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Behavioural Intervention

Rhythmic Auditory Stimulation for Post-Stroke Gait Improvement

Phase 1
Recruiting
Led By Louis Awad, PT, DPT, PhD
Research Sponsored by Boston University Charles River Campus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The ability to walk without another individual supporting the person's body weight for at least 6 minutes. Assistive devices, such as a cane, are allowed.
65 to 80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [ras-baseline]
Awards & highlights

Study Summary

This trial will investigate how stroke & age-related neuromotor impairments affect walking with/without Rhythmic Auditory Stimulation (RAS) to improve gait quality, speed & biomechanics.

Who is the study for?
This trial is for individuals aged 65-80 who have had a stroke at least 6 months ago and can walk unassisted for six minutes, though they may use devices like a cane. They must be able to communicate clearly but cannot join if they've had severe pain, dizziness, multiple falls recently, or other serious health issues affecting walking.Check my eligibility
What is being tested?
The study tests Rhythmic Auditory Stimulation (RAS) in post-stroke rehabilitation. Participants will do two six-minute walk tests: one with regular walking and another with RAS via metronome to see if it improves their walking distance, rhythm, speed, gait quality, and reduces the energy used while walking.See study design
What are the potential side effects?
Since this intervention involves non-invasive auditory cues and physical activity typical of standard exercise regimens for older adults and those recovering from strokes, significant side effects are not anticipated beyond normal fatigue or discomfort from increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk by myself for 6 minutes, but I may use a cane.
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I am between 65 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[ras-baseline]
This trial's timeline: 3 weeks for screening, Varies for treatment, and [ras-baseline] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Six Minute Walk test distance
Stride time variability
Secondary outcome measures
Ground Reaction Forces
Metabolic Cost of Transport
cadence changes over the 6MWT
+2 more
Other outcome measures
Stroke vs. older adults: Six Minute Walk test distance in responders
Stroke vs. older adults: Stride time Variability in responders
spatial temporal relationships over the 6MWT: Cadence to Stride length
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Walking with personalized rhythmic auditory stimulationExperimental Treatment2 Interventions
Subjects will complete a 6MWT with personalized rhythmic auditory cues
Group II: Walking without personalized rhythmic auditory stimulationActive Control1 Intervention
Subjects will complete a 6MWT without any auditory cues
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Subject-specific optimized RAS
2023
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Boston University Charles River CampusLead Sponsor
113 Previous Clinical Trials
12,117 Total Patients Enrolled
2 Trials studying Stroke
36 Patients Enrolled for Stroke
Louis Awad, PT, DPT, PhDPrincipal InvestigatorBoston University
1 Previous Clinical Trials
87 Total Patients Enrolled
1 Trials studying Stroke
87 Patients Enrolled for Stroke

Frequently Asked Questions

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

Does this medical trial permit elderly persons to participate?

"This research initiative is searching for participants aged 18 and up to 80 years old."

Answered by AI

What are the requirements to join this exploration?

"Participants in this medical trial should be between 18 and 80 years old, with a history of stroke. Approximately 44 participants are required to join the study."

Answered by AI

Is enrollment for this experiment currently available to participants?

"The details posted on clinicaltrials.gov indicate that this research study is presently enrolling patients, with the initial post being made on September 18th 2023 and the most recent update occurring October 13th of 2023."

Answered by AI

Has the FDA authorized Walking with personalized rhythmic auditory stimulation?

"Due to limited information on the safety and efficacy of Walking with personalized rhythmic auditory stimulation, it was given a rating of 1 out of 3."

Answered by AI

How many participants are taking part in this research endeavor?

"Affirmative, clinicaltrials.gov's records allude to this medical experiment being in a state of recruitment. The trial was initially posted on September 18th 2023 and recently revised October 13th 2023. 44 patients are needed from one site for the study to be completed successfully."

Answered by AI

Could you explain the key goals of this research project?

"The principal objective of this trial, measured across a [RAS-Baseline] timeline, is to evaluate Stride time variability. Other measurable metrics include Ground Reaction Forces (peak and impulse (%bw)), shifts in speed over the 6MWT (m/s), and modifications in stride length throughout the process (cm)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Responders to Rhythmic Auditory Stimulation in Individuals Post-Stroke and Older Adults
Lou Awad, PT, DPT, PhD 2023. "Responders to Rhythmic Auditory Stimulation in Individuals Post-Stroke and Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085248.
~28 spots leftby Apr 2025
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