Rhythmic Auditory Gait Training for Parkinson's Disease

Overseen By Mike Lewek, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must be taking: Levodopa

Disqualifiers: Cognitive deficits, Deep brain stimulation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 4 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how using a metronome can help people with Parkinson's disease improve their walking. It tests whether stepping to a beat can enhance step size and speed, both on a treadmill and on the ground. Participants are divided into three groups: one using slow and fast beats, one using a steady beat, and one without any beats. It is suitable for those with Parkinson's who can walk independently for 10 minutes but have difficulty with smooth walking. As an unphased trial, this study provides a unique opportunity to explore innovative methods to enhance mobility.

Will I have to stop taking my current medications?

The trial requires that participants stay on stable doses of orally-administered levodopa, so you will not need to stop taking this medication.

What prior data suggests that this method is safe for people with Parkinson's disease?

Research has shown that rhythmic auditory stimulation (RAS), as used in dTRAC and TRAC, is safe for people with Parkinson's disease. Studies have found that RAS can enhance walking by increasing speed and step length. One study demonstrated that RAS improved movement and quality of life for Parkinson’s patients. Another study noted that rhythmic sounds enhanced stepping speed and distance.

Testing the use of a metronome for walking practice in different groups has revealed no serious side effects, suggesting that the treatment is generally well-tolerated. However, discussing personal risks and benefits with healthcare providers remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how rhythmic auditory cues can improve gait in people with Parkinson's disease. Unlike standard treatments like medications that primarily target symptoms like tremors and stiffness, this approach uses a metronome to synchronize walking patterns. The trial compares different methods: one uses targeted rhythmic auditory cueing (TRAC) to match walking pace, while the other distorts it (dTRAC) to potentially enhance motor learning. These methods could offer non-drug options to help improve mobility and quality of life for those with Parkinson's.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

Research shows that rhythmic sounds, such as the dTRAC and TRAC methods, can help people with Parkinson's disease walk better. In this trial, participants will join different treatment arms to evaluate these methods. Studies have found that these methods can increase walking speed and step length. For instance, one study found that listening to these sounds improved both the speed and distance participants could walk. Another study showed that all participants walked faster, with speed increases ranging from 0.18 to 0.27 meters per second. These results suggest that using a metronome during walking practice can enhance walking for those with Parkinson's. ^{1 2 3 6 7}

Who Is on the Research Team?

Mike Lewek, PT, PhD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

This trial is for people aged 50-80 with Parkinson's Disease who can walk unaided for 10 minutes and are on stable levodopa doses. They should have mild to moderate disease severity, hearing within normal range (with aids if needed), and specific walking difficulties. Excluded are those with severe heart/lung conditions, other neurological issues affecting gait, ongoing physical therapy, MRI contraindications like metal implants or claustrophobia, cognitive impairments, or past deep brain stimulation surgery.

Inclusion Criteria

My Parkinson's disease is at a moderate stage.

I have difficulty walking smoothly, including shuffling or freezing.

Movement Disorders Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS-III) item 10 ≥1 and <3

Exclusion Criteria

I have had deep brain stimulation surgery.

Contraindications to MRI (e.g., metal implants, claustrophobia, etc)

Cognitive deficits (Montreal Cognitive Assessment [MoCA] < 26)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 training sessions using metronomes to influence gait, with MRI scans before and after training

4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of gait and balance

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• dTRAC
• Gait training without rhythmic auditory cues
• TRAC

Trial Overview The study tests whether using a metronome during treadmill and overground walking helps improve gait in Parkinson's patients. It involves slow rhythms on the treadmill to encourage larger steps and fast rhythms overground for quicker steps. Participants will undergo this training across 12 sessions lasting about an hour each, including pre-and post-training walking tests and brain scans (MRI).

How Is the Trial Designed?

Group I: Targeted Rhythmic Auditory Cueing (TRAC) Experimental Treatment 1 Intervention

Participants will perform walking practice on a treadmill (with a metronome set to 85% of typical cadence) and overground (with a metronome set to 115% of typical cadence).

Group II: Distorted Targeted Rhythmic Auditory Cueing (dTRAC) Experimental Treatment 1 Intervention

Participants will perform walking practice on a treadmill (with a metronome set around 85% of typical cadence) and overground (with a metronome set around 115% of typical cadence).

Group III: Control Active Control 1 Intervention

Participants will perform walking practice on a treadmill and overground without the use of a metronome.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a study involving 16 independent ambulators with Parkinson's Disease, the use of auditory stimulation from a metronome significantly improved gait performance, as measured by the Functional Ambulation Performance Score (FAP).

The results showed that auditory stimulation not only increased step length and step-extremity ratio but also decreased cycle time and double support, suggesting that it can be an effective adjunct therapy alongside traditional dopaminergic treatments for gait dysfunction in Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of pulsed auditory stimulation on various gait measurements in persons with Parkinson's Disease. Freedland, RL., Festa, C., Sealy, M., et al.[2022]

A systematic review and meta-analysis of five studies involving 188 patients with multiple sclerosis showed that rhythmic auditory cueing significantly improves gait performance, enhancing parameters like velocity, stride length, and cadence.

The findings suggest that incorporating rhythmic auditory cueing into rehabilitation programs could be beneficial for patients with multiple sclerosis, promoting better walking abilities and potentially aiding neuroplasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Rhythmic Auditory Cueing in Gait Rehabilitation for Multiple Sclerosis: A Mini Systematic Review and Meta-Analysis. Ghai, S., Ghai, I.[2023]

Auditory stimulation through rhythmic cues, like music or metronome sounds, significantly improves motor function in patients with Parkinson's disease, leading to increased walking speed and stride length.

