Trial Outcomes & Findings for Impact of More Frequent PT Services (NCT NCT04778475)

Last Updated: 2023-12-18

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

From date of hospital admission up until 90 day post hospital discharge follow up

Results posted on

2023-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Group A The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay. Intensive therapy: PT services twice a day for 3-5 days and then daily for the remainder of hospital stay	Group B The control group will receive standard care of PT services 3-5 times per week during their hospitalization. Standard of care therapy: PT services 3-5 times a week for 15 to 30 minutes
Overall Study STARTED	50	50
Overall Study COMPLETED	46	50
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of More Frequent PT Services

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=46 Participants The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay. Intensive therapy: PT services twice a day for 3-5 days and then daily for the remainder of hospital stay	Group B n=50 Participants The control group will receive standard care of PT services 3-5 times per week during their hospitalization. Standard of care therapy: PT services 3-5 times a week for 15 to 30 minutes	Total n=96 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 10.9 • n=5 Participants	61.2 years STANDARD_DEVIATION 10.2 • n=7 Participants	63 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	18 Participants n=5 Participants	27 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Stroke Type Ischemic	41 Participants n=5 Participants	47 Participants n=7 Participants	88 Participants n=5 Participants
Stroke Type Hemorrhagic	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Stroke Subtype Cortical	12 Participants n=5 Participants	28 Participants n=7 Participants	40 Participants n=5 Participants
Stroke Subtype Subcortical	34 Participants n=5 Participants	22 Participants n=7 Participants	56 Participants n=5 Participants
Received tPA	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Received thrombectomy	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
NIHSS	7.6 units on a scale STANDARD_DEVIATION 4.4 • n=5 Participants	5.9 units on a scale STANDARD_DEVIATION 3.9 • n=7 Participants	6.75 units on a scale STANDARD_DEVIATION 0 • n=5 Participants
AMPAC	14.6 units on a scale STANDARD_DEVIATION 4.2 • n=5 Participants	16.6 units on a scale STANDARD_DEVIATION 4.2 • n=7 Participants	15.6 units on a scale STANDARD_DEVIATION 4.2 • n=5 Participants
mRS	3.3 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	2.9 units on a scale STANDARD_DEVIATION 1.2 • n=7 Participants	3.1 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants
PASS	20.4 units on a scale STANDARD_DEVIATION 8.9 • n=5 Participants	24.1 units on a scale STANDARD_DEVIATION 8.1 • n=7 Participants	22.25 units on a scale STANDARD_DEVIATION 8.5 • n=5 Participants

PRIMARY outcome

Timeframe: From date of hospital admission up until 90 day post hospital discharge follow up

Outcome measures

Outcome measures
Measure	Group A n=46 Participants The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay. Intensive therapy: PT services twice a day for 3-5 days and then daily for the remainder of hospital stay	Group B n=50 Participants The control group will receive standard care of PT services 3-5 times per week during their hospitalization. Standard of care therapy: PT services 3-5 times a week for 15 to 30 minutes
Change in Score of Postural Assessment Stroke Scale (PASS)	10.23 score on a scale Standard Error 0.93	5.78 score on a scale Standard Error 0.94

PRIMARY outcome

Timeframe: From date of hospital admission up until 90 days post hospital discharge follow up

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 days follow up post discharge, 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

Outcome measures
Measure	Group A n=46 Participants The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay. Intensive therapy: PT services twice a day for 3-5 days and then daily for the remainder of hospital stay	Group B n=50 Participants The control group will receive standard care of PT services 3-5 times per week during their hospitalization. Standard of care therapy: PT services 3-5 times a week for 15 to 30 minutes
Change in Modified Rankin Scale	-1.70 score on a scale Standard Error 0.19	-0.89 score on a scale Standard Error 0.19

PRIMARY outcome

Timeframe: From date of hospital admission up until 90 day post hospital discharge follow up

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.

Outcome measures

Outcome measures
Measure	Group A n=46 Participants The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay. Intensive therapy: PT services twice a day for 3-5 days and then daily for the remainder of hospital stay	Group B n=50 Participants The control group will receive standard care of PT services 3-5 times per week during their hospitalization. Standard of care therapy: PT services 3-5 times a week for 15 to 30 minutes
Change in Activity Measure for Post-Acute Care (AMPAC) Score	4.65 score on a scale Standard Error 0.44	1.90 score on a scale Standard Error 0.42

PRIMARY outcome

Timeframe: From hospital admission to hospital discharge

Average hospitalization (measured in days)

Outcome measures

Outcome measures
Measure	Group A n=46 Participants The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay. Intensive therapy: PT services twice a day for 3-5 days and then daily for the remainder of hospital stay	Group B n=50 Participants The control group will receive standard care of PT services 3-5 times per week during their hospitalization. Standard of care therapy: PT services 3-5 times a week for 15 to 30 minutes
Mean Length of Stay	5.0 Days Standard Deviation 2.8	5.3 Days Standard Deviation 3.8

SECONDARY outcome

Timeframe: From date of hospital admission up until 90 day post hospital discharge follow up

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.

Outcome measures

Outcome measures
Measure	Group A n=46 Participants The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay. Intensive therapy: PT services twice a day for 3-5 days and then daily for the remainder of hospital stay	Group B n=50 Participants The control group will receive standard care of PT services 3-5 times per week during their hospitalization. Standard of care therapy: PT services 3-5 times a week for 15 to 30 minutes
Change in National Institutes of Health Stroke Scale (NIHSS) Score	-4.79 score on a scale Standard Error 0.46	-3.45 score on a scale Standard Error 0.47

SECONDARY outcome

Timeframe: within 24 hours of hospital admission to stroke service

Outcome measures

Outcome measures
Measure	Group A n=46 Participants The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay. Intensive therapy: PT services twice a day for 3-5 days and then daily for the remainder of hospital stay	Group B n=50 Participants The control group will receive standard care of PT services 3-5 times per week during their hospitalization. Standard of care therapy: PT services 3-5 times a week for 15 to 30 minutes
Mean National Institute of Health Stroke Scale Score (NIHSS)	7.6 score on a scale Standard Deviation 4.4	5.9 score on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: Within 24 hours of hospital admission

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.

Outcome measures

Outcome measures
Measure	Group A n=46 Participants The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay. Intensive therapy: PT services twice a day for 3-5 days and then daily for the remainder of hospital stay	Group B n=50 Participants The control group will receive standard care of PT services 3-5 times per week during their hospitalization. Standard of care therapy: PT services 3-5 times a week for 15 to 30 minutes
Mean Modified Rankin Scale Score	3.3 score on a scale Standard Deviation 1.2	2.9 score on a scale Standard Deviation 1.2

Adverse Events

Group A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 3 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group A n=46 participants at risk The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay. Intensive therapy: PT services twice a day for 3-5 days and then daily for the remainder of hospital stay	Group B n=50 participants at risk The control group will receive standard care of PT services 3-5 times per week during their hospitalization. Standard of care therapy: PT services 3-5 times a week for 15 to 30 minutes
Vascular disorders Hypotension	2.2% 1/46 • Number of events 1 • Throughout study & follow up 1 year, 1 month	0.00% 0/50 • Throughout study & follow up 1 year, 1 month

Additional Information

Sinead Farrelly DPT

Medical University of South Carolina

Phone: 843-792-3069

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place