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Behavioural Intervention

Frequent vs Intense Physical Therapy for Stroke (FEAT Trial)

N/A

Waitlist Available

Research Sponsored by Christine Holmstedt

Eligibility Criteria Checklist

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

Must have

NIHSS score of 2-18 with motor involvement

Acute stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of pt evaluation up until 90 day stroke follow up post hospital discharge

Awards & highlights

FEAT Trial Summary

This trial will research how physical therapy can help stroke patients recover better in the hospital and after.

Who is the study for?

This trial is for acute stroke patients aged 18-80 who are medically stable, can consent to treatment, and have a moderate NIHSS score with motor involvement. It excludes those with medical instability or cerebral perfusion issues requiring bed rest, inmates, dialysis patients, hemorrhagic stroke sufferers, individuals post-carotid artery stenting procedure, pregnant women or current COVID-19 positive cases.Check my eligibility

What is being tested?

The study compares the effects of frequent versus intense physical therapy (PT) sessions in the immediate aftermath of an ischemic stroke. The aim is to determine which approach better optimizes hospital stay duration and enhances long-term recovery outcomes.See study design

What are the potential side effects?

While specific side effects are not listed for PT interventions in this context, potential risks may include fatigue from increased activity levels and discomfort during exercises.

FEAT Trial Eligibility Criteria

Inclusion Criteria

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

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My stroke severity score is between 2 and 18, affecting my movement.

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I have recently had a stroke.

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I am mentally capable of understanding and agreeing to the study's procedures.

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I am between 18 and 80 years old.

FEAT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of pt evaluation up until 90 day stroke follow up post hospital discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of pt evaluation up until 90 day stroke follow up post hospital discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of pt evaluation up until 90 day stroke follow up post hospital discharge 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 Activity measure for post acute care (AM-PAC)

Change in Postural Assessment Stroke Scale (PASS)

Secondary outcome measures

Change in Modified Rankin Scale (mRS)

Change in National Institute of Health Stroke Scale Score (NIHSS)

Length of Stay

FEAT Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Frequent PT servicesExperimental Treatment1 Intervention

This group will receive physical therapy services twice a day Monday through Friday and daily Saturday and Sunday. Most sessions are geared toward bed mobility, transfers and gait training with therapeutic exercises provided to target any muscle weakness identified.

Group II: Frequent Intense PTExperimental Treatment2 Interventions

This group will receive therapy services twice per day Monday through Friday and daily Saturday and Sunday, with implementation of error augmentation training each session. This includes standard of care PT with the addition of error augmentation principles (making hard tasks harder and increasing difficulty of tasks with added resistance to already weakened muscles) to address at least 2 stroke deficits or limitations.

Group III: Error Augmentation TrainingExperimental Treatment1 Intervention

Will receive error augmentation training 3-5x/wk while inpatient Standard of care PT with the addition of error augmentation principles (making hard tasks harder and increasing difficulty of tasks with added resistance to already weakened muscles) to address at least 2 stroke deficits or limitations.

Group IV: Standard of Care PTActive Control1 Intervention

Standard of care PT services to included 3 to 5 therapy sessions per week, each session averaging between 20 to 50 minutes, delivered throughout the hospitalization. No specific instructions will be given to therapists providing standard of care PT, except that they cannot implement error augmentation training. Generally, standard of care PT during the initial hospitalization following acute stroke is provided with targeted patient-specific goals and typically primarily focuses on mobility and gait training. Most sessions are geared toward bed mobility, transfers and gait training with therapeutic exercises provided to target any muscle weakness identified.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Christine HolmstedtLead Sponsor

Frequently Asked Questions

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

Are senior citizens accepted into this clinical trial?

"The requirements for this trial state that the lower age limit of enrollment is 18 years old and the upper limit is 80."

Answered by AI

What criteria must a participant meet in order to qualify for this research?

"Potential participants in this study must have experienced a stroke, and they should be between 18 to 80 years old. Currently there are vacancies for 168 patients."

Answered by AI

Is this research endeavor currently recruiting participants?

"The clinicaltrials.gov database indicates that this trial, which was initially posted on October 20th 2023 and most recently edited September 14th, is not presently seeking participants. Nonetheless there are 1190 other trials recruiting patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Frequency vs Error Augmentation Training in Acute Physical Therapy Post Stroke

Christine Holmstedt 2024. "Frequency vs Error Augmentation Training in Acute Physical Therapy Post Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042179.