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

NCT ID: NCT00237744

Last Updated: 2014-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2011-09-30

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.

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.

Conditions

Cerebral Stroke; Cerebrovascular Accident; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Surface Functional Neuromuscular Stimulation

Intervention Type: DEVICE

training utilizing FNS to assist with movement practice

whole arm motor learning

Intervention Type: OTHER

intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.

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.

Group Type: EXPERIMENTAL

Robotics training for shoulder elbow.

Intervention Type: DEVICE

training utilizing a robot to assist with movement practice

whole arm motor learning

Intervention Type: OTHER

intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.

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

Group Type: EXPERIMENTAL

whole arm motor learning

Intervention Type: OTHER

intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.

Interventions

Robotics training for shoulder elbow.

training utilizing a robot to assist with movement practice

Intervention Type: DEVICE

Surface Functional Neuromuscular Stimulation

training utilizing FNS to assist with movement practice

Intervention Type: DEVICE

whole arm motor learning

intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janis Daly, PhD MS

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center-Cleveland

Locations

VA Medical Center, Cleveland

Cleveland, Ohio, United States

Countries

United States

References

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. doi: 10.1016/j.jns.2007.01.078. Epub 2007 Mar 27.

Reference Type: BACKGROUND

PMID: 17391704 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19362515 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24613940 (View on PubMed)

Kisiel-Sajewicz K, Fang Y, Hrovat K, Yue GH, Siemionow V, Sun CK, Jaskolska A, Jaskolski 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.

Reference Type: BACKGROUND

PMID: 21343527 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21839177 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18786565 (View on PubMed)

Philips GR, Daly JJ, Principe JC. Topographical measures of functional connectivity as biomarkers for post-stroke motor recovery. J Neuroeng Rehabil. 2017 Jul 6;14(1):67. doi: 10.1186/s12984-017-0277-3.

Reference Type: DERIVED

PMID: 28683745 (View on PubMed)

Other Identifiers

B3709-I

Identifier Type: -

Identifier Source: org_study_id