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Loss of arm use and strength are common problems after stroke that greatly affects independence in activities of daily living. Arm rehabilitation using robot-assisted repetitive task training has shown to improve motor recovery. However, this type of exercise cannot be done at home as these devices are large and expensive. This study will test whether a more portable, less costly, non-robotic repetitive training device called Bilateral Arm Training with Rhythmic Auditory Cuing (BATRAC) performed at home with a tele-rehabilitation format will lead to improvement in arm and hand use in patients with chronic stroke. The investigators plan to test the effectiveness of home based tele-rehabilitation with the BATRAC compared to a home and a clinic based approach.
This is a longitudinal, single blind, randomized controlled trial with three parallel 6 week intervention arms that will be conducted over a three-year time period. After obtaining informed consent, and completing baseline testing, participants will be randomized to one of three study arms: 1) Home-based BATRAC Telerehab (HBT) + TTT, 2) Lab-based BATRAC (LBB) + TTT, and 3) Delayed Entry Usual Care. This delayed entry group will serve as a control for the initial six weeks of enrollment and NOT receive an active study intervention before randomizing to one of the two active interventions. Weekly phone calls will be conducted during this control period to record general activity (household or community) and monitor amount and intensity of arm use.
Participants will complete Home-based BATRAC training or Lab-based BATRAC training three times a week for 6-9 weeks for a total of 18 training sessions. Participants will then be asked to return for a follow-up after 8 weeks of no training. A study evaluator blinded to the intervention assignment will complete all outcome measures at baseline, training completion, and at the 8 week retention follow-up. The participants in the Home-based BATRAC telerehabilitation group will be given a VA's MyHealtheVet (www.myhealth.va.gov) website account for asynchronous communication with the therapist and to access the educational features and resources about stroke, exercise and caregiver support. The interventions are as described below.
Home-based BATRAC telerehabilitation: The BATRAC training platform will be used in conjunction with the VA MyHealtheVet website. This group will have a MyHealtheVet account to access the Secure Messaging Option for VA approved electronic messaging to the study therapist. The MyHealtheVet will provide asynchronous communication with the study therapist, and will store performance information entered by the participant and caregiver related to arm exercise duration, repetitions completed and distances reached. This account can be securely linked and is VA approved for use on any home device (computer, cell phone or tablet) with internet. MyHealtheVet training will be completed at the VA and at a one-time home visit with the participant and their identified caregiver to verify access, and use.
BATRAC training will consist of 45 minutes of high intensity bilateral reaching and rest periods (see Lab-based BATRAC training details below) followed by 15 minutes of video guided Transition to Task Training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos demonstrating the exercise. The initial training will occur in the lab setting with the therapist for BATRAC instruction and TTT exercise training. The participant and caregiver will have the opportunity ask questions and develop proficiency during this training session. For the TTT, each functional task will be presented via the MyHealtheVet Secure Messaging (SM) and linked by a URL to an instructive Youtube video clip of exercise sequencing, and level of difficulty. After completion of each exercise session the participant will complete a study report form attached to the SM. This information will be available for off-line assessment of performance by the research therapist. In cases of participant non-adherence, the therapist can contact the participant via phone to review exercise barriers and motivate the individual to participate. If necessary, the therapist could change the exercise parameters and send changes within the My HealtheVet SM.
Lab-based BATRAC + TTT training: Participants randomized to this group will receive 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). The BATRAC training consists of high intensity bilateral reaching and retrieving (pushing handles away and pulling them back) on a constrained linear track to promote maximum arm extension. The track can be set at different angles in the work space. The training protocol is the same for both groups and will consist of four, 5-minute periods interspersed with 5-minute rest periods to avoid fatigue. An auditory metronome is set initially at the participant's preferred speed and for periods 1 and 3 participants move both arms simultaneously (in-phase). In periods 2 and 4 participants move both arms in alternating (antiphase) movements. A fifth bout of simultaneous arm movements will be included to reach the 45 minute training goal. Progression of the auditory cue frequency, direction of travel (pushing/pulling or in a diagonal) and distance of reach will be progressed every 2 weeks based on performance. If a progression cannot be sustained for the five-minute bouts by the end of the session, adjustments towards the previous level are made. This training will be followed by 15 minutes of transition to task training (TTT) as described below with supervision and support as needed by the therapist.
Transition to Task Training (TTT): Each participant will receive 45 minutes of their randomized BATRAC intervention followed by 15 minutes of TTT. This training is functionally based in four domains of real-world tasks: homemaking, hygiene, feeding, and dressing. Two goal directed functional tasks are selected from the four domains every two weeks and prescribed to the individual based on severity level, general interests and goal. The task design is progressive in nature and difficulty is added by changing the parameters (movement amplitude) and demand (resistance) for increased generalization to real life challenges. Assist by the therapist or caregiver is provided to prevent compensatory movements from being re-enforced. For the home-based training, the caregiver will be instructed to provide this assistance through the initial personal training as well as have access to a set of videos for each of the tasks.
