NCT07378722

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 23, 2026

Last Update Submit

January 23, 2026

Conditions

Parkinson s Disease

Keywords

Parkinson's diseaseRhythmic auditory stimulationPersonalized music therapyFreezing of gait

Outcome Measures

Primary Outcomes (1)

  • Freezing of Gait

    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.

    Baseline and after 8 weeks of intervention

Secondary Outcomes (1)

  • Balance Performance

    Baseline and after 8 weeks of intervention

Study Arms (2)

group A Conventional physical therapy

ACTIVE COMPARATOR

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.

Behavioral: conventional physical therapy

group B Rhythmic Auditory Stimulation with Personalized Music

EXPERIMENTAL

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.

Behavioral: Rhythmic Auditory Stimulation (RAS)

Interventions

Rhythmic Auditory Stimulation (RAS)BEHAVIORAL

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

group B Rhythmic Auditory Stimulation with Personalized Music
conventional physical therapyBEHAVIORAL

GROUP 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

group A Conventional physical therapy

Eligibility Criteria

Age45 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shadman Medical Center

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Rumesa Aslam, MSPTN

    The University of Lahore, Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rumesa Butt, MSPTN

CONTACT

03044020918rumesaaslam5@gmail.com

Montiha Azeem, MSPTN

CONTACT

03479717317muntahaazeem9@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start

February 5, 2026

Primary Completion

April 5, 2026

Study Completion

April 6, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)