Effect of constraint standing training on balance and gait in hemiparetic stroke patients: a single-blind randomized controlled trial protocol.

BACKGROUND

Modified Constraint-Induced Movement Therapy (mCIMT) has demonstrated significant potential in rehabilitating lower extremity motor impairments following stroke. However, mCIMT's application is often limited by the need for specialized devices to constrain the non-affected extremity and longer training duration. Constraint Standing Training (CST) is a novel variation of mCIMT that addresses these limitations by eliminating the need for constraining devices and reducing training time, thereby enhancing its feasibility for clinical implementation. Despite these advantages, the specific effects of CST on balance and gait in stroke patients remain underexplored.

METHODS

This study will use a randomized, controlled, single-blinded design. Fifty stroke patients in the chronic phase, with gait disabilities and the ability to stand independently, will be randomly assigned to either the CST group or a control group using a computer-generated randomization sequence. Exclusion criteria include physiological or cognitive impairments that may hinder evaluation or training. Both groups will undergo daily 1-h training sessions, five times per week, for 8 weeks. The CST group will undergo sequential standing training using shaping strategies from a single plane to multiple planes, while the control group will receive conventional intensive training, which includes balance and gait exercises commonly used in clinical practice. Assessments will be carried out at baseline (T0), mid-intervention (T1), post-intervention (T2), and 1 month follow-up (T3). The primary outcome of this trial is the Timed Up and Go (TUG) test. Secondary outcomes include the 10-Meter Walk Test, 6-Minute Walk Test, Berg Balance Scale, three-dimensional gait analysis, and surface electromyography. Missing data will be handled using multiple imputation by chained equations. Data will be analyzed using two-way repeated measures ANOVA or generalized estimating equations to determine differences and identify clinically relevant changes.

DISCUSSION: This protocol provides detailed CST methods to guide future research and clinical application. The study employs a randomized controlled trial design to robustly evaluate CST's effects on balance and gait in hemiparetic stroke patients. CST's sequential, multi-plane exercises offer a potentially practical alternative. However, larger, multi-center trials are recommended for future validation.

TRIAL REGISTRATION: This trial is registered at www.chictr.org.cn .

REGISTRATION NUMBER: ChiCTR2400086282. Date of registration: 27 June 2024.