Stroke, AcuteNCT06995092
Rhythmic Auditory Stimulation as Pre-Gait Training for Improving Balance and Weight Shifting in Rehabilitation Patients
A study testing Music therapy and Standard physiotherapy program in people with Stroke, Acute and Gait, Spastic, run by University of Malaya at 1 site in Malaysia.
Trial summary
The purpose of this study is to explore whether Rhythmic Auditory Stimulation (RAS) as pre-gait training can help improve balance, weight-shifting abilities, and overall gait performance in stroke patients undergoing rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Acute, Gait, Spastic, Attention Impaired
- What is being tested?
- Music therapy and Standard physiotherapy program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 May 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with gait impairments
- Referred to physiotherapy for rehabilitation
- Ability to provide informed consent
- Understands Bahasa Melayu or English with basic communication abilities to follow instructions during therapy sessions
Who cannot join
- Severe cognitive impairments
- Severe auditory impairments
- Severe or unstable medical conditions (e.g., uncontrolled hypertension or diabetes).
- Medications that significantly impair cognition or motor function (e.g., high-dose sedatives).
- History of neurological diseases other than stroke (eg, Parkinson's disease).
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 50603
About this study
Official title: Rhythmic Auditory Stimulation as Pre-Gait Training for Improving Balance and Weight Shifting in Rehabilitation Patients: A Feasibility Randomized Controlled Trial
The purpose of this study is to explore whether Rhythmic Auditory Stimulation (RAS) as pre-gait training can help improve balance, weight-shifting abilities, and overall gait performance in stroke patients undergoing rehabilitation.
This is a feasibility study, designed to evaluate the practicality of incorporating RAS into stroke rehabilitation programs. It aims to assess how well patients can participate in and adhere to this intervention, as well as how seamlessly it integrates with standard physiotherapy treatments typically provided to stroke patients. By examining these factors, the investigators aim to identify the resources, staff training, and planning required to implement RAS as a regular component of stroke rehabilitation in the future.
The study will also help estimate the effects of RAS on balance and gait outcomes, providing preliminary data to design a larger, more comprehensive study in the future.
Read the detailed description
Stroke is a leading cause of long-term disability worldwide, often resulting in impairments such as balance deficits and gait abnormalities, which significantly impact patients' quality of life and independence in daily functioning. Rehabilitation for individuals with gait impairments typically involves physiotherapy aimed at improving balance and weight shifting. Rhythmic Auditory Stimulation (RAS) is an evidence-based therapeutic technique that uses rhythmic cues to enhance motor control and coordination. Preliminary studies suggest that RAS can improve gait performance, but its potential as a pre-gait training intervention prior to physiotherapy sessions has not been extensively explored.
Despite a concerted effort to promote the use of music therapy in Malaysia over the last decade, structured approaches integrating RAS into local rehabilitation programs remain lacking. This contrasts with neighboring countries such as Singapore, where music therapy has gained traction as a formal therapeutic modality.
This study proposes to investigate the feasibility and potential benefits of incorporating RAS into pre-gait training for rehabilitation patients. If successful, this approach could support the integration of RAS into clinical neurorehabilitation settings, providing a scalable and accessible solution to improve balance and weight-shifting abilities, ultimately enhancing the overall effectiveness of gait-focused physiotherapy.
- Conditions
- Stroke, Acute, Gait, Spastic, Attention Impaired
- Being tested
- Music therapy, Standard physiotherapy program
- Keywords
- Music therapy, randomised controlled trial, rehabilitation, stroke, cognition, attention
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Patient will receive a 15-minute RAS session immediately before patient standard physiotherapy session. The RAS session will consist of metronome beats matched to your walking cadence. After completing the RAS sessions, patient will continue with the standard rehabilitation program as usual.
