Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Other: Upper Extremity Rehabilitation
Phase III

Genetics Home Reference related topics:   Stroke  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:   Mechanisms of Upper-Extremity Motor Recovery in Post-Stroke Hemiparesis

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Shoulder, Arm, Hand Kinematics [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   40
Study Start Date:   November 2007
Estimated Study Completion Date:   November 2010
Estimated Primary Completion Date:   November 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1 Other: Upper Extremity Rehabilitation
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 activity practice and 10 weeks of 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 20 week therapy program.

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 receive either 10 weeks of functional training followed by 10 weeks of high-intensity resistance training or resistance training followed by functional training. 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-cerebrovascular accident (CVA), having completed all inpatient and outpatient therapies, with continued experience of residual motor deficits.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125658

Contacts
Contact: Jeff D Fox     (352) 376-1611 ext 5989     jeffrey.fox@va.gov    
Contact: Carolynn Patten, PhD     (352) 376-1611 ext 4160     patten@phhp.ufl.edu    

Locations
United States, Florida
North Florida/South Georgia Veterans Health System     Recruiting
      Gainesville, Florida, United States, 32608
      Contact: Jeff D Fox     352-376-1611 ext 5989     jeffrey.fox@va.gov    
      Principal Investigator: Carolynn Patten, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Carolynn Patten, PhD     North Florida/South Georgia Veterans Health System    
Contact: Jeff D Fox     (352) 376-1611 ext 5989     jeffrey.fox@va.gov    
Contact: Carolynn Patten, PhD     (352) 376-1611 ext 4160     patten@phhp.ufl.edu    
United States, Florida
North Florida/South Georgia Veterans Health System     Recruiting
      Gainesville, Florida, United States, 32608
      Contact: Jeff D Fox     352-376-1611 ext 5989     jeffrey.fox@va.gov    
      Principal Investigator: Carolynn Patten, PhD            
Department of Veterans Affairs
Principal Investigator:     Carolynn Patten, PhD     North Florida/South Georgia Veterans Health System    
  More Information

Click here for more information about this study: Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Responsible Party:   Department of Veterans Affairs ( Patten, Carolynn - Principal Investigator )
Study ID Numbers:   B3964R
First Received:   July 28, 2005
Last Updated:   June 24, 2008
ClinicalTrials.gov Identifier:   NCT00125658
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
biomechanics  
Cerebrovascular Accident  
electromyography  
muscular weakness  
recovery of function
reflex variability stroke
upper-extremity kinematics

Study placed in the following topic categories:
Paresis
Cerebral Infarction
Asthenia
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Muscle Weakness
Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Neurologic Manifestations
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

Source: National Library of Medicine (NLM) July 07, 2008