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Trial registered on ANZCTR


Registration number
ACTRN12611000411943
Ethics application status
Approved
Date submitted
11/01/2011
Date registered
20/04/2011
Date last updated
20/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Biomechanical and Functional Improvement Post Constraint-Induced Movement Therapy and Forced Use Therapy in Rehabilitation of Patients With Chronic Hemiparesis Post-Stroke
Scientific title
Improvement after Constraint-Induced Movement Therapy versus Forced Use Therapy in Hemiparetics Post-Stroke: a randomized clinical trial
Secondary ID [1] 253348 0
SISNEP - CAAE 0119.0.004.000-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 258885 0
hemiparesis 258886 0
Condition category
Condition code
Neurological 259025 259025 0 0
Other neurological disorders
Stroke 259026 259026 0 0
Ischaemic
Stroke 259027 259027 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257795 0
Rehabilitation
Comparator / control treatment
The Forced Use Therapy will be the control treatment. As described above the immobilisation, mobilisation, and stretching of the non-paretic UL will be the same that CIMT. The only difference is the estimulation protocol.
Immobilisation 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 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 were submitted to stretching. A series of 3 repetitions consisted of keeping the extension pressure for 45 seconds were performed. This procedure will enable the patient to have unrestricted movements for at least 60 minutes. Then, another immobilisation will be prepared using a new tubular mesh.
Control group
Active

Outcomes
Primary outcome [1] 259878 0
Lower limb function will be evaluated by using the Berg Balance Scale (BBS) and Fugl-Meyer Assessment of Motor Recovery (FMA).
The BBS assesses balance performance on 14 items. Each item has an ordinal scale of five alternatives ranging from 0 to 4 points. Therefore, the maximum score is 56 points.
The FMA evaluates the sensorimotor recovery of UL and LL post-stroke. The maximum scores are 66 and 34 points for upper and lower limbs, respectively, which defines a normal motor functio. In this case we only will use the 34 score.
Timepoint [1] 259878 0
Motor evaluation will be performed on a weekly basis during the 4-week experimental period and every 30 days after protocol for further three months. In this way, it will be carried out an initial evaluation (start), three weekly evaluations (1st, 2nd, and 3rd weeks), one final evaluation (4th week), and three follow-up evaluations (1st, 2nd, and 3rd months of follow-up).
Primary outcome [2] 266561 0
Gait analysis will be performed by using the 10-metre walk test (10mT) and Time-UP & Go test (TUG). The 10mT evaluates the time in seconds to walking a distance of 10 metres. The subjects will be instructed to conduct the test quickly and safely. In our work, the execution time of each evaluation test will be performed twice and this resulted in an average. TUG test measured (in seconds) the time the subject need to rise from a chair and walk a distance of 3 meters, return and sit down, without any assistance.
For both tests, the data of the start assessment will be normalized in percentage, corresponding to 100% of the time required to perform the test. Assessments of 1st, 2nd, and 3rd and 4th weeks, and 1st, 2nd, and 3rd months of follow-up, also will be normalized into the percentage, concerning the percentage of the start assessment.
Timepoint [2] 266561 0
Motor evaluation will be performed on a weekly basis during the 4-week experimental period and every 30 days after protocol for further three months. In this way, it will be carried out an initial evaluation (start), three weekly evaluations (1st, 2nd, and 3rd weeks), one final evaluation (4th week), and three follow-up evaluations (1st, 2nd, and 3rd months of follow-up).
Secondary outcome [1] 268754 0
The Stroke Impact Scale (SIS) version 3.037 will be used with the patients during their admission. SIS scale integrates significant dimensions of function and quality of life in a self-report. The version used has 59 questions and evaluates 8 domains (strength, hand function, performance and independence in activities of daily living, mobility, communication, emotion, memory and thought) with a maximum score of 295 points. In our study, we used only the items that assess the performance of activities of daily living, lower limb strength and locomotion (walking and transfers), resulting in a maximum score of 80 points.
Timepoint [1] 268754 0
This scale will be used during start and finish of the treatment (4th week), and in the follow up, 1st, 2nd, and 3rd months after the ending of the protocol.

