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

NCT00125658 | Completed Results

• 1 other identifier: B3964-R
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

biomechanics; Cerebrovascular Accident; electromyography; muscular weakness; recovery of function; reflex variability stroke; upper-extremity kinematics

Outcome Measures

Primary Outcomes (4)

• 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.

  baseline, 10 weeks, 20 weeks

• Change in Shoulder Flexion

  joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.

  baseline, 10 weeks, 20 weeks

• Change in Elbow Extension Range of Motion

  joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.

  baseline, 10 weeks, 20 weeks

• 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.

  baseline, 10 weeks, 20 weeks

Secondary Outcomes (3)

• Movement Speed

  baseline, 10 weeks, 20 weeks

• Movement Accuracy (Reach Path Ratio, RPR)

  baseline, 10 weeks, 20 weeks

• Movement Smoothness

  baseline, 10 weeks, 20 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

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)

Other: Control

Experimental

EXPERIMENTAL

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)

Other: Experimental

Interventions

Control OTHER

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.

Also known as: Order A

Control

Experimental OTHER

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.

Also known as: Order B

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable or uncontrolled blood pressure
• Uncontrolled seizures
• Flaccid hemiplegia
• Severe cognitive impairment

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Related Publications (3)

• 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.

  PMID: 22357633 RESULT

• 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.

  PMID: 22277759 RESULT

• 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.

  PMID: 25135282 RESULT

MeSH Terms

Conditions

Stroke; Muscle Weakness

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Limitations and Caveats

This was a small clinical trial (total n = 14).

Results Point of Contact

• Title: Dr. Carolynn Patten
• Organization: VA Brain Rehabilitation Research Center

carolynn.patten@va.gov

352.376.1611

Study Officials

• Carolynn Patten, PhD

  North Florida/South Georgia Veterans Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2005
• First Posted: August 1, 2005
• Study Start: February 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2011
• Last Updated: June 23, 2017
• Results First Posted: June 23, 2017

Record last verified: 2017-06

Locations

US (1)