Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07378722

Rhythmic Auditory Stimulaton Using Personalized Music Therapy in Parkinson's Disease

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Rumesa Butt · Academic / Other
Sex
All
Age
45 Years – 55 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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. This study aims to provide high-quality clinical evidence regarding the effectiveness of rhythmic auditory stimulation using personalized music therapy as an adjunct to conventional physical therapy in improving gait and balance outcomes in individuals with Parkinson's disease.

Conditions

Interventions

TypeNameDescription
BEHAVIORALconventional physical therapyGROUP A This group will receive the conventional physical therapy protocol for 8 weeks, they will receive treatment 3 times a week and the readings will be takenat baseline and at the end of 8 weeks of treatment. Total treatment sessions will be 24
BEHAVIORALRhythmic Auditory Stimulation (RAS)Rhythmic Auditory Stimulation (RAS) will be delivered using personalized music selected according to each participant's preferred genre and synchronized to their individual walking cadence. Auditory cues will be provided through rhythmic music or a metronome embedded within the music to facilitate temporal gait regulation and motor entrainment. During gait training, participants will be instructed to synchronize their steps with the rhythmic auditory cues while walking overground. The RAS intervention will be administered three sessions per week for eight weeks, with each session lasting approximately 15-20 minutes and integrated into a conventional physical therapy program. The tempo of auditory cues will be adjusted progressively based on individual performance to encourage improvements in gait initiation, stride consistency, walking velocity, and reduction in freezing episodes. This intervention is designed to enhance gait automaticity and balance control in individuals with Parki

Timeline

Start date
2026-02-05
Primary completion
2026-04-05
Completion
2026-04-06
First posted
2026-01-30
Last updated
2026-01-30

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT07378722. Inclusion in this directory is not an endorsement.