Trial Outcomes & Findings for Evaluation of Early Standardized Task-Specific Training (ESTT) (NCT NCT01774110)

NCT ID: NCT01774110

Last Updated: 2015-10-01

Results Overview

Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.
• Results posted on: 2015-10-01

Participant Flow

Participant milestones

Measure	Early Standardized Task Training Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke. Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.
Overall Study STARTED	12
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Early Standardized Task Training Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke. Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.
Overall Study Lost to Follow-up	7

Baseline Characteristics

Evaluation of Early Standardized Task-Specific Training (ESTT)

Baseline characteristics by cohort

Measure	Early Standardized Task Training n=5 Participants Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke. Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants

PRIMARY outcome

Timeframe: This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.

Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.

Outcome measures

Measure	ESTT n=5 Participants
Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment	35.83 cm/sec Standard Deviation 29.36

SECONDARY outcome

Timeframe: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment

The Stroke Rehabilitation Assessment of Movement (STREAM) is a test of motor recovery after stroke. There are 3 subsections of the test, an upper extremity section, a lower extremity section and a mobility section. Each section is scored independently and is normed to 100 points. Each of the 3 sections is then combined into a total overall function score which is also normed to 100. Therefore, a score of 100 represents full recovery whereas a score of 50 represents about 50% recovery from the stroke.

Outcome measures

Measure	ESTT n=5 Participants
Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.	28.63 scores on a scale Standard Deviation 13.78

OTHER_PRE_SPECIFIED outcome

Timeframe: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment

The 6-Minute Walk Test is a test of walking endurance and walking velocity.

Outcome measures

Measure	ESTT n=5 Participants
Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment	448.66 feet Standard Deviation 215.77

Adverse Events

ESTT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen McCain, PT, DPT, NCS, Principal Investigator

University of Texas Southwestern Medical Center

Phone: 214-648-1559

Email: karen.mccain@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place