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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00125658
First received: July 28, 2005
Last updated: February 13, 2013
Last verified: February 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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: February 2008
Study Completion Date: September 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Investigators
Principal Investigator: Carolynn Patten, PhD North Florida/South Georgia Veterans Health System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00125658     History of Changes
Other Study ID Numbers: B3964-R
Study First Received: July 28, 2005
Last Updated: February 13, 2013
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

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014