Trial Outcomes & Findings for Brain and Coordination Changes Induced By Robotics and FES Treatment Following Stroke (NCT NCT00237744)

Results Overview

The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

prior to treatment and following 3 months of treatment

Results posted on

2014-10-13

Participant Flow

Subjects were recruited by word of mouth and from an advertisement flyer.

Participant milestones

Participant milestones
Measure	Wrist/Hand FES + Whole Arm Motor Learning Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.	Shoulder/Elbow Robotics + Whole Arm Motor Learning Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.	Whole Arm Motor Learning Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
Overall Study STARTED	11	11	18
Overall Study COMPLETED	8	10	18
Overall Study NOT COMPLETED	3	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Wrist/Hand FES + Whole Arm Motor Learning Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.	Shoulder/Elbow Robotics + Whole Arm Motor Learning Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.	Whole Arm Motor Learning Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
Overall Study Withdrawal by Subject	3	1	0

Baseline Characteristics

Brain and Coordination Changes Induced By Robotics and FES Treatment Following Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shoulder/Elbow Robotics + Whole Arm Motor Learning n=11 Participants Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow \> wrist hand.	Wrist/Hand FES + Whole Arm Motor Learning n=11 Participants Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist hand \>shoulder/elbow	Whole Arm Motor Learning n=18 Participants Subjects \> 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow=wrist hand	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	31 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants	28 Participants n=4 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	18 participants n=5 Participants	40 participants n=4 Participants

PRIMARY outcome

Timeframe: prior to treatment and following 3 months of treatment

The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.

Outcome measures

Outcome measures
Measure	Shoulder/Elbow Robotics+Whole Arm Motor Learning n=10 Participants Subjects\>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.	Wrist/Hand FES+Whole Arm Motor Learning n=8 Participants The intervention provided in this group included surface FES and whole are motor learning.	Whole Arm Motor Learning Group n=18 Participants Interventions included whole arm motor learning, FES and Robotics.
AMAT Pre Treatment AMAT	1693 seconds Standard Deviation 631	1693 seconds Standard Deviation 947	1556 seconds Standard Deviation 703
AMAT Post Treatment AMAT	1386 seconds Standard Deviation 572	1341 seconds Standard Deviation 900	1187 seconds Standard Deviation 703

PRIMARY outcome

Timeframe: at baseline and following 3 months of treatment

Population: This is a sub sample of subjects eligible to undergo fMRI testing. A total of 23 subjects were eligible (5 subjects in the wrist/hand FES+ whole arm motor learning group; 8 subjects in the shoulder/elbow robotics+whole arm motor learning group and 10 subjects in the Whole arm motor learning group).

A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659.

Outcome measures

Outcome measures
Measure	Shoulder/Elbow Robotics+Whole Arm Motor Learning n=5 Participants Subjects\>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.	Wrist/Hand FES+Whole Arm Motor Learning n=8 Participants The intervention provided in this group included surface FES and whole are motor learning.	Whole Arm Motor Learning Group n=10 Participants Interventions included whole arm motor learning, FES and Robotics.
M1 Activation Absolute Change Score	359.6 voxels Standard Deviation 323.3	489.88 voxels Standard Deviation 505.8	429.7 voxels Standard Deviation 327.2

Adverse Events

Wrist/Hand FES + Whole Arm Motor Learning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Shoulder/Elbow Robotics + Whole Arm Motor Learning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Whole Arm Motor Learning

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

Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center

Malcom Randall VA Medical Center, Gainesville Florida

Phone: (352) 376-1611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place