Frequency vs Error Augmentation Training in Acute Physical Therapy Post Stroke

NCT ID: NCT06042179

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2025-05-04

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. The goal of this project is to determine the appropriate dosage of post stroke mobility in the acute care hospital setting.

Detailed Description

The objective is to determine if changing one component of the overall mobility dosage, adjusting frequency or intensity, will improve patient outcomes. Phase I of this study, performed at MUSC from June 2021-June 2022, demonstrated improved functional mobility outcomes at hospital discharge for patients who received a combination of both increased frequency and intensity of PT services compared to the standard of care approach. Phase II aims to determine if these promising results can be attributed to increased frequency, increased intensity, or a combination of frequent and intense PT sessions. The proposed research will be a multidisciplinary collaborative effort from the Department of Neurology and the Department of Physical Therapy to investigate the best-practice for mobilization in the acute hospital phase of stroke. . Phase II aims to evaluate whether the dosage of increased frequency or increased intensity of Physical Therapy services led to the promising outcomes and functional improvements which the first study demonstrated.

Investigators propose to enroll 168 individuals with acute stroke admitted to MUSC and randomize them into increased frequency, increased intensity, increased frequency and intensity combined and usual care PT treatment groups. This study will be designed as a randomized control trial. Patients who agree to participate, will be assigned (at random) to either a treatment arm which will receive either more frequent therapy services, more intense therapy services (increased intensity by incorporating error augmentation training), a combination of frequent and intense therapy services (frequent bouts of error augmentation training) or to the control group (treatment as usual) which will receive the standard amount of therapy services currently provided in the hospital setting (~3-5 times per week). By studying the balance, walking and success of patients in the treatment groups compared with the standard of care group, the investigators hope to better understand the contribution of intense PT services, frequency PT services, or a combination of intense and frequent PT services on a patient's independence post stroke. Investigators know from phase I of this study that patients provided with a combination of increased frequency and intensity of PT services demonstrated significant functional improvements (measured by PASS and AMPAC) at time of hospital discharge and a decreased length of hospital stay when compared to the standard of care PT group. Phase II will help investigators to determine if these promising results can be best attributed to the intensity and error augmentation training portion of PT services, to the frequency of PT services, or to a combination of both frequent and intense PT services post stroke in the acute hospital setting.

Conditions

Stroke; Stroke, Acute; Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care PT

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Frequent PT services

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 Type: EXPERIMENTAL

Frequent PT

Intervention Type: 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.

Error Augmentation Training

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 Type: EXPERIMENTAL

Intense PT

Intervention Type: 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.

Frequent Intense PT

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 Type: EXPERIMENTAL

Frequent PT

Intervention Type: 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.

Intense PT

Intervention Type: 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.

Interventions

Frequent PT

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.

Intervention Type: BEHAVIORAL

Intense PT

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Error Augmentation Training

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christine Holmstedt

OTHER

Sponsor Role: lead

Responsible Party

Christine Holmstedt

Study Chair

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christine Holmstedt

Role: STUDY_CHAIR

Medical University of South Caroline

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00127409

Identifier Type: -

Identifier Source: org_study_id