Effects of trunk restraint in addition to home-based modified constraint-induced movement therapy after stroke: a randomized controlled trial

Rationale: Upper limb deficits contribute to disabilities after stroke, and constraint-induced movement therapy has been recommended to improve functional activity. People with stroke excessively move their trunk when reaching and grasping objects. Therefore, trunk restraints in addition to constraint-induced movement therapy may provide advantages over constraint-induced movement therapy alone by promoting both increases in upper limb use and movement recovery. Although a pilot study has previously evaluated this combination, the assessors were not blinded, thus compromising the validity of the results.

Aim: This study will test the hypothesis that home-based constraint-induced movement therapy plus trunk restraints are superior to constraint-induced movement therapy alone in improving strength, function, and participation with chronic stroke patients.

Design: For this prospective, blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will undertake three-hours/day of modified constraint-induced movement therapy plus trunk restraints to prevent trunk displacements, five-days/week over two-weeks, while the control group only will undertake the same doses of modified constraint-induced movement therapy. At baseline, after two-weeks of interventions, and four and 12 weeks after the cessation of the interventions, researchers blinded to group allocations will collect outcome measures. The interventions will be delivered in the individuals' homes by trained physical therapists. The constraint-induced movement therapy will include shaping, task practice, and the transfer packages.

Study outcomes: Primary outcomes will be the upper limb function (referred amounts and quality of movement). Secondary outcomes will be measured for levels of impairments (strength and dexterity), activity (reaching kinematics and observed upper limb function), and levels of participation (quality of life).