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Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Experimental
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring biomechanics, Cerebrovascular Accident, electromyography, muscular weakness, recovery of function, reflex variability stroke, upper-extremity kinematics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Clinical diagnosis of cerebrovascular accident Single event Unilateral hemiplegia Between 6 months and 18 months post-event Impairment of upper-extremity function Ability to produce partial range of motion out of plane of gravity at shoulder, elbow, and wrist At least 10 degrees of wrist motion (any 10 degrees), and finger flexion/extension in 2 fingers Cognitive ability to follow 3-step commands Exclusion Criteria: Unstable or uncontrolled blood pressure Uncontrolled seizures Flaccid hemiplegia Severe cognitive impairment

Sites / Locations

  • North Florida/South Georgia Veterans Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

FTP: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) followed by POWER: 30 sessions (90 minute sessions, 3 times per week, 10 weeks)

POWER: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) followed by FTP: 30 sessions (90 minute sessions, 3 times per week, 10 weeks)

Outcomes

Primary Outcome Measures

Change in Trunk Displacement
Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline.
Change in Shoulder Flexion
joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.
Change in Elbow Extension Range of Motion
joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.
Upper-extremity Fugl-Meyer Motor Assessment
The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline.

Secondary Outcome Measures

Movement Speed
peak velocity of movement (cm/s) during reach-to-grasp, obtained using kinematics/motion capture. Data are change scores expressed relative to baseline.
Movement Accuracy (Reach Path Ratio, RPR)
Measure is derived from kinematics/motion analysis. RPR = ratio of actual reach trajectory relative to an idealized straight line. Data are change scores, expressed relative to baseline.
Movement Smoothness
Movement smoothness is determined by assessing the number of sub movements (i.e., starts and stops) that can be identified during performance of a task. Here the task was reach-to-grasp. Sub movement are identified from kinematics/3D motion analysis. Sub-movements represent discontinuities or "jerky" movements. For example, skilled reaching is smooth and may reveal a single movement unit; in contrast, unskilled movements will reveal multiple movement units (i.e., starts and stops). As a performer practices and learns the movement, the number of sub movements is reduced. Sub movements can also present in persons with pathology. The unit of sub movements is whole numbers, or counts, of the sub movements. Data are change scores, expressed relative to baseline.

