigator, Ho Chi Minh City Orthopedics and Rehabilitation Hospital (Hospital 1A)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503522
- Sponsor's protocol ID
- AERO-MUSIC-STROKE-HCMC-01
- Acronym
- AMPER-Stroke
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset contains personal health information of patients and cannot be shared publicly under institutional and national privacy regulations. Only aggregated, de-identified results will be reported.
Publications
Dimitriadis T, Mudarris MA, Veldhuijzen DS, Evers AWM, Magee WL, Schaefer RS. Music therapy with adults in the subacute phase after stroke: A study protocol. Contemp Clin Trials Commun. 2024 Jul 25;41:101340. doi: 10.1016/j.conctc.2024.101340. eCollection 2024 Oct.
PubMed 39188414Moncion K, Rodrigues L, Wiley E, Noguchi KS, Negm A, Richardson J, MacDonald MJ, Roig M, Tang A. Aerobic exercise interventions for promoting cardiovascular health and mobility after stroke: a systematic review with Bayesian network meta-analysis. Br J Sports Med. 2024 Mar 21;58(7):392-400. doi: 10.1136/bjsports-2023-107956.
PubMed 38413134Gonzalez-Hoelling S, et al. Effects of rhythmic auditory stimulation on gait and balance in subacute stroke: A randomized controlled trial. NeuroRehabilitation. 2021;48(1):45-57.
MacKay-Lyons M, Billinger SA, Eng JJ, Dromerick A, Giacomantonio N, Hafer-Macko C, Macko R, Nguyen E, Prior P, Suskin N, Tang A, Thornton M, Unsworth K. Aerobic Exercise Recommendations to Optimize Best Practices in Care After Stroke: AEROBICS 2019 Update. Phys Ther. 2020 Jan 23;100(1):149-156. doi: 10.1093/ptj/pzz153.
PubMed 31596465Mang CS, Campbell KL, Ross CJ, Boyd LA. Promoting neuroplasticity for motor rehabilitation after stroke: considering the effects of aerobic exercise and genetic variation on brain-derived neurotrophic factor. Phys Ther. 2013 Dec;93(12):1707-16. doi: 10.2522/ptj.20130053. Epub 2013 Aug 1.
PubMed 23907078
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Personalized Music-Based Aerobic Exercise Rehabilitation Program for Patients With Subacute Stroke
- ClinicalTrials.gov ID
- NCT07503522
- Acronym / sponsor ID
- AMPER-Stroke / AERO-MUSIC-STROKE-HCMC-01
- Conditions
- Subacute Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Trịnh Minh TúUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subacute stroke represents a critical window for neurological recovery, during which neuroplasticity is heightened and rehabilitation interventions may have a stronger impact on long-term functional outcomes. Despite receiving standard inpatient rehabilitation, many patients continue to experience persistent limitations in mobility, balance, and emotional well-being. There is growing evidence that aerobic exercise can enhance neuroplasticity, improve cardiovascular fitness, and support motor relearning during stroke recovery. Music-based rehabilitation approaches, including rhythmic auditory stimulation, have also been shown to facilitate coordinated movement, increase engagement, and positively influence mood.
However, most aerobic exercise protocols studied internationally-such as treadmill walking, stationary cycling, or moderate-to-high intensity regimens-are not feasible for many patients in the subacute phase because of weakness, impaired balance, or restricted mobility. There is a need for accessible, adaptable, and lower-intensity aerobic interventions that can be delivered safely during inpatient rehabilitation without requiring specialized equipment.
This study was designed to address this gap by developing a structured music-based aerobic exercise program tailored to the physical capacity of individuals with subacute stroke. The intervention incorporates rhythmic music with clear tempo cues to support timing, pacing, and coordination of limb and trunk movements. The exercise sequence includes warm-up, rhythmic aerobic movements, and cool-down, and may be performed in either a seated or supported standing position depending on each participant's functional ability. Music selections are chosen to provide stable rhythm, moderate tempo, and a motivating emotional tone, which may enhance participation and therapeutic engagement.
The trial uses a randomized controlled design to investigate whether adding this structured music-based aerobic program to standard inpatient rehabilitation produces additional improvements over a 6-week period. The conceptual foundation for this intervention draws from principles of neurologic music therapy, aerobic conditioning guidelines for individuals post-stroke, and emerging evidence that music can improve movement synchronization, attentional focus, and emotional regulation.
Safety is an integral component of the study design. The intervention was created specifically to avoid complex or destabilizing movements and to remain within a mild-to-moderate intensity range appropriate for subacute stroke patients. Continuous supervision by rehabilitation therapists and monitoring of vital signs aim to ensure that the program remains safe and well tolerated. The study also includes procedures for identifying, documenting, and managing adverse events and for adjusting the protocol as necessary to maintain participant safety.
