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

103 Participants Needed

Trial Summary

What is the purpose of this trial?

The Department of Physical Therapy in conjunction with the Comprehensive Stroke Center at the Medical University of South Carolina (MUSC) seeks support for developing an evidence-based approach for the mobilization of patients within the first 24 hours of admission for an acute stroke and for increasing the frequency and intensity of acute PT services while inpatient. This evidence will prepare physical therapists and guide practice in the delivery of acute stroke mobilization in the hospital setting to optimize length of stay, disposition planning, and enhance long term recovery outcomes. This research hopes to challenge the clinical paradigm regarding the possibility of decreased functional outcomes with early mobilization post stroke. The investigators acknowledge that acute stroke patients may not be able to tolerate an extensive early mobility program but may benefit from shorter more frequent sessions of therapy early in their recovery. Throughout the literature, there are clinical practice guidelines for both the inpatient rehabilitation and outpatient therapy sectors and post stroke recovery. Little is known about the contribution of therapy services in the acute hospital setting and therapy's impact on long term functional gains. The goal of this project is to determine the appropriate dosage of post stroke mobility in the acute care hospital setting.

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 data supports the effectiveness of the treatment Frequent PT and Intense PT for stroke?

Research suggests that stroke patients generally benefit from physical therapy, which can improve their ability to function and potentially allow them to live at home rather than in an institution. However, the specific effectiveness of different types of physical therapy, like Frequent PT or Intense PT, is not clearly established, and more research is needed to determine the best approach. ^{1 2 3 4 5}

Is frequent or intense physical therapy safe for stroke patients?

Research suggests that more intensive physical therapy after a stroke may reduce the risk of death or deterioration and enhance recovery, indicating it is generally safe. However, the optimal intensity and timing are still being studied, and individual patient needs may vary. ^{6 7 8 9 10}

How does the Frequent vs Intense Physical Therapy treatment for stroke differ from other treatments?

This treatment is unique because it compares the effects of frequent, less intense physical therapy sessions with fewer, more intense sessions to determine which approach is more effective for stroke recovery. Unlike traditional methods, this study focuses on the frequency and intensity of therapy sessions to optimize motor recovery. ^{8 10 11 12 13}

Research Team

Christine Holmstedt

Principal Investigator

Medical University of South Caroline

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Analysis of the relationship between the utilization of physical therapy services and outcomes for patients with acute stroke. [2022]

2. Sweden pubmed.ncbi.nlm.nih.gov

Gender and being born overseas influences the amount of acute stroke therapy. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of active occupational therapy in patients with acute stroke: A propensity score-weighted retrospective study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A review of stroke rehabilitation and physiotherapy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation Therapy Doses Are Low After Stroke and Predicted by Clinical Factors. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

An early mobilization protocol successfully delivers more and earlier therapy to acute stroke patients: further results from phase II of AVERT. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Revisiting dose and intensity of training: Opportunities to enhance recovery following stroke. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

AMOBES (Active Mobility Very Early After Stroke): A Randomized Controlled Trial. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Physiotherapy after stroke: more is better? [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Intensity versus task-specificity after stroke: how important is intensity? [2016]

11. England pubmed.ncbi.nlm.nih.gov

Stroke survivors' perspectives on two novel models of inpatient rehabilitation: seven-day a week individual therapy or five-day a week circuit class therapy. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

How physically active are people with stroke in physiotherapy sessions aimed at improving motor function? A systematic review. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Comparison of an intermittent high-intensity vs continuous low-intensity physiotherapy service over 12 months in community-dwelling people with stroke: a randomized trial. [2019]