Trial Outcomes & Findings for Translating Intensive Arm Rehabilitation in Stroke to a Telerehabilitation Format (NCT NCT02665052)

Last Updated: 2021-03-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

Final Training (week 6)

Results posted on

2021-03-17

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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).	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.	Home-based BATRAC Caregivers An identified caregiver provided assistance as needed for the home-based intervention.
Overall Study STARTED	11	9	9	19
Overall Study COMPLETED	8	7	9	14
Overall Study NOT COMPLETED	3	2	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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).	Home-based BATRAC Caregivers An identified caregiver provided assistance as needed for the home-based intervention.
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	1	1	5
Overall Study Adverse Event	1	1	0

Baseline Characteristics

Caregivers did not receive outcome evaluations.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home-based BATRAC n=11 Participants 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.	Lab-based BATRAC Plus TTT n=9 Participants 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).	Delayed Entry Usual Care n=9 Participants 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.	Home-based BATRAC Caregivers n=19 Participants An identified caregiver provided assistance as needed for the home-based intervention.	Total n=48 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 8.6 • n=11 Participants	58.1 years STANDARD_DEVIATION 10.6 • n=9 Participants	58.7 years STANDARD_DEVIATION 9.4 • n=9 Participants	59.2 years STANDARD_DEVIATION 17.1 • n=19 Participants	60.1 years STANDARD_DEVIATION 11.4 • n=48 Participants
Sex: Female, Male Female	5 Participants n=11 Participants	4 Participants n=9 Participants	4 Participants n=9 Participants	11 Participants n=19 Participants	24 Participants n=48 Participants
Sex: Female, Male Male	6 Participants n=11 Participants	5 Participants n=9 Participants	5 Participants n=9 Participants	8 Participants n=19 Participants	24 Participants n=48 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=19 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Asian	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=19 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=19 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Black or African American	7 Participants n=11 Participants	8 Participants n=9 Participants	6 Participants n=9 Participants	12 Participants n=19 Participants	33 Participants n=48 Participants
Race (NIH/OMB) White	4 Participants n=11 Participants	1 Participants n=9 Participants	3 Participants n=9 Participants	7 Participants n=19 Participants	15 Participants n=48 Participants
Race (NIH/OMB) More than one race	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=19 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=19 Participants	0 Participants n=48 Participants
Region of Enrollment United States	11 Participants n=11 Participants	9 Participants n=9 Participants	9 Participants n=9 Participants	19 Participants n=19 Participants	48 Participants n=48 Participants
Wolf Motor Function Test Performance Time	3.2 log (seconds) STANDARD_DEVIATION 0.3 • n=11 Participants • Caregivers did not receive outcome evaluations.	3.3 log (seconds) STANDARD_DEVIATION 0.4 • n=9 Participants • Caregivers did not receive outcome evaluations.	3.2 log (seconds) STANDARD_DEVIATION 0.4 • n=9 Participants • Caregivers did not receive outcome evaluations.	—	3.2 log (seconds) STANDARD_DEVIATION 0.4 • n=29 Participants • Caregivers did not receive outcome evaluations.
Fugl-Meyer	32.3 units on a scale STANDARD_DEVIATION 9.5 • n=11 Participants • Caregivers did not receive outcome evaluations.	34.8 units on a scale STANDARD_DEVIATION 12.1 • n=9 Participants • Caregivers did not receive outcome evaluations.	32.2 units on a scale STANDARD_DEVIATION 9.1 • n=9 Participants • Caregivers did not receive outcome evaluations.	—	33 units on a scale STANDARD_DEVIATION 9.9 • n=29 Participants • Caregivers did not receive outcome evaluations.
Stroke Impact Scale-hand domain	28.2 units on a scale STANDARD_DEVIATION 22.9 • n=11 Participants • Caregivers did not receive outcome evaluations.	32.2 units on a scale STANDARD_DEVIATION 35.7 • n=9 Participants • Caregivers did not receive outcome evaluations.	40 units on a scale STANDARD_DEVIATION 25.6 • n=9 Participants • Caregivers did not receive outcome evaluations.	—	33.1 units on a scale STANDARD_DEVIATION 27.7 • n=29 Participants • Caregivers did not receive outcome evaluations.

PRIMARY outcome

Timeframe: Final Training (week 6)

Population: Only 24 participants were included in the analysis, as we excluded patients who had no 6-week follow-up data on the primary outcome.

