Stroke, not specified as haemorrhage or infarction Sequelae of stroke, not specified as haemorrhage or infarction
Conditions
Interventions
WE will select 40 patients. They will be allocated in two different groups (20 to each group): 1) Constraint Induced Therapy (CIT) and 2) Conventional intensive therapy - control group.
Patient from b
2° immediately after the end of the protocol (1-3 days after the last day) and 3° Six months after the end of the protocol.
The selected outcome mesures are: Three-dimensional gait analysis, LE/MAL (L
2- Behavioral strategies of adherence (transference package): are strategies used to improve the adherence through Monitoring, Problems Solving and Behavioral Contract.
The control group participants
Behavioural
Other
E02.779
G11.427.690
E01.370.600.250
Sponsors
Associação de Assistência a Criança com Deficiência
Universidade Federal de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Medical diagnoses of stroke, ischemic or hemorrhagic; stroke at least 6 months before study participation; clinically stable; hemiparesis caused by stroke; gait deficit caused by stroke; being able to begin hip and knee flexion on the affected side; moving from sitting to standing independently even with aid or support of upper limbs; being able of transferring while sitting independently; being able to sustain the body weight on the affected side even with support of another person and/or aid; being able of walking at least 10 meters with or without aid, with or without support of another person, barefoot; having only one or two main caregivers or relatives who live with the patient or spend substantial parts of the day with him; being available to go to the rehabilitation center for 17 consecutive days and staying there for 3 hours per day, 15 days of treatment and the first day for initial tests and the last day for the final tests; has not been subjected to orthopedic surgery for at least 6 months at the beginning of the protocol; has not been subjected to chemical block for at least 3 months at the beginning of the protocol; do not present an independent community gait.
Exclusion criteria
Exclusion criteria: Not accepting the protocol for which they were randomly allocated; having speech deficits that incapacitates the participant to understand and/or answer properly to evaluation scales and exercises selected for the protocol and having suffered any clinical event between the screening and the beginning of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that at the end of the study the CIT group had superior results to the control group in relation to the patient's perception of their performance and confidence in performing daily activities measured by LE-MAL, with an increase of at least 0.4 grades in average;It is expected that at the end of the study the CIT group had superior results to the control group in relation to gait performance with an increase of 30 meters in the distance covered in the 6-minute walk test, biomechanical quality of the gait evaluated by the gait laboratory.;It is expected that at the end of the study the CIT group had superior results to the control group in relation to balance with an increase of 3 grades in the Mini-BESTest. | — |
Secondary
| Measure | Time frame |
|---|---|
| Increased expression of brain growth factor neurotrophic evaluated by blood test after the end of the intervention. | — |
Countries
Brazil
Contacts
Public ContactElaine De Oliveira
Associação de Assistência a Criança com Deficiência
Outcome results
None listed