Clinical trial NCT00125658: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: biomechanics
Cerebrovascular Accident
electromyography
muscular weakness
recovery of function
reflex variability stroke
upper-extremity kinematics
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-08-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Trunk Displacement
timeFrame: baseline, 10 weeks, 20 weeks
measure: Change in Shoulder Flexion
timeFrame: baseline, 10 weeks, 20 weeks
measure: Change in Elbow Extension Range of Motion
timeFrame: baseline, 10 weeks, 20 weeks
measure: Upper-extremity Fugl-Meyer Motor Assessment
timeFrame: baseline, 10 weeks, 20 weeks
Secondary outcomes:
measure: Movement Speed
timeFrame: baseline, 10 weeks, 20 weeks
measure: Movement Accuracy (Reach Path Ratio, RPR)
timeFrame: baseline, 10 weeks, 20 weeks
measure: Movement Smoothness
timeFrame: baseline, 10 weeks, 20 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: Carolynn Patten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.