Trial Outcomes & Findings for Evaluation of Robot Assisted Neuro-Rehabilitation (NCT NCT01253018)

Last Updated: 2019-10-30

Results Overview

This is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

59 participants

Primary outcome timeframe

Baseline, 12 week, and 24 week retention

Results posted on

2019-10-30

Participant Flow

Recruitment occurred between April 2011 and March 2014. The study location was a clinical research setting within the Veterans Affairs Maryland Health Care System.

14 enrolled participants were withdrawn prior to randomization due to not meeting FM inclusion criteria, or due to medical or social issues.

Participant milestones

Participant milestones
Measure	Robot Therapy 12 weeks of robot-assisted upper extremity exercise using 2 different robots in a sequential 4 week progression in 3 distinct modules: wrist, shoulder-elbow and alternating sessions of wrist and shoulder-elbow robot. Sessions were 3x/week x 60 minutes.	Transition to Task Training 12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
Overall Study STARTED	22	23
Overall Study COMPLETED	18	21
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Robot Therapy 12 weeks of robot-assisted upper extremity exercise using 2 different robots in a sequential 4 week progression in 3 distinct modules: wrist, shoulder-elbow and alternating sessions of wrist and shoulder-elbow robot. Sessions were 3x/week x 60 minutes.	Transition to Task Training 12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
Overall Study Lost to Follow-up	1	1
Overall Study Robot Repair Issues	2	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Evaluation of Robot Assisted Neuro-Rehabilitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robot Therapy n=22 Participants 12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes	Transition to Task Training n=23 Participants 12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)	Total n=45 Participants Total of all reporting groups
Age, Continuous	55.7 years STANDARD_DEVIATION 10.2 • n=5 Participants	56.4 years STANDARD_DEVIATION 12.7 • n=7 Participants	56.1 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized White	7 participants n=5 Participants	14 participants n=7 Participants	21 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	14 participants n=5 Participants	8 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Asian Indian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants
Type of Stroke Ishemic	18 participants n=5 Participants	19 participants n=7 Participants	37 participants n=5 Participants
Type of Stroke Hemorrhagic	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 week, and 24 week retention

Population: All participants completing the 12 week intervention including evaluations at baseline, weeks 4, 8, 12 and at the 24 week retention evaluation. 1 participant in each group did not return for retention and were not included in the retention analysis.

Outcome measures

Outcome measures
Measure	Robot Therapy n=19 Participants 12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes	Transition to Task Training n=22 Participants 12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
Fugl-Meyer Motor Upper Extremity Assessment Change BL to 12 weeks	2.7 units on a scale Standard Deviation 3.0	3.7 units on a scale Standard Deviation 3.4
Fugl-Meyer Motor Upper Extremity Assessment Change BL to 24 weeks	3.7 units on a scale Standard Deviation 4.6	3.5 units on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: week 12

Population: The severity of the patients enrolled in the study were such that TMS did not evoke the number of motor action potentials needed for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 week, and 24 week retention

Population: All participants completing the 12 week intervention including evaluations at baseline, weeks 4, 8, 12 and at the 24 week retention evaluation. The change score from baseline to the final (12 week) evaluation was examined. 1 participant in each group did not return for retention and were not included in the retention analysis.

The Wolf Motor Function Test (WMFT) examines UE function based on task performance time, quality of movement, and ability to hold a weight. Functional use and speed of movement are based on fifteen timed activities and two strength activities. It has high inter-rater reliability, internal consistency, and test-retest reliability. Timed tasks that cannot be completed default to a time score of 120 seconds. Faster times or a lower score in seconds represent better function. Improvement is represented by a decreased time to complete the tasks therefore a negative change score from baseline to follow-up indicates improvement.

Outcome measures

Outcome measures
Measure	Robot Therapy n=19 Participants 12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes	Transition to Task Training n=22 Participants 12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
Wolf Motor Function Test (WMFT) Change BL to 12 weeks	-5.1 seconds Standard Deviation 6.2	-9.4 seconds Standard Deviation 10.3
Wolf Motor Function Test (WMFT) Change BL to 24 weeks	-7.6 seconds Standard Deviation 9.8	-8.6 seconds Standard Deviation 11.8

SECONDARY outcome

Timeframe: Baseline, 12 week and 24 week retention

Population: All participants completing the 12 week intervention including evaluations at baseline, weeks 12 and the 24 week retention evaluation. The change score from baseline to the final (12 week) evaluation was examined. 1 participant in each group did not return for retention and were not included in the retention analysis.

The Stroke Impact Scale (SIS) is a self-report structured interview consisting of eight domains designed to assess changes in impairment, disabilities, and handicap following stroke that contribute to quality of life. It has been tested and found to be reliable, valid, and sensitive to change in the stroke population. There are four physical domains that that can be analyzed separately. The hand domain was analyzed for this study and the scores for this domain range from 0-100. Higher scores indicate greater function.

Outcome measures

Outcome measures
Measure	Robot Therapy n=19 Participants 12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes	Transition to Task Training n=22 Participants 12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
Stroke Impact Scale: Hand Subscale Change BL to 12 weeks	5.8 units on a scale Standard Deviation 14.3	15.5 units on a scale Standard Deviation 20.4
Stroke Impact Scale: Hand Subscale Change BL to 24 weeks	7.8 units on a scale Standard Deviation 12.0	13.8 units on a scale Standard Deviation 16.5

Adverse Events

Robot Therapy

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Transition to Task Training

Serious events: 4 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Robot Therapy n=21 participants at risk 12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes	Transition to Task Training n=22 participants at risk 12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
Cardiac disorders Stent Placement	4.8% 1/21 • Number of events 1 • 8.5 months	0.00% 0/22 • 8.5 months
Cardiac disorders Atrial Fib	0.00% 0/21 • 8.5 months	4.5% 1/22 • Number of events 1 • 8.5 months
Nervous system disorders Seizure	9.5% 2/21 • Number of events 2 • 8.5 months	4.5% 1/22 • Number of events 1 • 8.5 months
Nervous system disorders Hospitalization to r/o new CVA	0.00% 0/21 • 8.5 months	9.1% 2/22 • Number of events 2 • 8.5 months

Other adverse events

Other adverse events
Measure	Robot Therapy n=21 participants at risk 12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes	Transition to Task Training n=22 participants at risk 12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
Musculoskeletal and connective tissue disorders Fall at home with resulting fx to study arm	0.00% 0/21 • 8.5 months	9.1% 2/22 • Number of events 2 • 8.5 months

Additional Information

Dr. Christopher T. Bever, Jr. MD, MBA

VA Maryland Health Care System

Phone: (410) 605-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place