StrokeFEATNCT06042179
Frequency vs Error Augmentation Training in Acute Physical Therapy Post Stroke
A study testing Frequent PT and Intense PT in people with Stroke and Stroke, Acute, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Stroke, Acute, Stroke, Ischemic
- What is being tested?
- Frequent PT and Intense PT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 4 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Impact of Intense Physical Therapy on Functional Mobility Outcomes in the Acute Stroke Population - Phase II
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.
Read the 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; the study compares outcomes across four groups- 1) standard of care 2) increased frequency 3) increased intensity 4) combined increased frequency and intensity.
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
- Being tested
- Frequent PT, Intense PT
- Keywords
- Physical therapy, error augmentation training
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequent PTBehavioural
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 PTBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Frequent PT; Behavioral: Intense PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The scale is a questionnaire that asks patients about their ability to perform activities of daily living (ADL's) taking into account their physical, mental, and speech performance. On admission the questionnaire focuses on their ability to perform ADL's prior to their stroke. At discharge and at 90 day follow up the questionnaire focuses on their ability to perform ADL's at that time point. It is scored from 0 to 5. Patients with a lower score have a less severe impairment, and patients with a higher score have a more severe impairment.
Measured: On date of PT evaluation
Change in National Institute of Health Stroke Scale Score (NIHSS)
The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairments related to stroke. The impairments are graded on a 3-4 point scale with scores that range from 0-42. Patients with a higher score have a more severe impairment, and patients with a lower score have a less severe impairment.
Measured: From date of PT evaluation up until 30 day stroke follow up post hospital discharge
Length of Stay
Average hospitalization (measured in days)
Measured: From day of hospital admission to day of hospital discharge, measured in days; up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start15 Jan 2024
- Primary completion31 Mar 2025
- Study completion4 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Holmstedt, Study chair, Medical University of South Caroline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042179
- Sponsor's protocol ID
- Pro00127409
- Acronym
- FEAT
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2023
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intense Physical Therapy on Functional Mobility Outcomes in the Acute Stroke Population - Phase II
- ClinicalTrials.gov ID
- NCT06042179
- Acronym / sponsor ID
- FEAT / Pro00127409
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic
- Keywords
- Physical therapy, error augmentation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 4 May 2025 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Posted 25 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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; the study compares outcomes across four groups- 1) standard of care 2) increased frequency 3) increased intensity 4) combined increased frequency and intensity.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Frequent PTThis 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. |
| Error Augmentation Training | Experimental | Behavioral: Intense PTWill 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 | Experimental | Behavioral: Frequent PT, Behavioral: Intense PTThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequent PTPhysical 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. | Behavioural | Frequent Intense PT, Frequent PT services |
| Intense PTAlso: Error Augmentation TrainingWill 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. | Behavioural | Error Augmentation Training, Frequent Intense PT |
Primary outcome
Change in Postural Assessment Stroke Scale (PASS)
Time frame: From date of PT evaluation up until 90 day stroke follow up post hospital discharge
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.
Change in Activity Measure for Post Acute Care (AM-PAC)
Time frame: From date of PT evaluation up until 90 day stroke follow up post hospital discharge
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.
3 secondary outcomes
Patient's Modified Rankin Scale (mRS) Post Acute Stroke
Time frame: On date of PT evaluation
Change in National Institute of Health Stroke Scale Score (NIHSS)
Time frame: From date of PT evaluation up until 30 day stroke follow up post hospital discharge
Length of Stay
Time frame: From day of hospital admission to day of hospital discharge, measured in days; up to 30 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Holmstedt study chair
Medical University of South Caroline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequent PT and Intense PT in people with Stroke and Stroke, Acute, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postural Assessment Stroke Scale (PASS) (time frame: From date of PT evaluation up until 90 day stroke follow up post hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.