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Rhythmic Auditory Gait Training for Parkinson's Disease

N/A

Recruiting

Led By Mike Lewek, PT, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 month follow-up

Awards & highlights

Study Summary

This trial looks to see if using metronomes at different speeds while walking can help people with Parkinson's walk better. They'll do MRI scans before/after 12 sessions of 1-hour walking.

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include fatigue from exercise; discomfort from wearing headphones or listening to metronomes; stress or anxiety related to MRI procedures; muscle soreness after training sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Six minute walk test (6MWT) at the 3 month follow up visit

Secondary outcome measures

Change in Six minute walk test (6MWT) after 4 weeks of training

Fractional anisotropy

Freezing of Gait Questionnaire score

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Targeted Rhythmic Auditory Cueing (TRAC)Experimental Treatment1 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 Treatment1 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: ControlActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,997 Total Patients Enrolled

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

1,965 Previous Clinical Trials

2,672,752 Total Patients Enrolled

Mike Lewek, PT, PhDPrincipal InvestigatorAssociate Professor

Media Library

dTRAC 2023 Treatment Timeline for Medical Study. Trial Name: NCT05864157 — N/A

Frequently Asked Questions

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

Do I qualify to participate in this experiment?

"Eligibility for this medical trial includes individuals with parkinson's disease aged between 50 and 80 years old. The research team is expecting to recruit approximately 45 patients in total."

Answered by AI

Is this research initiative open to adults of legal age?

"This research is targeting patients who have surpassed the age of 50 and are yet to reach 80 years old."

Answered by AI

Are new participants being accepted for this research endeavor?

"According to records on clinicaltrials.gov, this research is not currently open for recruitment. The trial was initially listed on the first of May 2023 and amended most recently in early August of that same year. At present, there are 511 other ongoing investigations actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease

2023. "Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05864157.