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临床试验/CTRI/2024/10/074832
CTRI/2024/10/074832尚未招募2 期

Music-based interventions for improving upper extremity functions in patients with Parkinsons Disease: A Randomized controlled trial

Christian Medical College1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年10月18日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
75
试验地点
1
主要终点
1.Gross Dexterity - Box and Block Test

研究概览

简要总结

Parkinson’s disease (PD) is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms that significantly impact an individual’s functional abilities and quality of life. Among the motor symptoms, upper limb dysfunctions, including impaired dexterity, coordination, and fine motor control, is a common and debilitating feature of PD. These deficits can have a profound impact on the performance of ADLs and self-care, leading to increased dependence and reduced independence.

Existing rehabilitation approaches, such as Occupational Therapy, have focused on addressing these upper limb impairments through various therapeutic techniques and exercises. However, alternative approaches, such as Neurological music therapy (NMT), have gained increasing attention in recent years.

NMT is a specialized form of music therapy that utilizes the therapeutic application of music to address sensory-motor, cognitive, and psycho-social needs associated with neurological disorders.

Previous studies have demonstrated the efficacy of PSE and RAS in improving gait and upper limb function in individuals with neurological conditions, such as stroke and traumatic brain injury.

However, their application and efficacy in improving upper limb function in individuals with PD have not been extensively explored.

This study aims to compare the efficacy of PSE, RAS, and usual OT in improving upper limb functions in patients with PD. By evaluating the feasibility and effectiveness of these interventions, this study will contribute to the growing body of knowledge on the use of music-based interventions in the rehabilitation of PD patients.

This will be a single-blinded, randomized controlled trial with three parallel arms: PSE group, RAS group, and usual OT group. The primary outcome measures will be the Box and Block Test, Purdue Peg board Test, and Action Research Arm Test. Secondary outcomes will include the Unified Parkinson’s Disease Rating Scale (UPDRS) for activities of daily living. Participants will be randomly allocated to receive either PSE with usual OT, RAS with usual OT, or usual OT alone for 3 weeks (1 week hospital-based and 2 weeks home-based). Assessments will be conducted at baseline and post-intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age more than 18 years Both genders Hoehn & Yahr stage 2 or stage 3 Able to comprehend instructions (MoCA score more than 21) Stable antiparkinsonian drug treatment in the past one month Participants willing to give consent Able to attend 1 week of hospital-based therapy sessions Has a caregiver available to assist with setting up the home training environment for the 2-week home program.

排除标准

  • Presence of other neurological and orthopedic medical conditions that affect hand functions Participants with any visual or auditory impairment Participants engaged in other research studies involving music Participants with complaints of migraine Participants who are not willing to give consent.

结局指标

主要结局

1.Gross Dexterity - Box and Block Test

时间窗: 1. Baseline | 2. After 3 weeks

2.Fine Dexterity - Purdue Peg Board Test

时间窗: 1. Baseline | 2. After 3 weeks

3.Hand Function - Action Research Arm Test

时间窗: 1. Baseline | 2. After 3 weeks

次要结局

  • ADL- MDS-UPDRS(1. Baseline)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Partha sarathi Mohanty

Christian medical college

研究点 (1)

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