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?

The purpose of this research study is to determine how training to step with a metronome on both a treadmill, as well as overground, will influence the way that people with Parkinson disease walk. Using metronomes is commonly used in clinics, but the investigators will be using a combination of slow and fast frequencies to alter the way that people walk. The use of a slower frequency metronome on the treadmill is intended to help participants take larger steps. The use of a faster frequency metronome while walking overground is intended to help participants take faster steps.This will take place over 12 training sessions. Each session will be about an hour. It will include some walking tests and pictures of the brain (using MRI) before and after training.

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.

Is Rhythmic Auditory Gait Training safe for humans?

Research on Rhythmic Auditory Stimulation (RAS) for conditions like Parkinson's disease and traumatic brain injury shows it is generally safe, with no adverse events reported in studies. ^{1 2 3 4 5}

How does the treatment dTRAC differ from other treatments for Parkinson's disease?

The treatment dTRAC, which involves rhythmic auditory cues like metronomes and music, is unique because it uses sound to help improve walking patterns in people with Parkinson's disease. This approach leverages the brain's natural ability to synchronize movement with rhythm, potentially enhancing gait stability and dynamics more effectively than treatments without auditory cues. ^{3 5 6 7 8}

What data supports the effectiveness of the treatment Rhythmic Auditory Gait Training for Parkinson's Disease?

Research shows that using rhythmic auditory cues, like metronomes or music, can improve walking speed, stride length, and overall gait stability in people with Parkinson's disease. These improvements are due to the brain's ability to synchronize movement with auditory rhythms, which helps compensate for motor timing issues. ^{1 5 7 8 9}

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.

I am taking a stable dose of levodopa.

Exclusion Criteria

I have had deep brain stimulation surgery.

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

I am currently undergoing physical therapy.

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

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Impaired movement timing in neurological disorders: rehabilitation and treatment strategies. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of pulsed auditory stimulation on various gait measurements in persons with Parkinson's Disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of musically cued gait training in Parkinson's disease: beyond a motor benefit. [2015]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Rhythmic auditory-motor facilitation of gait patterns in patients with Parkinson's disease. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Rhythmic Auditory Stimulation and Gait Training in Traumatic Brain Injury: A Pilot Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Rhythmic auditory stimulation in gait training for Parkinson's disease patients. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Targeted Rhythmic Auditory Cueing During Treadmill and Overground Gait for Individuals With Parkinson Disease: A Case Series. [2021]