Improvement of gait and balance function in chronic post-stroke patients induced by Lower Extremity - Constraint Induced Movement Therapy: a randomized controlled clinical trial.

OBJECTIVE: To evaluate the effects of Lower Extremity - Constraint Induced Movement Therapy on gait function and balance in chronic hemiparetic patients. METHODS: Randomized, controlled, single-blinded study. We recruited chronic post stroke patients and allocated them to Lower Extremity - Constraint Induced Movement Tharapy (LE-CIMT) or Control Group. The LE-CIMT group received this protocol 2.5 hour/day for 15 followed days, including: 1) intensive supervised training, 2) use of shaping as a strategy for motor training, and 3) application of a transfer package. The control group received conventional physiotherapy for 2.5 hours/day for 15 followed days. Outcomes were assessed at baseline, after the interventions, and after 6 months, through 6-minute walk test and Mini-Balance Evaluation Systems Test; 10-meter walk test, Timed Up and Go, 3-D gait analysis, and Lower Extremity - Motor Activity Log. RESULTS: LE-CIMT was superior on the Assistance and confidence subscale of Lower Extremity - Motor Activity Log, Mini-BESTest and 6-minute walk test. The effect size for all outcomes was small when comparing both groups. LE-CIMT showed clinically significant differences in daily activities, balance, and gait capacity, with no clinically significant difference for spatiotemporal parameters. CONCLUSION: The LE-CIMT protocol had positive outcomes on balance, performance, and confidence perception.

Effects of lower extremity constraint-induced movement therapy on gait and balance of chronic hemiparetic patients after stroke: description of a study protocol for a randomized controlled clinical trial.

BACKGROUND: Protocols involving intensive practice have shown positive outcomes. Constraint induced movement therapy (CIT) appears to be one of the best options for better outcomes in upper limb rehabilitation, but we still have little data about lower extremity constraint-induced movement therapy (LE-CIT) and its effects on gait and balance. OBJECTIVE: To evaluate the effects of an LE-CIT protocol on gait functionality and balance in chronic hemiparetic patients following a stroke. METHODS: The study adopts a randomized, controlled, single-blinded study design. Forty-two patients, who suffered a stroke, who were in the chronic phase of recovery (>6 months), with gait disability (no community gait), and who were able to walk at least 10 m with or without the advice or support of 1 person, will be randomly allocated to 2 groups: the LE-CIT group or the control group (intensive conventional therapy). People will be excluded if they have speech deficits that render them unable to understand and/or answer properly to evaluation scales and exercises selected for the protocol and/or if they have suffered any clinical event between the screening and the beginning of the protocol. Outcome will be assessed at baseline (T0), immediately after the intervention (T1), and after 6 months (T2). The outcome measures chosen for this trial are as follows: 6-min walk test (6minWT), 10-m walk test (10mWT), timed up and go (TUG), 3-D gait analysis (3DGA), Mini Balance Evaluation Systems Test (Mini-BESTest), and as a secondary measure, Lower Extremity Motor Activity Log will be evaluated (LE-MAL). The participants in both groups will receive 15 consecutive days of daily exercise. The participants in the LE-CIT group will be submitted to this protocol 2.5 h/day for 15 consecutive days. It will include (1) intensive supervised training, (2) use of shaping as strategy for motor training, and (3) application of a transfer package (plus 30 min). The control group will receive conventional physiotherapy for 2.5 h/day over 15 consecutive days (the same period as the CIT intervention). Repeated measures analyses will be made to compare differences and define clinically relevant changes between groups. RESULTS: Data collection is currently on-going and results are expected in 2021. DISCUSSION: LE-CIT seems to be a good protocol for inclusion into stroke survivors' rehabilitation as it has all the components needed for positive results, as well as intensity and transference of gains to daily life activities. TRIAL REGISTRATION: www.ensaiosclinicos.gov.br RBR-467cv6 . Registered on 10 October 2017. "Effects of Lower Extremities - Constraint Induced Therapy on gait and balance function in chronic hemipretic post-stroke patients".