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Behavioral Intervention

Isotonic Endurance Exercise for Swallowing Difficulty After Stroke

N/A

Recruiting

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

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

Must have

Able to follow 2-step commands

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of 8 weeks

Awards & highlights

Study Summary

This trial assesses effects of a novel exercise on swallowing after stroke, to improve safety and efficiency and to better understand neuroplasticity.

Who is the study for?

This trial is for adults who have had a stroke within the last 3-6 months, leading to swallowing difficulties. They must be able to take some oral intake and follow commands. It's not for those under 18 or with dysphagia due to other conditions like head injuries, cancer, surgeries affecting throat structures, or neurological diseases.Check my eligibility

What is being tested?

The study tests whether a new type of tongue exercise can help improve swallowing after a stroke. Participants will do either real exercises or sham (fake) ones as a comparison. The study also looks at brain changes using MRI scans to understand how the exercises affect recovery.See study design

What are the potential side effects?

Since this trial involves physical exercises and assessments rather than drugs, side effects may include muscle fatigue in the tongue or discomfort from doing the exercises. MRI scans are generally safe but can cause unease in tight spaces.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can understand and follow simple instructions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of 8 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

Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score)

Secondary outcome measures

Adherence

Normalized Residue Ratio Scale (NRRS)

Penetration Aspiration Scale (PAS) Scores

Other outcome measures

Change in cortical thickness

Change in fractional anisotropy (FA)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lingual Endurance ExerciseExperimental Treatment1 Intervention

The experimental exercise group will participate in 3 training sessions per day for 8 weeks. Endurance exercise will include completing isotonic endurance repetitions 3 times a day. Number of repetitions per session will be determined during baseline testing for each participant.

Group II: Sham ExercisePlacebo Group1 Intervention

The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (1-5 kPa), which will be monitored weekly via device output sent to the study team to avoid use of excessive force that would qualify as exercise (>5 kPa).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor

428 Previous Clinical Trials

634,324 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,780 Total Patients Enrolled

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

1,965 Previous Clinical Trials

2,672,727 Total Patients Enrolled

Frequently Asked Questions

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

How many people are currently participating in this research experiment?

"Indeed, clinicaltrials.gov reflects that this medical trial is actively looking for recruits, having been posted on September 1st 2023 and last updated on October 2nd 2023. As of now, the study requires 70 participants from a single site."

Answered by AI

Are enrollees still being taken for this research program?

"Clinicaltrials.gov indicates that this trial is presently recruiting participants and the information was last updated on October 2nd 2023, having first been posted a month prior on September 1st."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

K01 Impacts of Lingual Endurance Exercise

Brittany Krekeler 2023. "K01 Impacts of Lingual Endurance Exercise". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072924.

All > Dysphagia