Walking Interventions for Parkinson's Disease

(SFYS2 Trial)

Not currently recruiting at 2 trial locations

Overseen By Martha Hessler

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Other neurological, Cognitive impairment, Cardiac, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how rhythm-based walking interventions can improve walking in people with Parkinson's disease. Participants will try two methods: walking to music and walking while singing, to determine which enhances walking performance and brain activity more effectively. The study spans 12 weeks, with sessions twice a week. It suits individuals diagnosed with Parkinson's disease who experience walking difficulties and are stable on their medications. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage treatment development.

Will I have to stop taking my current medications?

The trial requires that you have been stable on all Parkinson's disease medications for at least 2 months before joining, so you should not stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both music and singing exercises are well-tolerated by people with Parkinson’s disease. For training that uses music as an external guide, studies have found that walking to music safely and effectively improves walking skills. One study showed that participants with Parkinson's walked to music for 13 weeks and found it safe and manageable.

Similarly, studies suggest that training involving singing is also safe. Singing, as a rhythmic guide, has improved walking speed and stride without causing major side effects. These findings suggest that both music and singing exercises are generally safe and well-tolerated for people with Parkinson's. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for Parkinson's disease, which often involve medication to manage symptoms like tremors and stiffness, these new walking interventions focus on improving mobility through innovative cueing techniques. Researchers are excited about these methods because they use music and singing as external and self-cueing tools, respectively, to help patients with Parkinson's improve their walking ability. This approach is unique because it leverages the brain's natural response to rhythm and melody, potentially offering a non-drug option to enhance movement and quality of life for those affected by the condition.

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

Research has shown that rhythm-based walking exercises can improve walking in people with Parkinson's disease. In this trial, participants will join one of two treatment arms. The "External cueing" arm uses music to guide participants in matching their steps to the beat, resulting in smoother and faster walking. This approach enhances movement and overall quality of life for those with Parkinson's. The "Self cueing" arm involves training participants to use cues, such as singing, which also shows promise. It can stabilize walking and increase speed. Both methods use rhythm to aid in managing movement, which can be challenging for people with Parkinson's. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people over 30 with typical Parkinson's disease, stages 2-3, showing walking difficulties but stable on medication. They must be right-handed and able to walk independently for 10 minutes. Excluded are those with severe freezing of gait, significant cognitive issues, unstable health conditions, uncontrolled tremor or dyskinesia, other neurological disorders, cardiac problems affecting safety in the trial or orthopedic issues limiting walking.

Inclusion Criteria

Willing and able to provide informed consent

You are right-handed.

My Parkinson's disease is in the mild to moderate stage.

Exclusion Criteria

You have a score of 2 or more on a specific question about difficulty walking.

You are left-handed.

I have issues with my legs or back that make it hard to walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform rhythm-based walking interventions using self-cueing with singing and external cueing with music, one hour sessions twice weekly for 12 weeks

12 weeks

Follow-up

Participants are monitored for changes in brain activity and gait speed after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• External Cueing Training
• Self Cueing Training

Trial Overview

The study compares two rhythm-based walking trainings: one with music and another using singing to improve gait in Parkinson's patients. Over a period of 12 weeks, participants' walking performance and brain activity changes due to these training methods will be evaluated.

How Is the Trial Designed?

Group I: Self cueing Experimental Treatment 1 Intervention

Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.

Group II: External cueing Experimental Treatment 1 Intervention

External cueing using music, one hour sessions twice weekly for 12 weeks.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Rhythmic auditory cueing, such as using a metronome or music, can immediately improve walking speed and stride length in patients with Parkinson's disease, and long-term training can enhance these benefits.

The effectiveness of rhythmic cueing varies among patients, with those having better rhythmic abilities responding positively, while those with poor rhythmic skills may not benefit or could even experience worsened gait, highlighting the need for individualized cueing approaches using adaptive technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualization of music-based rhythmic auditory cueing in Parkinson's disease. Bella, SD., Dotov, D., Bardy, B., et al.[2019]

A systematic review of 24 studies involving 626 patients with Parkinson's disease found strong evidence that auditory rhythmical cueing can significantly improve walking speed.

However, the effectiveness of visual and tactile cueing was deemed insufficient, and there is uncertainty about whether improvements in walking speed translate to better daily activities or reduced falls in real-life situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of external rhythmical cueing on gait in patients with Parkinson's disease: a systematic review. Lim, I., van Wegen, E., de Goede, C., 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 of 35 participants with Parkinson's disease, self-generated rhythmic cues (like singing) were found to improve lower limb joint movement during gait, similar to external cues like music.

Responders to cueing techniques showed increased range of motion at the hip and ankle, suggesting that personalized cueing strategies could enhance gait speed and joint movement in individuals with varying responsiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Parkinsonian gait kinematics with self-generated and externally-generated cues: a comparison of responders and non-responders. Harrison, EC., Horin, AP., Myers, PS., et al.[2021]

In a study involving 17 patients with Parkinson's disease, rhythmic somatosensory cueing (RSC) using a vibrating device on the wrist improved walking patterns by increasing step lengths and reducing stride frequencies, regardless of walking speed.

RSC was effective even in the presence of visual distractions, indicating it could be a reliable alternative to traditional auditory cueing methods for enhancing gait in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of rhythmic somatosensory cueing on gait in patients with Parkinson's disease. van Wegen, E., de Goede, C., Lim, I., et al.[2006]

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]

This pilot study aims to assess the feasibility of using auditory rhythmic cueing (ARC) to improve mobility in stroke survivors, with 60 participants recruited over 15 months from community stroke services in North East England.

Participants will engage in 18 ARC treatment sessions over 6 weeks, and the study will evaluate recruitment, retention, and the effectiveness of ARC in enhancing gait and balance, providing valuable insights for a future larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory rhythmical cueing to improve gait and physical activity in community-dwelling stroke survivors (ACTIVATE): study protocol for a pilot randomised controlled trial. McCue, P., Del Din, S., Hunter, H., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8224645/

The Impact of Exercise Intervention with Rhythmic Auditory ...

External rhythm can help the individual affected by PD to synchronize ground contact and lift-off times when walking [34]. The cyclic characteristic of rhythmic ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1836955324000596

Research Walking training with auditory cueing improves ...

Walking training with auditory cueing is more effective than walking training alone for improving walking speed in Parkinson's disease.

3.

pmc.ncbi.nlm.nih.gov

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

Rhythmic auditory stimulation promotes gait recovery in ...

We have demonstrated that RAS improves the general motor functions (UPDRS-III), particularly in gait, mobility and quality of life, in patients with Parkinson' ...

4.

nature.com

nature.com/articles/s41531-025-00952-x

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) ...

5.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000206691

Exploring Outcome Differences of a Rhythmic Auditory ...

Rhythmic auditory stimulation (RAS)-enhanced gait training is known to improve gait and motor dysfunction in PD through external cueing but has ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003999304014832

The Effect of External Rhythmic Cues (Auditory and Visual ...

Original article. The Effect of External Rhythmic Cues (Auditory and Visual) on Walking During a Functional Task in Homes of People With Parkinson's Disease.

7.

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) ...

8.

nature.com

nature.com/articles/s41598-017-16232-5

Effect of rhythmic auditory cueing on parkinsonian gait

The analysis revealed an overall positive effect on gait velocity, stride length, and a negative effect on cadence with application of auditory cueing.