Full Information

First Posted
July 28, 2005
Last Updated
June 21, 2017
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00125658
Brief Title
Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis
Official Title
Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.
Detailed Description
This proposal extends the work accomplished in our initial study (project #B2405R, 'Effects of Strength Training on Upper-limb Function in Post-stroke Hemiparesis'). In the present study we will conduct a double-blind, randomized clinical trial of staged rehabilitation for the upper-extremity involving sequential delivery of functional therapy and high intensity resistance training. Therefore, this proposal directly compares the effects of functional and resistance training delivered individually. The researchers' previous work investigated a hybrid therapy of functional and resistance training against functional training alone. All subjects will participate in a 5 week run-in period of no treatment. This no-treatment block will afford multiple baseline measurements and, in addition, will provide information regarding the rate and magnitude of any spontaneous recovery without treatment. Following the second baseline measurement, all subjects will be randomized to upper-extremity rehabilitation in either: Order A - 10 weeks of functional task practice training (FTP) followed by 10 weeks of high-intensity resistance training (Power) or Order B - resistance training (Power) followed by FTP. Re-evaluation will occur following each block of treatment,and retention effects will be evaluated after 6 and 12 months with no additional treatment. Subjects will be evaluated with: outcome measures used broadly in Clinical Neurology and Rehabilitation, a battery of biomechanical performance measures including: strength, muscle activation, reflex modulation, and motor coordination, and with kinematics of free reaching movements. The researchers will investigate persons in the intermediate phase of recovery which they define as between 6 and 18 months post-stroke , having completed all inpatient and outpatient therapies, with remaining residual motor deficits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
biomechanics, Cerebrovascular Accident, electromyography, muscular weakness, recovery of function, reflex variability stroke, upper-extremity kinematics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
FTP: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) followed by POWER: 30 sessions (90 minute sessions, 3 times per week, 10 weeks)
Arm Title
Experimental
Arm Type
Experimental
Arm Description
POWER: 30 sessions (90 minute sessions, 3 times per week, 10 weeks) followed by FTP: 30 sessions (90 minute sessions, 3 times per week, 10 weeks)
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Order A
Intervention Description
Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Functional Task Practice (FTP) followed by 10 weeks of Power training (dynamic resistance exercise). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program.
Intervention Type
Other
Intervention Name(s)
Experimental
Other Intervention Name(s)
Order B
Intervention Description
Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Power training (dynamic resistance exercise) followed by 10 weeks of Functional Task Practice (FTP). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program.
Primary Outcome Measure Information:
Title
Change in Trunk Displacement
Description
Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline.
Time Frame
baseline, 10 weeks, 20 weeks
Title
Change in Shoulder Flexion
Description
joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.
Time Frame
baseline, 10 weeks, 20 weeks
Title
Change in Elbow Extension Range of Motion
Description
joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.
Time Frame
baseline, 10 weeks, 20 weeks
Title
Upper-extremity Fugl-Meyer Motor Assessment
Description
The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline.
Time Frame
baseline, 10 weeks, 20 weeks
Secondary Outcome Measure Information:
Title
Movement Speed
Description
peak velocity of movement (cm/s) during reach-to-grasp, obtained using kinematics/motion capture. Data are change scores expressed relative to baseline.
Time Frame
baseline, 10 weeks, 20 weeks
Title
Movement Accuracy (Reach Path Ratio, RPR)
Description
Measure is derived from kinematics/motion analysis. RPR = ratio of actual reach trajectory relative to an idealized straight line. Data are change scores, expressed relative to baseline.
Time Frame
baseline, 10 weeks, 20 weeks
Title
Movement Smoothness
Description
Movement smoothness is determined by assessing the number of sub movements (i.e., starts and stops) that can be identified during performance of a task. Here the task was reach-to-grasp. Sub movement are identified from kinematics/3D motion analysis. Sub-movements represent discontinuities or "jerky" movements. For example, skilled reaching is smooth and may reveal a single movement unit; in contrast, unskilled movements will reveal multiple movement units (i.e., starts and stops). As a performer practices and learns the movement, the number of sub movements is reduced. Sub movements can also present in persons with pathology. The unit of sub movements is whole numbers, or counts, of the sub movements. Data are change scores, expressed relative to baseline.
Time Frame
baseline, 10 weeks, 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of cerebrovascular accident Single event Unilateral hemiplegia Between 6 months and 18 months post-event Impairment of upper-extremity function Ability to produce partial range of motion out of plane of gravity at shoulder, elbow, and wrist At least 10 degrees of wrist motion (any 10 degrees), and finger flexion/extension in 2 fingers Cognitive ability to follow 3-step commands Exclusion Criteria: Unstable or uncontrolled blood pressure Uncontrolled seizures Flaccid hemiplegia Severe cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolynn Patten, PhD
Organizational Affiliation
North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22357633
Citation
Corti M, McGuirk TE, Wu SS, Patten C. Differential effects of power training versus functional task practice on compensation and restoration of arm function after stroke. Neurorehabil Neural Repair. 2012 Sep;26(7):842-54. doi: 10.1177/1545968311433426. Epub 2012 Feb 22.
Results Reference
result
PubMed Identifier
22277759
Citation
Phadke CP, Robertson CT, Condliffe EG, Patten C. Upper-extremity H-reflex measurement post-stroke: reliability and inter-limb differences. Clin Neurophysiol. 2012 Aug;123(8):1606-15. doi: 10.1016/j.clinph.2011.12.012. Epub 2012 Jan 23.
Results Reference
result
PubMed Identifier
25135282
Citation
Phadke CP, Robertson CT, Patten C. Upper-extremity spinal reflex inhibition is reproducible and strongly related to grip force poststroke. Int J Neurosci. 2015 Jun;125(6):441-8. doi: 10.3109/00207454.2014.946990. Epub 2014 Sep 3.
Results Reference
result

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Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis

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