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Completed

NCT Number: NCT06995092

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

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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Key information

Conditions

Stroke, Acute Attention Impaired Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Gait, Spastic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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 .

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 29, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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