Delayed Entry Usual Care: Participants randomized to this group will initially serve as a control and not receive any study interventions except for the protocol study evaluations in the same time intervals as those receiving active interventions and weekly phone calls to record general activity level. After serving as a control, this group will be entered into their delayed active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-Based BATRAC | Experimental | Home-based BATRAC training will consist of 45 minutes of high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant will be completed using the MyHealtheVet secure messaging system. |
|
| Lab-based BATRAC plus TTT | Experimental | Lab-based BATRAC will consist of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training will include high intensity bilateral reaching and rest periods followed by 15 minutes of therapist guided transition to task training (TTT). |
|
| Delayed Entry Usual Care | Placebo Comparator | Participants randomized to this group will initially serve as a control for the first 6 weeks of the study and not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They will also receive weekly phone calls to record general activity level. After serving as a control, this group will be entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-Based BATRAC plus TTT | Device | Home-based BATRAC training will consist of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT) using the BATRAC training will include high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant will be completed using the MyHealtheVet secure messaging system. |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test Performance Time (WMFT) | The change between WMFT performance time from baseline to post-training was analyzed. Change = 6week WMFT log (time) minus baseline WMFT log (time). The WMFT performance time is a measure of movement speed to complete fifteen timed tasks up to a maximum of 120 seconds. A faster time (lower value) indicates a better outcome. The WMFT logarithm transformed time (WMFT log (time)) mean values were analyzed to reduce the skewness of the WMFT time values. The primary study outcome was the between group difference in the Home-based WMFT log (time) post-training compared to the control. | Final Training (week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment Scale-Upper Extremity | The Fugl-Meyer Assessment scale is a stroke specific motor impairment measure. It provides an assessment of graded volitional arm tasks and hand movements using a scale ranging from 0-66 where a higher score indicates a better outcome. It has been shown to be valid, reliable and have high inter-rater reliability and test/retest reliability. | Final Training (week 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan S Conroy, DSc PT | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33336184 | Derived | Bhatnagar K, Bever CT, Tian J, Zhan M, Conroy SS. Comparing Home Upper Extremity Activity with Clinical Evaluations of Arm Function in Chronic Stroke. Arch Rehabil Res Clin Transl. 2020 Jun 18;2(2). doi: 10.1016/j.arrct.2020.100048. | |
| 32869689 | Derived | Conroy SS, Harcum S, Keldsen L, Bever CT Jr. Novel use of existing technology: A preliminary study of patient portal use for telerehabilitation. J Telemed Telecare. 2022 Jun;28(5):380-388. doi: 10.1177/1357633X20950172. Epub 2020 Sep 1. |
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Of 63 enrolled participants, 44 were study trial participants and 19 were participant caregivers for the home-based group. Of the 44 study trial participants, 15 did not meet inclusion criteria resulting in 29 individuals randomized into the study.
Community-dwelling adults with chronic hemiparetic arm disability were recruited from the VA Maryland Health Care System, University of Maryland Medical System, and community between May 2017 and July 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Home-based BATRAC | Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes of high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system. |
| FG001 | Lab-based BATRAC Plus TTT | Lab-based BATRAC + TTT consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT). |
| FG002 | Delayed Entry Usual Care | Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group was entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. |
| FG003 | Home-based BATRAC Caregivers | An identified caregiver provided assistance as needed for the home-based intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Caregivers did not receive outcome evaluations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Home-based BATRAC | Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of video guided transition to task training (TTT). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wolf Motor Function Test Performance Time (WMFT) | The change between WMFT performance time from baseline to post-training was analyzed. Change = 6week WMFT log (time) minus baseline WMFT log (time). The WMFT performance time is a measure of movement speed to complete fifteen timed tasks up to a maximum of 120 seconds. A faster time (lower value) indicates a better outcome. The WMFT logarithm transformed time (WMFT log (time)) mean values were analyzed to reduce the skewness of the WMFT time values. The primary study outcome was the between group difference in the Home-based WMFT log (time) post-training compared to the control. | Only 24 participants were included in the analysis, as we excluded patients who had no 6-week follow-up data on the primary outcome. | Posted | Mean | Standard Deviation | log (seconds) | Final Training (week 6) |
|
14 to 20 weeks for each subject depending on randomization 14 weeks if randomized directly to intervention (6 weeks training + 8 weeks post training follow up). 20 weeks if randomized to delayed entry control (6 weeks control + 6 weeks training + 8 weeks post training).
Adverse event reporting reflects the combined *total* number that received each intervention. Therefore, Home-Based BATRAC and Lab-Based BATRAC plus TTT listed below includes the delayed entry subject's AE's while randomized to each respective training group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home-based BATRAC | Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of video guided transition to task training (TTT). The TTT videos were linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant was completed using the MyHealtheVet secure messaging system. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall at home | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | 1 subject sustained a finger fracture, 1 subject sustained a foot fracture and 1 subject denied injury but required medication change. |
Previous VA guidance restricted MyHealtheVet (MHV) patient portal secure messaging (SM) from research making this study its first expansion as a tele-rehabilitation research tool. Several challenges related to equipment procurement and finalization of MHV patient portal research guidelines affected the recruitment timeline resulting in a small sample size. Therefore, the analysis of the primary outcome measure, a change from baseline to week 6 in Wolf performance time was underpowered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan S. Conroy | Baltimore VA Medical Center VA Maryland Health Care System | (410) 637-3213 | susan.conroy@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 4, 2019 | Nov 17, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2020 | Dec 28, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Parallel: participants are randomized to one of 3 groups: delayed control, active clinic-based training or active home-based training for the initial phase of the study. The delay group is randomly assigned to receive either clinic-based or home-based training for the second phase of the study.
