Walking Interventions for Parkinson's Disease

(SFYS2 Trial)

Recruiting at 1 trial location

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

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to compare to rhythm-based walking interventions to enhance gait in people with Parkinson's disease. The main questions it aims to answer are: * How does rhythm-based training influence walking performance? * How does brain activity change following rhythm-based training? Participants will perform walking to music and walking while singing, and will train on the use of these rhythms for 12 weeks. The investigators will compare the effects of training with music to training with singing.

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 walking intervention with rhythmic cues safe for humans?

Research on rhythmic cueing for walking, such as auditory and somatosensory cues, has been conducted with Parkinson's disease patients and stroke survivors, showing it can be safely used to improve walking patterns without reported safety concerns. ^{1 2 3 4 5}

How is the treatment 'Walking Interventions for Parkinson's Disease' different from other treatments for this condition?

This treatment is unique because it uses rhythmic cues, like music or a metronome, to help people with Parkinson's disease improve their walking. It can be personalized to each person's needs, making it a flexible and potentially more effective option compared to standard treatments. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment External Cueing Training, Rhythm-Based Walking Interventions, Auditory Rhythmic Stimulation, External Cueing Therapy, Self Cueing Training, Auditory Cueing, Visual Cueing, Rhythm-Based Training, Self-Paced Walking with Rhythmic Cues for Parkinson's Disease?

Research shows that rhythmic auditory cueing, like using a metronome or music, can help people with Parkinson's disease walk better by increasing their speed and stride length. Individualized rhythmic cueing, which adapts to a person's walking pattern, can be a safe and cost-effective way to improve walking in everyday life. ^{1 2 3 4 6}

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

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]

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]

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of rhythmic somatosensory cueing on gait in patients with Parkinson's disease. [2006]

2. 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]

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

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

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

Individualization of music-based rhythmic auditory cueing in Parkinson's disease. [2019]

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

Effects of external rhythmical cueing on gait in patients with Parkinson's disease: a systematic review. [2022]

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Changes in Parkinsonian gait kinematics with self-generated and externally-generated cues: a comparison of responders and non-responders. [2021]