Standard physiotherapy programOther
Patient will receive the standard physiotherapy program without the RAS pre-gait training. Therapy will include sessions aimed at improving balance and gait, conducted for 15 minutes during each session. Assessments will be conducted at baseline, after completing the therapy, and during two follow-up evaluations.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patient will receive a 15-minute RAS session immediately before patient standard physiotherapy session. The RAS session will consist of metronome beats matched to your walking cadence. After completing the RAS sessions, patient will continue with the standard rehabilitation program as usual. Receives: Other: Music therapy |
| Control group | Placebo comparator | Patient will receive the standard physiotherapy program without the RAS pre-gait training. Therapy will include sessions aimed at improving balance and gait, conducted for 15 minutes during each session. Assessments will be conducted at baseline, after completing the therapy, and during two follow-up evaluations. stroke period focuses on restoring cognitive abilities such as attention, memory, executive functions, and communication. Receives: Other: Standard physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. Cut-off scores for the elderly were reported by Berg et al 1992 as follows :
A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling. A score of ≤49 indicates a risk of falls in individuals with stroke .
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 May 2025
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
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 Stroke, AcuteStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995092
- Sponsor's protocol ID
- Pre-Gait Training
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suh JH, Han SJ, Jeon SY, Kim HJ, Lee JE, Yoon TS, Chong HJ. Effect of rhythmic auditory stimulation on gait and balance in hemiplegic stroke patients. NeuroRehabilitation. 2014;34(1):193-9. doi: 10.3233/NRE-131008.
PubMed 24284453Gonzalez-Hoelling S, Bertran-Noguer C, Reig-Garcia G, Suner-Soler R. Effects of a Music-Based Rhythmic Auditory Stimulation on Gait and Balance in Subacute Stroke. Int J Environ Res Public Health. 2021 Feb 19;18(4):2032. doi: 10.3390/ijerph18042032.
PubMed 33669715Hayden R, Clair AA, Johnson G, Otto D. The effect of rhythmic auditory stimulation (RAS) on physical therapy outcomes for patients in gait training following stroke: a feasibility study. Int J Neurosci. 2009;119(12):2183-95. doi: 10.3109/00207450903152609.
PubMed 19916847Mainka S, Wissel J, Voller H, Evers S. The Use of Rhythmic Auditory Stimulation to Optimize Treadmill Training for Stroke Patients: A Randomized Controlled Trial. Front Neurol. 2018 Sep 14;9:755. doi: 10.3389/fneur.2018.00755. eCollection 2018.
PubMed 30271375Yoo GE, Kim SJ. Rhythmic Auditory Cueing in Motor Rehabilitation for Stroke Patients: Systematic Review and Meta-Analysis. J Music Ther. 2016 Summer;53(2):149-77. doi: 10.1093/jmt/thw003. Epub 2016 Apr 15.
PubMed 27084833
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythmic Auditory Stimulation as Pre-Gait Training for Improving Balance and Weight Shifting in Rehabilitation Patients: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06995092
- Acronym / sponsor ID
- Pre-Gait Training
- Conditions
- Stroke, Acute, Gait, Spastic, Attention Impaired
- Keywords
- Music therapy, randomised controlled trial, rehabilitation, stroke, cognition, attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 29 May 2025 (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.
The purpose of this study is to explore whether Rhythmic Auditory Stimulation (RAS) as pre-gait training can help improve balance, weight-shifting abilities, and overall gait performance in stroke patients undergoing rehabilitation.
This is a feasibility study, designed to evaluate the practicality of incorporating RAS into stroke rehabilitation programs. It aims to assess how well patients can participate in and adhere to this intervention, as well as how seamlessly it integrates with standard physiotherapy treatments typically provided to stroke patients. By examining these factors, the investigators aim to identify the resources, staff training, and planning required to implement RAS as a regular component of stroke rehabilitation in the future.
The study will also help estimate the effects of RAS on balance and gait outcomes, providing preliminary data to design a larger, more comprehensive study in the future.
Detailed description
Stroke is a leading cause of long-term disability worldwide, often resulting in impairments such as balance deficits and gait abnormalities, which significantly impact patients' quality of life and independence in daily functioning. Rehabilitation for individuals with gait impairments typically involves physiotherapy aimed at improving balance and weight shifting. Rhythmic Auditory Stimulation (RAS) is an evidence-based therapeutic technique that uses rhythmic cues to enhance motor control and coordination. Preliminary studies suggest that RAS can improve gait performance, but its potential as a pre-gait training intervention prior to physiotherapy sessions has not been extensively explored.
Despite a concerted effort to promote the use of music therapy in Malaysia over the last decade, structured approaches integrating RAS into local rehabilitation programs remain lacking. This contrasts with neighboring countries such as Singapore, where music therapy has gained traction as a formal therapeutic modality.
