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Behavioral Intervention

Walking Interventions for Parkinson's Disease (SFYS2 Trial)

Phase 2

Recruiting

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hoehn & Yahr stages 2-3 (mild to moderate disease severity)

Evidence of walking impairment (score at least 1 on gait item of MDS_UPDRS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 weeks

Awards & highlights

SFYS2 Trial Summary

This trial will compare two walking interventions to improve movement in people with Parkinson's and measure how brain activity changes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-pharmaceutical interventions (walking to music/singing), side effects may include general fatigue from physical activity or potential strain related injuries from repetitive movement during the exercises.

SFYS2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have difficulty walking.

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I am 30 years old or older.

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I have been diagnosed with Parkinson's disease as per UK Brain Bank criteria.

SFYS2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gait speed

MRI Bold Beta Weights

SFYS2 Trial Design

2Treatment groups

Experimental Treatment

Group I: Self cueingExperimental Treatment1 Intervention

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

Group II: External cueingExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,621 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,776 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the federal government sanctioned Self cueing as a viable treatment?

"The safety of self-cueing is rated at 2, as this Phase 2 trial demonstrates the presence of data indicating general safety but lacks evidence for efficacy."

Answered by AI

Are there any openings available for prospective participants in this clinical trial?

"Affirmative. The information posted on clinicaltrials.gov states that this medical trial is now looking for participants, with first postings made available on October 5th 2023 and the last update occurring in late October of the same year. 74 patients must be recruited from a single site."

Answered by AI

What is the size of the population participating in this experiment?

"Affirmative. Clinicaltrials.gov corroborates that this research is presently recruiting, with the study having been initiated on October 5th 2023 and amended as of October 31st 2023. 74 participants are being sought from a single medical facility for enrollment in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sing For Your Saunter Part 2 R33

Gammon M Earhart 2023. "Sing For Your Saunter Part 2 R33". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06115382.