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: October 27, 2014
Last verified: October 2014

July 28, 2005
October 27, 2014
February 2008
June 2009   (final data collection date for primary outcome measure)
Shoulder, Arm, Hand Kinematics [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • a) Biomechanical Power (torque x velocity) in 7 upper-extremity actions
  • b) Movement smoothness during free reaching tasks
  • c) Stretch Reflex Threshold
Complete list of historical versions of study NCT00125658 on ClinicalTrials.gov Archive Site
Not Provided
  • a) EMG activation, EMG efficiency
  • b) EMG activation patterns, clinical assessments
  • c) Task-specific H-reflex modulation
Not Provided
Not Provided
 
Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis
Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Cerebrovascular Accident
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.
Arm 1
Intervention: Other: Upper Extremity Rehabilitation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00125658
B3964-R
Not Provided
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Carolynn Patten, PhD North Florida/South Georgia Veterans Health System
Department of Veterans Affairs
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP