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

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00237744
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Duration (Months): 77
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The long-range goal of this work is to identify how to target treatment so that the brain is functionally re-organized to produce movement. This study will compare treatment response to robotics versus functional neuromuscular stimulation.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Stroke; Cerebrovascular Accident; Stroke	Device: Robotics training for shoulder elbow.; Device: Surface Functional Neuromuscular Stimulation; Other: whole arm motor learning	N/A

Detailed Description

Methods. Up to ninety-six chronic stroke subjects (> 12 months post stroke) will be randomized to one of the treatment groups: Wrist/hand Functional Electrical Stimulation (FES)+whole arm motor learning group; shoulder/elbow robotics + whole arm motor learning group; and whole arm motor learning group. For all groups, treatment will offered 5 hrs/day, 5 days/week, for 12 weeks. All three treatment groups will receive motor learning therapy. For the Wrist/hand FES+whole arm motor learning group, there will be the addition of FES during treatment. For the Shoulder/elbow robotics + whole arm motor learning group there will be the addition of robotics training. Outcome measures will be collected at weeks 1, 6, 12, and three months after the end of treatment. Measures will include muscle strength (Manual Muscle Testing); coordination of joint movement (Fugl-Meyer Coordination Scale); motor control of target acquisition, pathway maintenance; and smoothness of movement (robotics measures); performance of 13 functional tasks (Arm Motor Ability Test); and quality of life (Stroke Impact Scale). Measures of brain function will be non-invasive and will include cognitive planning time, cognitive effort level, and location of brain activity during simple shoulder and arm movements. Changes in brain function measures will reflect plasticity or adaptability in response to treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: CNS Plasticity Induced By Motor Learning Technologies Following Stroke
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 training and FES of the wrist/hand.	Device: Surface Functional Neuromuscular Stimulation; training utilizing FNS to assist with movement practice; Other: whole arm motor learning; intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.
Experimental: 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.	Device: Robotics training for shoulder elbow.; training utilizing a robot to assist with movement practice; Other: whole arm motor learning; intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.
Experimental: Whole Arm Motor Learning Subjects>6 months following first stroke with diminished upper limb strength, coordination and function who received whole arm motor learning training without addition of FES or Robotics	Other: whole arm motor learning; intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.

Outcome Measures

Primary Outcome Measures

1. AMAT [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.

2. M1 Activation Absolute Change Score [at baseline and following 3 months of treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Medically stable and at least 12 months post stroke.

• Difficulty using upper limb for functional tasks.

• Age >21 years

Exclusion Criteria:

uncontrolled, chronic medical condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Cleveland	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Janis Daly, PhD MS, VA Medical Center, Cleveland

Study Documents (Full-Text)

None provided.

More Information

Publications

• Daly JJ, Hrovat K, Holcomb J, Pundik S. Brain control of functional reach in healthy adults and stroke survivors. Restor Neurol Neurosci. 2014;32(5):559-73. doi: 10.3233/RNN-130361.
• Daly JJ, Hrovat K, Pundik S, Sunshine J, Yue G. fMRI methods for proximal upper limb joint motor testing and identification of undesired mirror movement after stroke. J Neurosci Methods. 2008 Oct 30;175(1):133-42. doi: 10.1016/j.jneumeth.2008.07.025. Epub 2008 Aug 22.
• Fang Y, Daly JJ, Sun J, Hvorat K, Fredrickson E, Pundik S, Sahgal V, Yue GH. Functional corticomuscular connection during reaching is weakened following stroke. Clin Neurophysiol. 2009 May;120(5):994-1002. doi: 10.1016/j.clinph.2009.02.173. Epub 2009 Apr 10.
• Fang Y, Yue GH, Hrovat K, Sahgal V, Daly JJ. Abnormal cognitive planning and movement smoothness control for a complex shoulder/elbow motor task in stroke survivors. J Neurol Sci. 2007 May 15;256(1-2):21-9. Epub 2007 Mar 27.
• Kisiel-Sajewicz K, Fang Y, Hrovat K, Yue GH, Siemionow V, Sun CK, Jaskólska A, Jaskólski A, Sahgal V, Daly JJ. Weakening of synergist muscle coupling during reaching movement in stroke patients. Neurorehabil Neural Repair. 2011 May;25(4):359-68. doi: 10.1177/1545968310388665. Epub 2011 Feb 22.
• Wang XF, Jiang Z, Daly JJ, Yue GH. A generalized regression model for region of interest analysis of fMRI data. Neuroimage. 2012 Jan 2;59(1):502-10. doi: 10.1016/j.neuroimage.2011.07.079. Epub 2011 Jul 31.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00237744
• Other Study ID Numbers: B3709-I
• First Posted: Oct 12, 2005
• Last Update Posted: Oct 13, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by US Department of Veterans Affairs: Motor Learning; Rehabilitation; Robotics; Therapeutic Electric Stimulation
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

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

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

Baseline Characteristics

Arm/Group Title	Shoulder/Elbow Robotics + Whole Arm Motor Learning	Wrist/Hand FES + Whole Arm Motor Learning	Whole Arm Motor Learning	Total
Arm/Group Description	Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.	Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist hand >shoulder/elbow	Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow=wrist hand	Total of all reporting groups
Overall Participants	11	11	18	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	9 81.8%	9 81.8%	13 72.2%	31 77.5%
>=65 years	2 18.2%	2 18.2%	5 27.8%	9 22.5%
Sex: Female, Male (Count of Participants)
Female	3 27.3%	5 45.5%	4 22.2%	12 30%
Male	8 72.7%	6 54.5%	14 77.8%	28 70%
Region of Enrollment (participants) [Number]
United States	11 100%	11 100%	18 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	AMAT
Description	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.
Time Frame	prior to treatment and following 3 months of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

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

2. Primary Outcome

Title	M1 Activation Absolute Change Score
Description	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.
Time Frame	at baseline and following 3 months of treatment

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Wrist/Hand FES + Whole Arm Motor Learning	Shoulder/Elbow Robotics + Whole Arm Motor Learning	Whole Arm Motor Learning
Arm/Group Description	Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.	Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.	Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
Measure Participants	5	8	10
Mean (Standard Deviation) [voxels]	359.6 (323.3)	489.88 (505.8)	429.7 (327.2)

Adverse Events

Time Frame	Adverse event data were collected for the duration of study participation.
Arm/Group Title	Wrist/Hand FES + Whole Arm Motor Learning		Shoulder/Elbow Robotics + Whole Arm Motor Learning		Whole Arm Motor Learning
Arm/Group Description	Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist/hand> shoulder/elbow.)		Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.		Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow = wrist hand.
All Cause Mortality
	Wrist/Hand FES + Whole Arm Motor Learning		Shoulder/Elbow Robotics + Whole Arm Motor Learning		Whole Arm Motor Learning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Wrist/Hand FES + Whole Arm Motor Learning		Shoulder/Elbow Robotics + Whole Arm Motor Learning		Whole Arm Motor Learning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Wrist/Hand FES + Whole Arm Motor Learning		Shoulder/Elbow Robotics + Whole Arm Motor Learning		Whole Arm Motor Learning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.