Rhythmic Auditory Stimulation as Pre-Gait Training for Improving Balance and Weight Shifting in Rehabilitation Patients: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant - Randomised by Principal Investigator Care Provider - Music Therapist Investigator - Rehabilitation Specialist Outcome Assessor - Neuropsychologist
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Intervention group
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.
干预措施: Music therapy (Other)
Control group
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.
干预措施: Standard physiotherapy program (Other)
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: 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 .
次要结局
未报告次要终点