Eligibility
Key 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.
Minimum age
35 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac arrhythmias, non-controlled blood pressure, and severe respiratory and cardiovascular problems.
Medications for treatment of stroke and hypertension will be accepted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
For randomization we wil use 40 sealed envelopes with the indication for an experimental treatment group. Each envelopes contains only one type of treatment. Each patient can freely choose a sealed envelope containing the assignment to an experimental group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using 40 envelopes with one of these two therapies inside. There are 20 with constraint-induced movement therapy and 20 with forced use therapy. After sealed the envelope, they were shuffled and put in a box. In the moment that the patient accepts make part of this study, he os she can choose any envelope inside the box.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3103 0
Brazil
State/province [1] 3103 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 258266 0
Government body
Name [1] 258266 0
FAPESP
Address [1] 258266 0
:: FAPESP ::
Rua Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - Sao Paulo/SP - Brasil
Tel: (+55) 11 3838 4000 Fax: (+55) 11 3645 2421
Country [1] 258266 0
Brazil
Primary sponsor type
University
Name
School of Medicine – University of Sao Paulo, Ribeirao Preto (USP-RP)
Address
Avenida dos Bandeirantes 3900, Monte Alegre
CEP: 14049-900, Ribeirao Preto - SP
Brasil
Country
Brazil
Secondary sponsor category [1] 257432 0
None
Name [1] 257432 0
Address [1] 257432 0
Country [1] 257432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260241 0
Ethics in research and human experimentation of the teaching Hospital of the Faculty of Medicine of the Sao Paulo University
Ethics committee address [1] 260241 0
Av. Bandeirantes, 3900 - Monte Alegre
CEP: 14049-900 Ribeirao Preto - SP
Brasil
Ethics committee country [1] 260241 0
Brazil
Date submitted for ethics approval [1] 260241 0
20/06/2006
Approval date [1] 260241 0
31/08/2006
Ethics approval number [1] 260241 0
5995/2006

