Effect of aerobic exercise prior to modified constraint-induced movement therapy outcomes in individuals with chronic hemiparesis: a study protocol for a randomized clinical trial

BACKGROUND: Recovery of upper limb function in individuals after a stroke remains challenging. Modified constraint-induced movement therapy (m-CIMT) has strong evidence for increasing the use and recovery of sensorimotor function of the paretic upper limb. Recent studies have shown that priming with aerobic exercise prior to task-specific training potentiates upper limb recovery in individuals with stroke. This protocol describes a randomized clinical trial designed to determine whether priming with moderate-high intensity aerobic exercise prior to m-CIMT will improve the manual dexterity of the paretic upper limb in individuals with chronic hemiparesis. METHODS: Sixty-two individuals with chronic hemiparesis will be randomized into two groups: Aerobic exercise + m-CIMT or Stretching + m-CIMT. m-CIMT includes 1) restraint of the nonparetic upper limb for 90% of waking hours, 2) intensive task-oriented training of the paretic upper limb for 3 h/day for 10 days and 3) behavior interventions for improving treatment adherence. Aerobic exercise will be conducted on a stationary bicycle at intervals of moderate to high intensity. Participants will be evaluated at baseline, 3, 30, and 90 days postintervention by the following instruments: Motor Activity Log, Nottingham Sensory Assessment, Wolf Motor Function Test, Box and Block Test, Nine-Hole Peg Test, Stroke Specific Quality of Life Scale and three-dimensional kinematics. The data will be tested for normality and homogeneity. Parametric data will be analyzed by two-way ANOVA with repeated measures and Bonferroni’s adjustment. For nonparametric data, the Friedman test followed by the Wilcoxon test with Bonferroni’s adjustment will be used to compare the ratings for each group. To compare the groups in each assessment, the Mann-Whitney test will be used. DISCUSSION: This study will provide valuable information about the effect of motor priming for fine upper limb skill improvement in people with chronic poststroke hemiparesis, bringing new evidence about the association of two therapies commonly used in clinical practice. TRIAL REGISTRATION: This trial was retrospectively registered (registration number RBR-83pwm3) on 07 May 2018.