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Blinded evaluator
|
| Lab-based BATRAC plus TTT | Device | Lab-based BATRAC will consist of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training will include high intensity bilateral reaching and retrieving actions (pushing handles away and pulling them back) on a constrained linear track to promote maximum arm extension. This training will be followed by 15 minutes of transition to task training (TTT) with supervision and support as needed by the therapist. |
|
| Delayed Entry Usual Care | Behavioral | Participants randomized to this group will initially serve as a control for the first 6 weeks of the study and not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions and weekly phone calls to record general activity level. |
|
| Stroke Impact Scale (SIS)-Hand Domain | The Stroke Impact Scale is self-reported structured interview consisting of eight domains examining the physical, mental, and emotional changes that occur after a stroke and contribute to a change in quality of life. The SIS has been tested and found to be reliable, valid, and sensitive to change in the stroke population. It has four physical domains which assess strength, activities of daily living (ADL), mobility, and hand function abilities post stroke. These domains can be analyzed separately and scored on a 0-100 scale where a higher score indicates a better outcome. | Final Training (week 6) |
| Withdrawal by Subject |
|
| Adverse Event |
|
| BG001 | Lab-based BATRAC Plus TTT | Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist guided transition to task training (TTT). |
| BG002 | Delayed Entry Usual Care | Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did received weekly phone calls to record general activity level. After serving as a control, this group entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. |
| BG003 | Home-based BATRAC Caregivers | An identified caregiver provided assistance as needed for the home-based intervention. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Wolf Motor Function Test Performance Time | Each of the 15 tasks were timed to a maximum of 120 seconds. The mean WMFT time was log transformed to reduce the skewness of the values and a faster time (lower value) indicates a better outcome. | Caregivers did not receive outcome evaluations. | Mean | Standard Deviation | log (seconds) |
|
| Fugl-Meyer | Scale ranging from 0-66 where a higher score indicates a better outcome. | Caregivers did not receive outcome evaluations. | Mean | Standard Deviation | units on a scale |
|
| Stroke Impact Scale-hand domain | Scored on a 0-100 scale where a higher score indicates a better outcome. | Caregivers did not receive outcome evaluations. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Lab-based BATRAC Plus TTT | Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT). |
| OG002 | Delayed Entry Usual Care | Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except for protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group was entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. |
|
|
|
| Secondary | Fugl-Meyer Assessment Scale-Upper Extremity | The Fugl-Meyer Assessment scale is a stroke specific motor impairment measure. It provides an assessment of graded volitional arm tasks and hand movements using a scale ranging from 0-66 where a higher score indicates a better outcome. It has been shown to be valid, reliable and have high inter-rater reliability and test/retest reliability. | Only 24 participants completed the 6-week post-training evaluations and were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Final Training (week 6) |
|
|
|
|
| Secondary | Stroke Impact Scale (SIS)-Hand Domain | The Stroke Impact Scale is self-reported structured interview consisting of eight domains examining the physical, mental, and emotional changes that occur after a stroke and contribute to a change in quality of life. The SIS has been tested and found to be reliable, valid, and sensitive to change in the stroke population. It has four physical domains which assess strength, activities of daily living (ADL), mobility, and hand function abilities post stroke. These domains can be analyzed separately and scored on a 0-100 scale where a higher score indicates a better outcome. | Only 24 participants completed the 6-week post-training evaluations and were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Final Training (week 6) |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | Lab-based BATRAC Plus TTT | Lab-based BATRAC consisted of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training included high intensity bilateral reaching and rest periods followed by 15 minutes of therapist supervised and guided transition to task training (TTT). | 0 | 14 | 0 | 14 | 4 | 14 |
| EG002 | Delayed Entry Usual Care | Participants randomized to this group initially served as a control for the first 6 weeks of the study and did not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They did receive weekly phone calls to record general activity level. After serving as a control, this group entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG003 | Home-based BATRAC Caregivers | An identified caregiver provided assistance as needed for the home-based intervention. | 0 | 19 | 0 | 19 | 0 | 19 |
|
| Dehydration and not taking medications | Social circumstances | Non-systematic Assessment |
|
| Cardiac Issues | Cardiac disorders | Non-systematic Assessment |
|
| Arm pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Sustained a back injury in motor vehicle accident on route to study appointment. |
|
| Chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Delayed onset muscle soreness |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
FM change was analyzed using analysis of variance followed by Dunnett's adjustment for between group comparisons in the home-based BATRAC group compared to the delayed-entry control. |
| ANOVA |
| 0.97 |
| Superiority |