Trial Outcomes & Findings for Frequency vs Error Augmentation Training in Acute Physical Therapy Post Stroke (NCT NCT06042179)
NCT ID: NCT06042179
Last Updated: 2026-03-25
Results Overview
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.
COMPLETED
NA
102 participants
From date of PT evaluation up until 90 day stroke follow up post hospital discharge
2026-03-25
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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.
|
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.
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.
|
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.
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.
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
24
|
24
|
|
Overall Study
COMPLETED
|
22
|
22
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Frequency vs Error Augmentation Training in Acute Physical Therapy Post Stroke
Baseline characteristics by cohort
| Measure |
Standard of Care PT
n=22 Participants
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
n=22 Participants
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.
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.
|
Error Augmentation Training
n=24 Participants
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.
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.
|
Frequent Intense PT
n=24 Participants
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.
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.
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.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=138 Participants
|
17 Participants
n=62 Participants
|
12 Participants
n=123 Participants
|
15 Participants
n=158 Participants
|
52 Participants
n=88 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=138 Participants
|
5 Participants
n=62 Participants
|
12 Participants
n=123 Participants
|
9 Participants
n=158 Participants
|
40 Participants
n=88 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=138 Participants
|
9 Participants
n=62 Participants
|
14 Participants
n=123 Participants
|
10 Participants
n=158 Participants
|
47 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=138 Participants
|
13 Participants
n=62 Participants
|
10 Participants
n=123 Participants
|
14 Participants
n=158 Participants
|
45 Participants
n=88 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
1 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
2 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=138 Participants
|
11 Participants
n=62 Participants
|
13 Participants
n=123 Participants
|
13 Participants
n=158 Participants
|
47 Participants
n=88 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=138 Participants
|
10 Participants
n=62 Participants
|
10 Participants
n=123 Participants
|
9 Participants
n=158 Participants
|
38 Participants
n=88 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
1 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
3 Participants
n=88 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=138 Participants
|
22 participants
n=62 Participants
|
24 participants
n=123 Participants
|
24 participants
n=158 Participants
|
92 participants
n=88 Participants
|
PRIMARY outcome
Timeframe: From date of PT evaluation up until 90 day stroke follow up post hospital dischargeThe 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.
Outcome measures
| Measure |
Standard of Care PT
n=22 Participants
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
n=22 Participants
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.
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.
|
Error Augmentation Training
n=24 Participants
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.
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.
|
Frequent Intense PT
n=24 Participants
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.
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.
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.
|
|---|---|---|---|---|
|
Change in Postural Assessment Stroke Scale (PASS)
30-Day
|
28.78 score on a scale
Standard Deviation 10.79
|
31.38 score on a scale
Standard Deviation 5.45
|
31.75 score on a scale
Standard Deviation 6.99
|
33.68 score on a scale
Standard Deviation 5.71
|
|
Change in Postural Assessment Stroke Scale (PASS)
Initial Eval
|
19.64 score on a scale
Standard Deviation 8.68
|
19.86 score on a scale
Standard Deviation 7
|
19.25 score on a scale
Standard Deviation 8.86
|
23.21 score on a scale
Standard Deviation 7.32
|
|
Change in Postural Assessment Stroke Scale (PASS)
Day 3
|
22.95 score on a scale
Standard Deviation 9.83
|
27 score on a scale
Standard Deviation 6.26
|
23.90 score on a scale
Standard Deviation 8.83
|
29.10 score on a scale
Standard Deviation 7
|
|
Change in Postural Assessment Stroke Scale (PASS)
Discharge
|
25.86 score on a scale
Standard Deviation 8.68
|
28.95 score on a scale
Standard Deviation 5.52
|
27.74 score on a scale
Standard Deviation 7.72
|
32.17 score on a scale
Standard Deviation 5.08
|
PRIMARY outcome
Timeframe: From date of PT evaluation up until 90 day stroke follow up post hospital dischargeThe 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.
Outcome measures
| Measure |
Standard of Care PT
n=22 Participants
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
n=22 Participants
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.
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.
|
Error Augmentation Training
n=24 Participants
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.
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.
|
Frequent Intense PT
n=24 Participants
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.
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.