Musically cued gait training (MCGT) not only enhances gait performance but also improves perceptual and sensorimotor timing abilities, suggesting a broader impact on timing skills in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of musically cued gait training in Parkinson's disease: beyond a motor benefit. Bella, SD., Benoit, CE., Farrugia, N., et al.[2015]

In a case series involving three individuals with stage 2 Parkinson disease, a 6-week gait training program using rhythmic auditory cueing significantly improved overground gait speed and stride length, with increases of up to 0.27 m/s in speed and 15.7 cm in stride length.

The improvements in gait speed were primarily attributed to increases in stride length rather than changes in cadence, suggesting that carefully selected auditory cues can effectively enhance walking performance in individuals with Parkinson disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Rhythmic Auditory Cueing During Treadmill and Overground Gait for Individuals With Parkinson Disease: A Case Series. Sherron, MA., Stevenson, SA., Browner, NM., et al.[2021]

Parkinson's disease patients experience motor-timing impairments, particularly in gait, but their walking can improve with rhythmic auditory cues like metronomes or music.

Adaptive rhythmic metronomes that sync with a patient's walking have been shown to enhance stability and restore healthy gait dynamics, suggesting that tailored auditory cues can significantly aid in gait rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaired movement timing in neurological disorders: rehabilitation and treatment strategies. Hove, MJ., Keller, PE.[2018]

Rhythmic auditory stimulation (RAS) using music was found to be more effective than metronomes for helping participants maintain motor timing during tasks, particularly at medium and fast tempos, suggesting that music can enhance movement coordination.

Stepping on the spot resulted in better entrainment and more stable pacing compared to finger and toe tapping, indicating that this type of movement may be particularly beneficial for individuals with Parkinson's disease in managing their gait and motor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music and Metronomes Differentially Impact Motor Timing in People with and without Parkinson's Disease: Effects of Slow, Medium, and Fast Tempi on Entrainment and Synchronization Performances in Finger Tapping, Toe Tapping, and Stepping on the Spot Tasks. Rose, D., Delevoye-Turrell, Y., Ott, L., et al.[2022]

In a 3-week home-based gait-training program for 15 Parkinson's disease patients, rhythmic auditory stimulation (RAS) significantly improved gait velocity by 25%, stride length by 12%, and step cadence by 10% compared to control groups.

The RAS group also showed notable changes in muscle activation patterns and was able to maintain improved walking speed within a 2% margin of error after training, indicating effective rhythmic entrainment of their gait patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhythmic auditory stimulation in gait training for Parkinson's disease patients. Thaut, MH., McIntosh, GC., Rice, RR., et al.[2022]

In a study involving 31 patients with Parkinson's disease and 10 healthy elderly subjects, rhythmic auditory stimulation (RAS) significantly improved gait velocity, cadence, and stride length, especially when the rhythm was set 10% faster than the participants' baseline cadence.

The findings suggest that RAS can effectively facilitate gait rehabilitation in individuals with Parkinson's disease, even in the presence of basal ganglia dysfunction, highlighting the potential for using rhythmic auditory cues in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhythmic auditory-motor facilitation of gait patterns in patients with Parkinson's disease. McIntosh, GC., Brown, SH., Rice, RR., et al.[2022]

This pilot study involving 10 participants with traumatic brain injury (TBI) explored the feasibility and potential benefits of rhythmic auditory stimulation (RAS) over a 2-week treatment period, showing improvements in gait parameters without any adverse events.

After the RAS intervention, 50% of participants improved their Functional Gait Assessment scores, indicating they were no longer at high risk of falling, highlighting the potential efficacy of RAS in enhancing mobility in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhythmic Auditory Stimulation and Gait Training in Traumatic Brain Injury: A Pilot Study. Thompson, S., Hays, K., Weintraub, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9366143/

Rhythmic auditory stimulation promotes gait recovery in ... Several systematic reviews and meta-analyses have reported the effectiveness of RAS on gait in patients with Parkinson's disease (24, 25).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32459723/

Targeted Rhythmic Auditory Cueing During Treadmill and ... Outcomes: All participants improved overground gait speed (participant 1: +0.27 m/s; participant 2: +0.20 m/s; and participant 3: +0.18 m/s) and stride length ( ...

3. nature.com nature.com/articles/s41598-025-05952-8

Influence of wearable rhythmic auditory stimulation on ... Movement therapy using Rhythmic Auditory Stimulation (RAS) has been proven beneficial in Parkinson's disease (PD).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05733819

Responders to Rhythmic Auditory Cueing in Parkinson ... The investigators hypothesize that individuals with PD will either walk farther or with more automaticity (i.e., reduced stride time variability) in the RAS ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.818559/full

Effects of Rhythmic Auditory Stimulation on Gait and Motor ... This study aimed to summarize the effectiveness of rhythmic auditory stimulation (RAS) for the treatment of gait and motor function in Parkinson's disease (PD)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12041193/

Amplifying walking activity in Parkinson's disease through ... We demonstrate the effectiveness of a real-world walking intervention delivered using an autonomous music-based digital rhythmic auditory stimulation (RAS) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07068217

Effect of Metronome-Based Structured Rhythmic Exercise ... Purpose: To assess the effects of a structured rhythmic exercise program using metronome cues on freezing episodes, gait parameters, balance, fall risk, and ...