Rhythmic Auditory Stimulation as Pre-Gait Training for Improving Balance and Weight Shifting in Rehabilitation Patients

NCT06995092 — Not applicable, Completed, 27 participants, University of Malaya

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Rhythmic Auditory Stimulation as Pre-Gait Training for Improving Balance and Weight Shifting in Rehabilitation Patients: A Feasibility Randomized Controlled Trial

RegistryNCT06995092
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment27 (Actual)
SponsorUniversity of Malaya (Other)
ConditionsStroke, Acute, Gait, Spastic, Attention Impaired
InterventionsMusic therapy, Standard physiotherapy program (Other)
Datesstart 2025-05-01, primary completion 2025-07-31, completion 2025-09-30, first posted 2025-05-29, last updated 2026-04-02
Locations1 site in Malaysia

Related Papers Related Patents Related Grants Related Experts
All trials for Stroke, Acute All trials for Gait, Spastic All trials of Music therapy All trials of Standard physiotherapy program

-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.

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Intervention groupExperimentalOther: 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 groupPlacebo comparatorOther: 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.
  • Music therapy (Other): 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 program (Other): 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.

+Outcome measures

Primary outcomes

  • Berg Balance Scale (BBS) [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 .

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

+Locations (1)

FacilityCityCountryStatus
Universiti Malaya Medical CentreKuala Lumpur, Kuala LumpurMalaysia

+Publications

  • Results publication: 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. PMID 24284453
  • Results publication: Gonzalez-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. PMID 33669715
  • Results publication: Hayden 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. PMID 19916847
  • Results publication: Mainka 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. PMID 30271375
  • Results publication: Yoo 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. PMID 27084833