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.
|
|---|---|---|---|---|
|
Change in Activity Measure for Post Acute Care (AM-PAC)
Initial Eval
|
15.32 score on a scale
Standard Deviation 4.49
|
15.32 score on a scale
Standard Deviation 3.96
|
14.79 score on a scale
Standard Deviation 4.33
|
16.83 score on a scale
Standard Deviation 3.47
|
|
Change in Activity Measure for Post Acute Care (AM-PAC)
Day 3
|
17.32 score on a scale
Standard Deviation 5.10
|
19.26 score on a scale
Standard Deviation 3.68
|
17.20 score on a scale
Standard Deviation 4.94
|
19.85 score on a scale
Standard Deviation 3.83
|
|
Change in Activity Measure for Post Acute Care (AM-PAC)
Discharge
|
18.95 score on a scale
Standard Deviation 4.98
|
20.32 score on a scale
Standard Deviation 3.37
|
19.25 score on a scale
Standard Deviation 4.80
|
22.0 score on a scale
Standard Deviation 2.78
|
|
Change in Activity Measure for Post Acute Care (AM-PAC)
30-Day
|
21.41 score on a scale
Standard Deviation 4.99
|
21.75 score on a scale
Standard Deviation 3.79
|
22.81 score on a scale
Standard Deviation 2.2
|
23.0 score on a scale
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: On date of PT evaluationThe 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.
Outcome measures
| Measure |
Standard of Care PT
n=22 Participants
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
n=22 Participants
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.
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.
|
Error Augmentation Training
n=24 Participants
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.
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.
|
Frequent Intense PT
n=24 Participants
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.
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.
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.
|
|---|---|---|---|---|
|
Patient's Modified Rankin Scale (mRS) Post Acute Stroke
No symptoms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient's Modified Rankin Scale (mRS) Post Acute Stroke
No disability despite symptoms
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Patient's Modified Rankin Scale (mRS) Post Acute Stroke
Slight disability
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Patient's Modified Rankin Scale (mRS) Post Acute Stroke
Moderate Disability
|
2 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
|
Patient's Modified Rankin Scale (mRS) Post Acute Stroke
Moderate/Severe Disability
|
16 Participants
|
13 Participants
|
15 Participants
|
12 Participants
|
|
Patient's Modified Rankin Scale (mRS) Post Acute Stroke
Severe Disability
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of PT evaluation up until 30 day stroke follow up post hospital dischargeThe 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.
Outcome measures
| Measure |
Standard of Care PT
n=22 Participants
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
n=22 Participants
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.
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.
|
Error Augmentation Training
n=24 Participants
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.
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.
|
Frequent Intense PT
n=24 Participants
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.
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.
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.
|
|---|---|---|---|---|
|
Change in National Institute of Health Stroke Scale Score (NIHSS)
Initial Eval
|
8.4 score on a scale
Standard Deviation 5.15
|
7.38 score on a scale
Standard Deviation 5.18
|
7.25 score on a scale
Standard Deviation 4.11
|
7.13 score on a scale
Standard Deviation 4.39
|
|
Change in National Institute of Health Stroke Scale Score (NIHSS)
Day 3
|
6.11 score on a scale
Standard Deviation 5.57
|
5.84 score on a scale
Standard Deviation 4.14
|
5.63 score on a scale
Standard Deviation 5.11
|
4 score on a scale
Standard Deviation 3.2
|
|
Change in National Institute of Health Stroke Scale Score (NIHSS)
Discharge
|
3.95 score on a scale
Standard Deviation 3.71
|
4 score on a scale
Standard Deviation 3.49
|
4.58 score on a scale
Standard Deviation 4.38
|
2.36 score on a scale
Standard Deviation 2.5
|
|
Change in National Institute of Health Stroke Scale Score (NIHSS)
30-Day
|
3.11 score on a scale
Standard Deviation 4.44
|
2.73 score on a scale
Standard Deviation 2.63
|
2.27 score on a scale
Standard Deviation 3.58
|
1.58 score on a scale
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: From day of hospital admission to day of hospital discharge, measured in days; up to 30 days.Average hospitalization (measured in days)
Outcome measures
| Measure |
Standard of Care PT
n=22 Participants
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
n=22 Participants
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.
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.
|
Error Augmentation Training
n=24 Participants
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.
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.
|
Frequent Intense PT
n=24 Participants
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.
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.
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.
|
|---|---|---|---|---|
|
Length of Stay
|
6.20 Length of Stay
Standard Deviation 3.3
|
6.09 Length of Stay
Standard Deviation 4.97
|
6.75 Length of Stay
Standard Deviation 4.72
|
5.96 Length of Stay
Standard Deviation 3.61
|
Adverse Events
Standard of Care PT
Frequent PT Services
Error Augmentation Training
Frequent Intense PT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care PT
n=22 participants at risk
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
n=22 participants at risk
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.
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.
|
Error Augmentation Training
n=24 participants at risk
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.
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.
|
Frequent Intense PT
n=24 participants at risk
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.
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.
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.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Medical Decline/Intubation/Sedation
|
9.1%
2/22 • Number of events 2 • Hospital admission to 30 days post discharge.
|
9.1%
2/22 • Number of events 2 • Hospital admission to 30 days post discharge.
|
0.00%
0/24 • Hospital admission to 30 days post discharge.
|
8.3%
2/24 • Number of events 2 • Hospital admission to 30 days post discharge.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place