This study proposes to investigate the feasibility and potential benefits of incorporating RAS into pre-gait training for rehabilitation patients. If successful, this approach could support the integration of RAS into clinical neurorehabilitation settings, providing a scalable and accessible solution to improve balance and weight-shifting abilities, ultimately enhancing the overall effectiveness of gait-focused physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Music therapyPatient will receive a 15-minute RAS session immediately before patient standard physiotherapy session. The RAS session will consist of metronome beats matched to your walking cadence. After completing the RAS sessions, patient will continue with the standard rehabilitation program as usual. |
| Control group | Placebo comparator | Other: Standard physiotherapy programPatient will receive the standard physiotherapy program without the RAS pre-gait training. Therapy will include sessions aimed at improving balance and gait, conducted for 15 minutes during each session. Assessments will be conducted at baseline, after completing the therapy, and during two follow-up evaluations. stroke period focuses on restoring cognitive abilities such as attention, memory, executive functions, and communication. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with gait impairments
- Referred to physiotherapy for rehabilitation
- Ability to provide informed consent
- Understands Bahasa Melayu or English with basic communication abilities to follow instructions during therapy sessions
Key exclusion criteria (5 listed)
- Severe cognitive impairments
- Severe auditory impairments
- Severe or unstable medical conditions (e.g., uncontrolled hypertension or diabetes).
- Medications that significantly impair cognition or motor function (e.g., high-dose sedatives).
- History of neurological diseases other than stroke (eg, Parkinson's disease).
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 |
|---|---|---|
| Music therapyPatient will receive a 15-minute RAS session immediately before patient standard physiotherapy session. The RAS session will consist of metronome beats matched to your walking cadence. After completing the RAS sessions, patient will continue with the standard rehabilitation program as usual. | Other | Intervention group |
| Standard physiotherapy programPatient will receive the standard physiotherapy program without the RAS pre-gait training. Therapy will include sessions aimed at improving balance and gait, conducted for 15 minutes during each session. Assessments will be conducted at baseline, after completing the therapy, and during two follow-up evaluations. | Other | Control group |
Primary outcome
Berg Balance Scale (BBS)
Time frame: 3 Months
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. Cut-off scores for the elderly were reported by Berg et al 1992 as follows : A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling. A score of ≤49 indicates a risk of falls in individuals with stroke .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 24284453Suh JH, Han SJ, Jeon SY, Kim HJ, Lee JE, Yoon TS, Chong HJ. Effect of rhythmic auditory stimulation on gait and balance in hemiplegic stroke patients. NeuroRehabilitation. 2014;34(1):193-9. doi: 10.3233/NRE-131008.
- Results publication: PubMed 33669715Gonzalez-Hoelling S, Bertran-Noguer C, Reig-Garcia G, Suner-Soler R. Effects of a Music-Based Rhythmic Auditory Stimulation on Gait and Balance in Subacute Stroke. Int J Environ Res Public Health. 2021 Feb 19;18(4):2032. doi: 10.3390/ijerph18042032.
- Results publication: PubMed 19916847Hayden R, Clair AA, Johnson G, Otto D. The effect of rhythmic auditory stimulation (RAS) on physical therapy outcomes for patients in gait training following stroke: a feasibility study. Int J Neurosci. 2009;119(12):2183-95. doi: 10.3109/00207450903152609.
- Results publication: PubMed 30271375Mainka S, Wissel J, Voller H, Evers S. The Use of Rhythmic Auditory Stimulation to Optimize Treadmill Training for Stroke Patients: A Randomized Controlled Trial. Front Neurol. 2018 Sep 14;9:755. doi: 10.3389/fneur.2018.00755. eCollection 2018.
- Results publication: PubMed 27084833Yoo GE, Kim SJ. Rhythmic Auditory Cueing in Motor Rehabilitation for Stroke Patients: Systematic Review and Meta-Analysis. J Music Ther. 2016 Summer;53(2):149-77. doi: 10.1093/jmt/thw003. Epub 2016 Apr 15.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy and Standard physiotherapy program in people with Stroke, Acute and Gait, Spastic, run by University of Malaya at 1 site in Malaysia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 2 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (time frame: 3 Months). 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 NCT06995092, 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 2 Apr 2026.