Summary
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.
Trial website
We don't have a trial website
Trial related presentations / publications
FUZARO, A. C. ; VIANA, R. ; GUERREIRO, C. T. ; GALLETI, F. ; DE ARAUJO, J. E. Functional Improvement post forced use therapy in the rehabilitation of paretic lower limb post-stroke: treatment and follow-up. In: Wold Stroke Congress, 2010, Seoul. International Journal of Stroke, 2010. v. 5.
FUZARO, A. C. ; VIANA, R. ; GUERREIRO, C. T. ; GALLETI, F. ; DE ARAUJO, J. E. . Terapia de Uso Forcado Modificada no Tratamento Pos-AVE: Protocolo e Seguimento. In: XVIII Congresso Brasileiro de Fisioterapia, 2009, Rio de Janeiro. Fisioterapia & Pesquisa, 2009. v. 16.
In: I Congresso IBRO/LARC de Neurociencias da America Latina, Caribe e Peninsula Iberica, 2008, Buzios, RJ. FUZARO, A. C. ; VIANA, R.; GUERREIRO, C. T. ; GALLETI, F. ;DE ARAUJO, J. E. Alteracoes Funcionais Pos-Terapia do Uso Forcado na Reabilitacao do Membro Inferior do Paciente Hemiparetico. GUERREIRO, C. T. ; GALLETI, F. ; FUZARO, A. C. ; VIANA, R. ; DE ARAUJO, J. E. Correlatos Biomecanicos e Funcionais Pos-Terapia de Constricao com Inducao do Movimento na Reabilitacao do Membro Inferior de Pacientes com Hemiparesia: Analise de 30 dias de Follow Up. GALLETI, F. ; GUERREIRO, C. T. ; FUZARO, A. C. ; VIANA, R. ; DE ARAUJO, J. E. Alteracoes Biomecanicas e Funcionais Pos-Terapia de Constricao com Inducao de Movimento na Reabilitacao do Membro Superior de Pacientes com Hemiparesia: Analise de 30 Dias de Follow Up. DE ARAUJO, J. E. ; FUZARO, A. C. ; GUERREIRO, C. T. ; GALLETI, F.; VIANA, R.. Alteracoes Funcionais Pos-Terapia de Uso Forçado na Reabilitacao do Membro Superior do Paciente Hemiparetico: Analise de 30 Dias e de Follow UP.
In: XVII COBRAF, 2007, Sao Paulo. Revista Brasileira de Fisioterapia. Sao Carlos : Revista Brasileira de Fisioterapia, 2007. GUERREIRO, C. T. ; GALLETI, F. ; FUZARO, A. C. ; VIANA, R. ; DE ARAUJO, J. E. Efeitos da CIMT na reabilitacao do membro inferior de pacientes com hemiparesia cronica pos-AVC. GALLETI, F.; GUERREIRO, C. T. ; FUZARO, A. C. ; VIANA, R.; DE ARAUJO, J. E. Efeitos da CIMT na reabiliatacao do membro superior de pacientes com hemiparesia cronica pos-AVC. VIANA, R.; FUZARO, A. C. ; GUERREIRO, C. T. ; GALLETI, F.; DE ARAUJO, J. E. Alteracoes funcionais pos-terapia de uso forçado na reabilitacao de um paciente hemiparetico.
VIANA, R. ; FUZARO, A. C. ; GUERREIRO, C. T. ; GALLETI, F.; DE ARAUJO, J. E. Efeitos da terapia de uso forcado de movimento na reabilitacao do membro superior em pacientes portadores de sequelas cronicas de acidente vascular cerebral.. In: XV SIICUSP, 2007, Ribeirao Preto. Anais do XV SIICUSP, 2007.
FUZARO, A. C. ; GUERREIRO, C. T. ; VIANA, R. ; GALLETI, F. ; DE ARAUJO, J. E. Alteracoes Funcionais Pos-Terapia de Constricao com Inducao de Movimento na Reabilitacao de Paciente Hemiparetico. In: InterCOBRAF, 2006, Santos. Revista .Brasileira de Fisioterapia - Suplementos. Sao Carlos : Universidade Federal de Sao Carlos, 2006
FUZARO, A. C. ; GUERREIRO, C. T. ; VIANA, R. ; GALLETI, F.; DE ARAUJO, J. E. Correlatos Biomecanicos e Funcionais Pos-Terapia de Constricao com Inducao de Movimento na Reabiliatacao do Paciente Hemiparetico Cronico Pos -Acidente Vascular Cerebral: relato de caso. In: Mostra Cientifica de Trabalhos de Conclusao do Curso de Graduacao em Fisioterapia, 2006, Ribeirao Preto.
Public notes

Contacts
Principal investigator
Name 32035 0
Address 32035 0
Country 32035 0
Phone 32035 0
Fax 32035 0
Email 32035 0
Contact person for public queries
Name 15282 0
Joao Eduardo De Araujo
Address 15282 0
Laboratory of Bioengineering, Neuropsychobiology and Motor Behavior, Department of Biomechanics, Medicine and Rehabilitation of the Locomotor System, School of Medicine – University of Sao Paulo, Ribeirao Preto (USP-RP), Avenida dos Bandeirantes 3900, Ribeirao Preto (SP) 14049-900, Brazil
Country 15282 0
Brazil
Phone 15282 0
55+1636024416
Fax 15282 0
55+1636024413
Email 15282 0
araujoje@fmrp.usp.br
Contact person for scientific queries
Name 6210 0
Joao Eduardo De Araujo
Address 6210 0
Laboratory of Bioengineering, Neuropsychobiology and Motor Behavior, Department of Biomechanics, Medicine and Rehabilitation of the Locomotor System, School of Medicine – University of Sao Paulo, Ribeirao Preto (USP-RP), Avenida dos Bandeirantes 3900, Ribeirao Preto (SP) 14049-900, Brazil
Country 6210 0
Brazil
Phone 6210 0
55+1636024416
Fax 6210 0
55+1636024413
Email 6210 0
araujoje@fmrp.usp.br

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Summary results
Have study results been published in a peer-reviewed journal?
Other publications
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Results – basic reporting
Results – plain English summary