None listed
Conditions
Brief summary
Stroke is one of the major causes of death and disabilities in adult’s worldwide. In Brazil, stroke is the main cause of death, yielding the highest mortality rates by age group in Latin America. About two-thirds of the cases of stroke occur in low-medium income countries where their patient’s average age is 15 years younger than that of patients from developed countries. The majority of the stroke survivors have some degree of recovery, but more than 50% still present some cognitive, sensory or motor deficit. Because stroke affects posture and functional movements directly, paresis is the common, marked, persistent sequel present in upper (UL) and lower limbs (LL) or hemi-body. The decline in motor function is also correlated to balance. Hemiparetic patients have asymmetry during static motor activation for either sitting or standing postures as well as for dynamic functional movements such as gait. This asymmetry is related to changes in balance and can contribute to gait impairment. The hemi-paretic patient has low velocity during gait, asymmetry during orthostatic posture and functional movements, longer staying on the non-paretic lower limb, and increase in double support time. However, these patients may present a certain degree of deficiency in their balance as only 40% of them resume their normal gait speed. Several physiotherapeutic techniques are used for rehabilitation of post-stroke patients. An intensive motor rehabilitation favours recovery and promotes changes in the neuromuscular system by means of repeated tasks. One of the techniques using such a concept is the Constraint-Induced Movement Therapy (CIMT). The Forced-Use Therapy (FUT) is a modified version of CIMT, consisting of restricting only NPUL without training in order to force the use of the paretic side. In both therapies, the main target is also the motor rehabilitation of the paretic upper limb (PUL) although no directed activity is proposed. Forty subjects will take part of this study. The subjects will be randomized into two groups of experimental treatment. For randomization we will use sealed envelopes with the indication for an experimental treatment group and each patient will freely choose a envelope. The immobilisation for both therapies will be performed by means of a tubular mesh involving the non-paretic UL on abduction, rotating the shoulder internally, and allowing elbow flexion above 90o. It was maintained for 24 hours during five days a week over a period of four weeks. Only the patients allocated for CIMT group attended an exercise training program for 5 days a week during the whole experimental period. Each session lasted 50 minutes on average. The program followed a protocol consisting of kinesiotherapy and functional manual tasks for paretic UL. Motor evaluation was performed on a weekly basis (except for admission scale) during the 4-week experimental period and every 30 days after protocol for further three months. For theis admission we will use the Stroke Impact Scale (SIS) version 3.0. Lower limb function will be evaluated by using the Berg Balance Scale (BBS) and Fugl-Meyer Assessment of Motor Recovery (FMA). Gait analysis was performed by using the 10-metre walk test (10mT) and Time-UP & Go test (TUG). We will use Kruskal-Wallis One Way Analysis of Variance on Ranks (ANOVA on Ranks) for intragroups comparisons between the treatment weeks and the three follow-up months. Dunn´s post-hoc was used for any difference found at a significance level of p<0.05. For comparison between groups we used Mann-Whitney rank sum test with the same level of significance that the Dunn´s test.
Interventions
Both techinques, Constraint-Induced Moviment Therapy (CIMT) and Forced Use Therapy (FUT) use Immobilisation, mobilisation, and stretching of the non-paretic upper limb.
Immobilisation will be performed by means of a tubular mesh involving the non-paretic upper limb (UL) on abduction, rotating the shoulder internally, and allowing elbow flexion above 90 degrees. Immobilisation will be maintained for 24 hours during five days a week over a period of four weeks. The tubular mesh will be removed eve
Both techinques, Constraint-Induced Moviment Therapy (CIMT) and Forced Use Therapy (FUT) use Immobilisation, mobilisation, and stretching of the non-paretic upper limb. Immobilisation will be performed by means of a tubular mesh involving the non-paretic upper limb (UL) on abduction, rotating the shoulder internally, and allowing elbow flexion above 90 degrees. Immobilisation will be maintained for 24 hours during five days a week over a period of four weeks. The tubular mesh will be removed every day by the examiners for hygienisation, mobilisation, and muscle stretching of the UL with restriction. The non-paretic UL mobilisation will be performed by using traction techniques and joint circular movements, with 30 repetitions for each joint. All muscle groups of the UL will be submitted to stretching. A series of 3 repetitions consisted of keeping the extension pressure for 45 seconds will be performed. This procedure enabled the patient to have unrestricted movements for at least 60 minutes. Then, another immobilisation will be prepared using a new tubular mesh. Only the patients in the CIMT group attended an exercise training program for 5 days a week during the whole experimental period. Each session will last 50 minutes on average. The program will follow a protocol consisting of kinesiotherapy and functional manual tasks for paretic UL. Each session will includ a 5-10-minute warm-up period, scapula mobilisation, flexion exercises and shoulder abduction, flexion exercises and elbow extension, flexion movements, trunk extension and rotation associated with upper limb movements, flexion exercises and wrist extension, and functional activities such as unlocking a door, typing a telephone number, turning on the tap, turning off the light, among other tasks.The protocol will be applied to paretic UL only, whereas the non-paretic UL will be under no restriction of movements. The exercises will be performed at maximum range, and whenever possible with some resistance by the physiotherapist. The sessions will be consisted of three series of 10 repetitions of each exercise. The rest interval between the exercises will be determined for each individual patient in order to avoid fatigue and excessive tiredness. In the both groups LL will be not stimulated.
Sponsors
School of Medicine – University of Sao Paulo, Ribeirao Preto (USP-RP)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Hemiparesis, good cognition function, absence of joint blockage, preserved amplitude movement (AM), ability to ambulate alone, and upper lower movement at 20 and 10 degrees of active extension for wrist and metacarpophalangeal joint, respectively.
Exclusion criteria
Cardiac arrhythmias, non-controlled blood pressure, and severe respiratory and cardiovascular problems. Medications for treatment of stroke and hypertension will be accepted.
Outcome results
None listed