By evaluating this structured, culturally adapted music-based aerobic program within an inpatient setting, the study aims to generate practical evidence on its feasibility, safety, and potential therapeutic value. The findings may help guide future recommendations for incorporating rhythmic and music-based interventions into early stroke rehabilitation and may contribute to the development of rehabilitation protocols that are more engaging, motivating, and tailored to patient needs within the Vietnamese healthcare context.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the intervention group or the control group in a parallel design. The control group will receive standard physical therapy, while the intervention group will receive standard therapy plus a music-based aerobic exercise program. Randomization is conducted through block randomization with permuted block size. Both groups will be followed concurrently for 6 weeks
| Arm | Type | Receives |
|---|---|---|
| Control Group: Standard Physical Therapy | Active comparator | Behavioral: Standard Physical TherapyParticipants in the control arm will receive the standard inpatient physical therapy program routinely applied at the hospital. The standard physical therapy includes assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes per session), and occupational therapy exercises for activities of daily living (30 minutes per session). Training is conducted by certified physiotherapists, 1 session/day, 5 days/week, for 6 consecutive weeks during hospitalization. No aerobic exercise with music is provided in this arm. |
| Intervention Group: Aerobic Exercise With Music + Standard Physical Therapy | Experimental | Behavioral: Standard Physical Therapy, Behavioral: Aerobic Exercise With MusicParticipants receive the standard inpatient physical therapy program, including assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes/session), and occupational therapy for activities of daily living (30 minutes/session). In addition, they complete a 30-minute supervised aerobic exercise program with music, 1 session/day, 5 days/week for 6 weeks. Exercises include breathing control, neck mobility, shoulder elevation, cross-body arm reaches, elbow, wrist and hand movements, trunk rotation, forward flexion, seated marching, and 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, with intensity limited to 60% of the individual target heart rate calculated using the Karvonen formula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Mini-Mental State Examination (MMSE) ≥ 10.
Key exclusion criteria (7 listed)
- 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.
- Psychiatric disorders interfering with participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Physical TherapyStandard 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. | Behavioural | Control Group: Standard Physical Therapy, Intervention Group: Aerobic Exercise With Music + Standard Physical Therapy |
| Aerobic Exercise With MusicA 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. | Behavioural | Intervention Group: Aerobic Exercise With Music + Standard Physical Therapy |
Primary outcome
Change in Fugl-Meyer Upper Extremity (FMA-UE) Score
Time frame: 6 weeks after intervention
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).
Change in Fugl-Meyer Lower Extremity (FMA-LE) Score
Time frame: 6 weeks after intervention
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).
6 secondary outcomes
Change in Barthel Index Score
Time frame: 6 weeks after intervention
Change in PHQ-9 Depression Score
Time frame: 6 weeks after intervention
Change in Berg Balance Scale (BBS) Score
Time frame: 6 weeks after intervention
Change in NIH Stroke Scale (NIHSS) Score
Time frame: 6 weeks after intervention
Change in Mini-Mental State Examination (MMSE) Score
Time frame: 6 weeks after intervention
Exercise-Related Adverse Events
Time frame: During the 6-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 39188414Dimitriadis T, Mudarris MA, Veldhuijzen DS, Evers AWM, Magee WL, Schaefer RS. Music therapy with adults in the subacute phase after stroke: A study protocol. Contemp Clin Trials Commun. 2024 Jul 25;41:101340. doi: 10.1016/j.conctc.2024.101340. eCollection 2024 Oct.
- Background: PubMed 38413134Moncion K, Rodrigues L, Wiley E, Noguchi KS, Negm A, Richardson J, MacDonald MJ, Roig M, Tang A. Aerobic exercise interventions for promoting cardiovascular health and mobility after stroke: a systematic review with Bayesian network meta-analysis. Br J Sports Med. 2024 Mar 21;58(7):392-400. doi: 10.1136/bjsports-2023-107956.
- BackgroundGonzalez-Hoelling S, et al. Effects of rhythmic auditory stimulation on gait and balance in subacute stroke: A randomized controlled trial. NeuroRehabilitation. 2021;48(1):45-57.
- Background: PubMed 31596465MacKay-Lyons M, Billinger SA, Eng JJ, Dromerick A, Giacomantonio N, Hafer-Macko C, Macko R, Nguyen E, Prior P, Suskin N, Tang A, Thornton M, Unsworth K. Aerobic Exercise Recommendations to Optimize Best Practices in Care After Stroke: AEROBICS 2019 Update. Phys Ther. 2020 Jan 23;100(1):149-156. doi: 10.1093/ptj/pzz153.
- Background: PubMed 23907078Mang CS, Campbell KL, Ross CJ, Boyd LA. Promoting neuroplasticity for motor rehabilitation after stroke: considering the effects of aerobic exercise and genetic variation on brain-derived neurotrophic factor. Phys Ther. 2013 Dec;93(12):1707-16. doi: 10.2522/ptj.20130053. Epub 2013 Aug 1.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset contains personal health information of patients and cannot be shared publicly under institutional and national privacy regulations. Only aggregated, de-identified results will be reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minh Tu Trinh, MD principal investigator
Ho Chi Minh City Orthopedics and Rehabilitation Hospital (Hospital 1A)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Physical Therapy and Aerobic Exercise With Music in people with Subacute Stroke, run by Trịnh Minh Tú at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minh Tu Trinh, MD (+84947969399, tmtu.ncs25@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Upper Extremity (FMA-UE) Score (time frame: 6 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503522, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.