Abstract
BackgroundProtocols 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.ObjectiveTo evaluate the effects of an LE-CIT protocol on gait functionality and balance in chronic hemiparetic patients following a stroke.MethodsThe 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.ResultsData collection is currently on-going and results are expected in 2021.DiscussionLE-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 registrationwww.ensaiosclinicos.gov.brRBR-467cv6. Registered on 10 October 2017. “Effects of Lower Extremities - Constraint Induced Therapy on gait and balance function in chronic hemipretic post-stroke patients”.
Highlights
Protocols involving intensive practice have shown positive outcomes
lower extremity constraint-induced movement therapy (LE-Constraint induced movement therapy (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
The following research question was established to examine the effects of LE-CIT vs intensive conventional therapy on gait functionality and balance, as well as the transference of these gains in therapy to the environment outside the clinical setting in chronic hemiparetic patients following a stroke: is LE-CIT more effective compared with intensive conventional therapy with regard to gait functionality and balance in people suffering from stroke?
Summary
Study design The study adopts a randomized, controlled, singleblinded study design in people suffering from stroke in the chronic stage of recovery. The physiotherapist responsible for this group is experienced in stroke rehabilitation and has been working in this area for 10 years This conventional training can be defined as intervention without technological resources, using handling, verbal commands, positioning, gait training and/ or pre-walking activities such as climbing stairs, balance training, lower limb strengthening, and other exercises that require standing and shifting weight to the impaired side [29]. Self-reported measure Lower Extremity/Activity Log: This is a structured interview, conducted by the therapist that evaluates how effectively subjects use their affected leg outside of the clinic setting in 14 common daily life activities on a scale that scores from 0 to 10 and quantifies functional performance (0 does not do and 10 does it normally) and the confidence with which the patient performs these activities (0 does not have confidence so does not do the task and 10 feels completely secure about doing the task). The results will be described with mean and standard deviation for each group and mean and standard deviation of differences between groups and confidence interval
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