Outcome measures

Outcome measures
Measure	Home-Based BATRAC n=8 Participants Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The BATRAC training included high intensity bilateral reaching and rest periods. 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.	Lab-based BATRAC Plus TTT n=7 Participants 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).	Delayed Entry Usual Care n=9 Participants 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.
Wolf Motor Function Test Performance Time (WMFT)	3.6 log (seconds) Standard Deviation 1.0	2.9 log (seconds) Standard Deviation 1.2	3.1 log (seconds) Standard Deviation 1.1

SECONDARY outcome

Timeframe: Final Training (week 6)

Population: Only 24 participants completed the 6-week post-training evaluations and were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Home-Based BATRAC n=8 Participants Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The BATRAC training included high intensity bilateral reaching and rest periods. 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.	Lab-based BATRAC Plus TTT n=7 Participants 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).	Delayed Entry Usual Care n=9 Participants 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.
Fugl-Meyer Assessment Scale-Upper Extremity	32.3 score on a scale Standard Deviation 10.6	40.7 score on a scale Standard Deviation 13.5	32.0 score on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: Final Training (week 6)

Population: Only 24 participants completed the 6-week post-training evaluations and were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Home-Based BATRAC n=8 Participants Home-based BATRAC training consisted of 60 minutes of training at home (45 minutes using the BATRAC followed by 15 minutes of video guided transition to task training (TTT)). The BATRAC training included high intensity bilateral reaching and rest periods. 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.	Lab-based BATRAC Plus TTT n=7 Participants 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).	Delayed Entry Usual Care n=9 Participants 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.
Stroke Impact Scale (SIS)-Hand Domain	31.9 score on a scale Standard Deviation 33.1	45.0 score on a scale Standard Deviation 26.5	39.4 score on a scale Standard Deviation 30.4

Adverse Events

Home-based BATRAC

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Lab-based BATRAC Plus TTT

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Delayed Entry Usual Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Home-based BATRAC Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Home-based BATRAC n=15 participants at risk 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.	Lab-based BATRAC Plus TTT n=14 participants at risk 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).	Delayed Entry Usual Care n=9 participants at risk 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.	Home-based BATRAC Caregivers n=19 participants at risk An identified caregiver provided assistance as needed for the home-based intervention.
Musculoskeletal and connective tissue disorders Fall at home	20.0% 3/15 • Number of events 3 • 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.	0.00% 0/14 • 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.	0.00% 0/9 • 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.	0.00% 0/19 • 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.
Social circumstances Dehydration and not taking medications	6.7% 1/15 • Number of events 1 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/19 • 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.
Cardiac disorders Cardiac Issues	0.00% 0/15 • 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.	0.00% 0/14 • 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.	11.1% 1/9 • Number of events 1 • 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.	0.00% 0/19 • 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.
Musculoskeletal and connective tissue disorders Arm pain	0.00% 0/15 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/19 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/19 • 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.
Musculoskeletal and connective tissue disorders Chest pain	0.00% 0/15 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/19 • 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.

Additional Information

Dr. Susan S. Conroy

Baltimore VA Medical Center VA Maryland Health Care System

Phone: (410) 637-3213

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Home-based BATRAC n=15 participants at risk 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.	Lab-based BATRAC Plus TTT n=14 participants at risk 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).	Delayed Entry Usual Care n=9 participants at risk 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.	Home-based BATRAC Caregivers n=19 participants at risk An identified caregiver provided assistance as needed for the home-based intervention.
Musculoskeletal and connective tissue disorders Fall at home	20.0% 3/15 • Number of events 3 • 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.	0.00% 0/14 • 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.	0.00% 0/9 • 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.	0.00% 0/19 • 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.
Social circumstances Dehydration and not taking medications	6.7% 1/15 • Number of events 1 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/19 • 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.
Cardiac disorders Cardiac Issues	0.00% 0/15 • 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.	0.00% 0/14 • 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.	11.1% 1/9 • Number of events 1 • 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.	0.00% 0/19 • 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.
Musculoskeletal and connective tissue disorders Arm pain	0.00% 0/15 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/19 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/19 • 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.
Musculoskeletal and connective tissue disorders Chest pain	0.00% 0/15 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/9 • 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.	0.00% 0/19 • 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.