Trial Outcomes & Findings for Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke (NCT NCT02331407)

Results Overview

Arm motor control was assessed through analysis of reaching movements to targets. We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance). This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

From baseline to within 1 week post-therapy

Results posted on

2019-05-07

Participant Flow

Patients with post-stroke arm paresis were recruited from June 2009 to May 2011

Participant milestones

Participant milestones
Measure	Robot Arm Rehabilitation Therapy Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robot Arm Rehabilitation Therapy n=9 Participants Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Stroke Side Right	2 Participants n=5 Participants
Stroke Side Left	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to within 1 week post-therapy

Arm motor control was assessed through analysis of reaching movements to targets. We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance). This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control.

Outcome measures

Outcome measures
Measure	Robot Arm Rehabilitation Therapy n=9 Participants Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance	-16.31 unitless

SECONDARY outcome

Timeframe: baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy

The FM is a measure of impairment that considers movement arm, wrist, hand, and coordination. Each of the 22 items is scored on a three-point ordinal scale for total score between a minimum score of 0 and a maximum score of 66. A higher score indicates a better outcome.

Outcome measures

Outcome measures
Measure	Robot Arm Rehabilitation Therapy n=9 Participants Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
Fugl-Meyer (FM) Upper Extremity Motor Assessment Pretest 1: 3 weeks before baseline	30.3 score on a scale Standard Deviation 15.8
Fugl-Meyer (FM) Upper Extremity Motor Assessment Pretest 2: 1 week before baseline	32.8 score on a scale Standard Deviation 17.4
Fugl-Meyer (FM) Upper Extremity Motor Assessment Posttest 1: 1 week after therapy	36.0 score on a scale Standard Deviation 14.6
Fugl-Meyer (FM) Upper Extremity Motor Assessment Posttest 2: 3 weeks after therapy	38.3 score on a scale Standard Deviation 15.5

SECONDARY outcome

Timeframe: baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy

The ARAT tests hand and arm function and consists of 19 items in 4 domains: grasp, grip, pinch, and gross movement. Each domain contains items arranged into hierarchical order of difficulty such that success at the most difficult item of a specific subclass assumes success for all items lower in the hierarchy of the same class. Each item is scored on a four-point ordinal scale for total score between a minimum score of 0 and a maximum score of 57. A higher score indicates a better outcome.

Outcome measures

Outcome measures
Measure	Robot Arm Rehabilitation Therapy n=9 Participants Arm training using the ReoGo robotic device, 3 times a week for 3 weeks. Robotic arm therapy: Training with the ReoGo device
Action Research Arm Test Pretest 1: 3 weeks before baseline	19.6 score on a scale Standard Deviation 18.0
Action Research Arm Test Pretest 2: 1 week before baseline	21.3 score on a scale Standard Deviation 17.1
Action Research Arm Test Posttest 1: 1 week after therapy	23.7 score on a scale Standard Deviation 18.6
Action Research Arm Test Posttest 2: 3 weeks after therapy	25.0 score on a scale Standard Deviation 16.7

Adverse Events

Robot Arm Rehabilitation Therapy

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

Dr. Tomoko Kitago

Columbia University

Phone: 212-305-8389

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place