Frequency vs Error Augmentation Training in Acute Physical Therapy Post Stroke

NCT06042179 | Completed Results DMC

• 1 other identifier: Pro00127409
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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. This study will compare outcomes (AM-PAC, PASS, length of stay and post discharge mRS) across four groups- 1) standard of care 2) increased frequency 3) increased intensity 4) combined increased frequency and intensity. The goal of this project is to determine the appropriate dosage of post stroke mobility in the acute care hospital setting.

Conditions

Stroke; Stroke, Acute; Stroke, Ischemic

Keywords

Physical therapy; error augmentation training

Outcome Measures

Primary Outcomes (2)

• Change in Postural Assessment Stroke Scale (PASS)

  The scale measures 12 items of balance in sitting, lying and standing with increasing amounts of difficulty. It consists of a 4 point scale, measured from 0 to 3 with scores that range from 0-36. Patients with a lower score have a more severe impairment, and patients with a higher score have a less severe impairment.

  From date of PT evaluation up until 90 day stroke follow up post hospital discharge

• Change in Activity Measure for Post Acute Care (AM-PAC)

  The scale measures basic mobility in the hospital setting including moving around in bed, getting out of bed, sitting and standing, moving from a bed to a chair, walking, and going up and down stairs. It consists of a 4 point scale measured from 1 to 4 with scores that range from 6 to 24. Patients with a lower score have a more severe impairment, and patients with a higher score have a less severe impairment.

  From date of PT evaluation up until 90 day stroke follow up post hospital discharge

Secondary Outcomes (3)

• Patient's Modified Rankin Scale (mRS) Post Acute Stroke

  On date of PT evaluation

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

  From date of PT evaluation up until 30 day stroke follow up post hospital discharge

• Length of Stay

  From day of hospital admission to day of hospital discharge, measured in days; up to 30 days.

Study Arms (4)

Standard of Care PT

NO 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.

Frequent PT services

EXPERIMENTAL

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.

Behavioral: Frequent PT

Error Augmentation Training

EXPERIMENTAL

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.

Behavioral: Intense PT

Frequent Intense PT

EXPERIMENTAL

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.

Behavioral: Frequent PT; Behavioral: Intense PT

Interventions

Frequent PT BEHAVIORAL

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.

Frequent Intense PT; Frequent PT services

Intense PT BEHAVIORAL

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.

Also known as: Error Augmentation Training

Error Augmentation Training; Frequent Intense PT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute stroke
• NIHSS score of 2-18 with motor involvement
• Age 18-80
• 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) Ability to provide informed consent (alert and oriented x 4 and able to follow commands)

You may not qualify if:

• Medical instability or cerebral perfusion dependence, requiring bed rest
• Pregnancy (noted in chart)
• Inmates (noted in chart or by guards present at bedside)
• Known current COVID-19 infection (PCR positive labs)
• Dialysis (noted in chart \& performed while inpatient)
• External Carotid Artery Stenting Procedure
• Hemorrhagic Stroke

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sinead Farrelly
• Organization: Medical University of South Carolina

farrelsi@musc.edu

201-310-4065

Study Officials

• Christine Holmstedt

  Medical University of South Caroline

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be designed as a randomized control trial with a 1:1:1:1 randomization. This study will utilize a permuted block design to randomly allocate a participate to a treatment group, while maintaining a balance across treatment groups.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 18, 2023
• Study Start: January 15, 2024
• Primary Completion: March 31, 2025
• Study Completion: May 4, 2025
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Locations

US (1)