Rhythmic Auditory Stimulaton Using Personalized Music Therapy in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Freezing of Gait
研究概览
简要总结
Parkinson's disease (PD) is a progressive neurodegenerative disorder commonly associated with gait disturbances, balance impairments, and freezing of gait, which significantly increase the risk of falls and reduce functional independence. Conventional physical therapy improves mobility in individuals with PD; however, persistent gait deficits often remain. Rhythmic Auditory Stimulation (RAS) is an emerging, evidence-based intervention that uses external auditory cues to enhance gait timing, stride length, and movement initiation.
This randomized controlled trial aims to evaluate the effectiveness of rhythmic auditory stimulation using personalized music therapy combined with conventional physical therapy compared to conventional physical therapy alone in individuals with Parkinson's disease. The primary outcomes include freezing of gait, gait velocity, and balance performance. Forty-two clinically diagnosed Parkinson's disease patients will be randomly allocated into two groups. Group A will receive conventional physical therapy, while Group B will receive rhythmic auditory stimulation using personalized music in addition to conventional therapy over an 8-week intervention period.
The findings of this study may provide clinical evidence supporting the integration of personalized rhythmic auditory stimulation into rehabilitation programs for improving gait and balance in individuals with Parkinson's disease.
详细描述
Parkinson's disease is characterized by progressive impairments in motor control, including bradykinesia, rigidity, postural instability, and freezing of gait. Among these, freezing of gait and balance dysfunction are particularly disabling, as they interfere with safe ambulation and daily activities. Despite pharmacological management, gait and balance impairments often persist, necessitating effective rehabilitative strategies.
Rhythmic Auditory Stimulation (RAS) is a neurologic music therapy technique that provides rhythmic external cues to facilitate movement coordination through auditory-motor entrainment. Auditory cues, particularly when synchronized with an individual's natural walking cadence, have been shown to improve gait initiation, stride length, walking speed, and movement regularity in patients with Parkinson's disease. Personalized music-based RAS may further enhance adherence, motivation, and motor performance compared to non-personalized auditory cues.
This randomized controlled trial will be conducted at University of Lahore Teaching Hospital and Shadman Medical Center, Lahore, over a duration of nine months following ethical approval. A total of 42 patients diagnosed with Parkinson's disease according to Queen Square Brain Bank criteria will be recruited using a purposive sampling technique and randomly allocated into two equal groups through computer-generated randomization.
Both groups will receive treatment three times per week for eight weeks (24 sessions). Group A will undergo a conventional physical therapy program focusing on warm-up activities, stretching, balance training, gait training, and strengthening exercises. Group B will receive rhythmic auditory stimulation using personalized music synchronized to the participant's walking cadence in addition to the same conventional physical therapy protocol.
Outcome measures will be assessed at baseline and at the end of the 8-week intervention period. The primary outcome variables include freezing of gait, gait velocity, and balance management. Data will be analyzed using SPSS version 24, with appropriate parametric or non-parametric statistical tests applied based on data distribution. A p-value of ≤ 0.05 will be considered statistically significant.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the Queen Square Brain Bank standard , clinical diagnosed patients of PD Both male and females ages 45-55 The mini mental state examination scale MMSE screening without severe cognitive impairment,can cooperate with this study > 23 Mild bergs balance scale BBS score (21-40 ) score
排除标准
- •A history of neoplasms; severe cardiovascular, respiratory, visual, auditory, andmuscular-skeletal disease; other neurological conditions; and neurologic music therapy inthelast3 months.
- •Other disorders that could potentially influence balance and walking.
研究组 & 干预措施
group A Conventional physical therapy
Participants in Group A will receive conventional physical therapy for Parkinson's disease. The intervention will be delivered three times per week for eight weeks and will include warm-up activities, stretching, balance training, gait training, and lower-limb strengthening exercises. Outcomes will be assessed at baseline and after completion of the intervention period.
干预措施: conventional physical therapy (Behavioral)
group B Rhythmic Auditory Stimulation with Personalized Music
Participants in Group B will receive rhythmic auditory stimulation using personalized music synchronized to individual gait cadence, in addition to conventional physical therapy. The intervention will be administered three times per week for eight weeks. Conventional therapy will include warm-up exercises, stretching, balance training, gait training, and strengthening. Outcome measures will be assessed at baseline and after completion of the intervention period.
干预措施: Rhythmic Auditory Stimulation (RAS) (Behavioral)
结局指标
主要结局
Freezing of Gait
时间窗: Baseline and after 8 weeks of intervention
Freezing of gait will be assessed using the Freezing of Gait Questionnaire (FOGQ), a validated patient-reported outcome measure designed to quantify the frequency and severity of freezing episodes during walking, turning, and gait initiation in individuals with Parkinson's disease. Higher scores indicate greater severity of freezing of gait.
次要结局
- Balance Performance(Baseline and after 8 weeks of intervention)
研究者
Rumesa Butt
principal investigator
University of Lahore