Frequent vs Intense Physical Therapy for Stroke

(FEAT Trial)

Overseen By Christine Holmstedt, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Christine Holmstedt

Disqualifiers: Medical instability, Pregnancy, Inmates, COVID-19, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 90 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best approach to physical therapy for individuals who have recently experienced a stroke. It compares frequent, shorter sessions with more intense sessions to determine which aids recovery more effectively. The focus is on patients who have had an acute stroke and are stable enough to handle increased therapy without significant changes in vital signs or mental status. Participants should exhibit noticeable motor involvement due to their stroke. The goal is to determine how therapy can best improve mobility and recovery outcomes during a hospital stay. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance stroke recovery therapies for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these physical therapy protocols are safe for stroke patients?

Research shows that physical therapy (PT) for stroke patients is both effective and safe. Studies have found that more PT sessions can lead to better recovery and lower long-term health risks. Patients who receive therapy more often usually see improvements in their ability to move.

Intense PT, which includes more challenging exercises, has also proven very helpful. Many patients gain significant strength and function. However, some studies have mixed results, especially for those who had a severe stroke.

Overall, both frequent and intense PT are generally well-tolerated by patients. No strong evidence of serious side effects from these therapies exists, indicating they are safe for most people recovering from a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing different physical therapy approaches for stroke recovery because it explores the potential benefits of "error augmentation training" and increased therapy frequency. Unlike the standard physical therapy, which focuses on mobility and gait training a few times a week, error augmentation makes tasks deliberately harder to strengthen weakened muscles by adding resistance, potentially speeding up recovery. Additionally, the trial looks at whether more frequent therapy sessions, including weekends, can lead to better outcomes by providing more consistent and intensive rehabilitation. These innovative approaches could redefine stroke rehabilitation, offering new hope for faster and more effective recovery.

What evidence suggests that this trial's physical therapy treatments could be effective for stroke recovery?

Research has shown that physical therapy can significantly aid stroke recovery. In this trial, participants will join different treatment arms to assess the effects of varying therapy intensities and frequencies. Patients receiving more frequent therapy sessions, ranging from 20 to 300 hours, often experience substantial improvements in movement skills. More therapy correlates with better long-term recovery and reduced mortality risk. Studies also indicate that more intense therapy programs can enhance movement and quality of life post-stroke. Although results for severe stroke cases vary, the overall evidence supports frequent and intense physical therapy as beneficial. ^{1 2 3 6 7}

Who Is on the Research Team?

Christine Holmstedt

Principal Investigator

Medical University of South Caroline

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have recently had a stroke.

Medical stability for increased therapy services, determined by Stroke Service NP (no large fluctuations or instability for vitals, BP, mental status or seizure like activity)

Exclusion Criteria

I have had a bleeding stroke.

You have a confirmed current COVID-19 infection based on lab tests.

I must stay in bed due to my unstable health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive physical therapy services with varying frequency and intensity, including error augmentation training, during their hospital stay

Up to 90 days

Daily sessions (in-person)

Follow-up

Participants are monitored for functional mobility outcomes and recovery post hospital discharge

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Frequent PT
• Intense PT

Trial Overview 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.

How Is the Trial Designed?

Group I: Frequent PT services Experimental Treatment 1 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 PT Experimental Treatment 2 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 Training Experimental Treatment 1 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 PT Active Control 1 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.

Who Is Running the Clinical Trial?

Christine Holmstedt

Lead Sponsor

Trials

1

Recruited

170+

Published Research Related to This Trial

Stroke survivors engage in physical activity for about 60% of their physiotherapy sessions, which includes activities like walking, sitting, and standing.

This level of physical activity may be insufficient for optimal motor recovery, suggesting that increasing practice time during therapy could enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How physically active are people with stroke in physiotherapy sessions aimed at improving motor function? A systematic review. Kaur, G., English, C., Hillier, S.[2022]

Stroke survivors often face long-term disabilities, and current rehabilitation practices do not provide enough intensity or dosage of training to promote significant recovery.

The review suggests various therapeutic strategies, such as constraint-induced movement therapy and robotics, that can enhance training intensity and dosage, potentially leading to better recovery outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting dose and intensity of training: Opportunities to enhance recovery following stroke. Donnellan-Fernandez, K., Ioakim, A., Hordacre, B.[2022]

Intensive occupational therapy (AOT) significantly improved rehabilitation outcomes for patients with acute stroke, leading to better Functional Independence Measure (FIM) and National Institutes of Health Stroke Scale (NIHSS) scores, and reduced hospitalization time.

The study, which analyzed data from 3,501 stroke patients, found that AOT was particularly beneficial for those with severe limitations in daily activities and cognitive impairments, suggesting that more intensive therapy can lead to greater improvements in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of active occupational therapy in patients with acute stroke: A propensity score-weighted retrospective study. Yamakawa, S., Nagayama, H., Tomori, K., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10216461/

A Comprehensive Review of Physical Therapy Interventions ... The study found that VR training was equally as effective as CT in improving upper extremity function during the subacute phase after a stroke.

2. obrienphysicaltherapy.net obrienphysicaltherapy.net/blog/post-stroke-rehabilitation-outcomes-statistics-on-physical-therapy-effectiveness

Post-Stroke Rehabilitation Outcomes: Statistics on Physical ... Patients receiving higher doses of rehabilitation—ranging from 20 to 300 hours—experience significant improvements in motor impairment and ...

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.046008

Association Between Frequency of Rehabilitation Therapy ... We found a positive association between rehabilitation therapy within 6 months after stroke onset and long-term mortality in patients with stroke.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39932103/

Physical rehabilitation approaches for the recovery of ... Physical rehabilitation, using a mix of different treatment components, likely improves recovery of function and mobility after stroke.

5. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.122.041098

Rehabilitation Therapy Doses Are Low After Stroke and ... Between acute stroke and 3 months, 65.0% of patients received any PT; 51.2%, any OT; and 38.3% any ST. From 3 to 6 months, 32.3% received ...

6. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.043629

A Systematic Review and Meta-Analysis | Stroke Active physiotherapy seems to increase objective physical activity in community-dwelling stroke survivors. However, the evidence is of very low certainty.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04778475

NCT04778475 | Impact of More Frequent PT Services The purpose of this study is to determine what amount of physical therapy is beneficial in the hospital setting after suffering a stroke.