Protocol for a Randomized Controlled Trial of CI Therapy for Rehabilitation of Upper Extremity Motor Deficit: The Bringing Rehabilitation to American Veterans Everywhere Project

Abstract

Constraint-induced movement therapy (CI therapy) has been shown to reduce disability for individuals with upper extremity (UE) hemiparesis following different neurologic injuries. This article describes the study design and methodological considerations of the Bringing Rehabilitation to American Veterans Everywhere (BRAVE) Project, a randomized controlled trial of CI therapy to improve the motor deficit of participants with chronic and subacute traumatic brain injury. Our CI therapy protocol comprises 4 major components: (1) intensive training of the more-affected UE for target of 3 hour/day for 10 consecutive weekdays, (2) a behavioral technique termed shaping during training, (3) a “transfer package,” 0.5 hour/day, of behavioral techniques to transfer therapeutic gains from the treatment setting to the life situation, and (4) prolonged restraint of use of the UE not being trained. The primary endpoint is posttreatment change on the Motor Activity Log, which assesses the use of the more-affected arm outside the laboratory in everyday life situations. Data from a number of secondary outcome measures are also being collected and can be categorized as physical, genomic, biologic, fitness, cognitive/behavioral, quality of life, and neuroimaging measures.

Functional Magnetic Resonance Imaging of Language Following Constraint-Induced Aphasia Therapy Primed with Intermittent Theta Burst Stimulation in 13 Patients with Post-Stroke Aphasia

“…This indicates that while language improvements in response to CIAT primed with iTBS are possible, they may not be sustained. Additional “booster” interventions may be needed similar to the “transfer package” utilized in some of the motor recovery trials [ 49 ].…”

A Pilot Randomized Controlled Trial of Intermittent Theta Burst Stimulation as Stand-Alone Treatment for Post-Stroke Aphasia: Effects on Language and Verbal Functional Magnetic Resonance Imaging (fMRI)

“…Future neurostimulation RCTs should consider incorporating booster treatments (eg, follow-up sessions of stimulation) after some amount of time following the main intervention to test if the improvements may be maintained or regained. The idea of booster treatments has been applied to motor stroke recovery, have been shown to recoup the majority of initial improvement over a year after the initial therapy [ 35 ] and therefore show promise in maintaining beneficial effects of initial treatment [ 36 ]. Further, it seems that effects on naming ability may not be specific to iTBS since a previous RCT of language therapy alone for post-stroke aphasia also showed improved naming performance over time [ 37 ].…”

Upper Limb Motor Improvement after TBI: Systematic Review of Interventions

“…Although the wide variability in presenting symptoms and underlying severity of injuries present serious challenges in designing RCTs in individuals with TBI, 12 encouraging efforts are underway in this direction. 74 Only three studies included in this review 35,43,50 had explicit sample size calculations and one study 46 provided an estimate for numbers of participants needed for future trials. Nine of the 23 studies included participants with stroke and TBI.…”