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Trial registered on ANZCTR


Registration number
ACTRN12610001091099
Ethics application status
Approved
Date submitted
6/12/2010
Date registered
13/12/2010
Date last updated
13/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Results of Constraint induced therapy in Brazil after stroke with the original protocol at the University of Alabama at Birmingham (UAB) and evaluated with the scales translated and adapted.
Scientific title
Results of Constraint induced therapy in Brazil after stroke with the original protocol at the University of Alabama at Birmingham (UAB) and evaluated with the scales translated and adapted.
Secondary ID [1] 253246 0
approval of the ethics committee with protocol number: 039/2010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
limited upper extremity function after stroke 258775 0
Condition category
Condition code
Stroke 258918 258918 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Constraint Induced intervention protocol with the three fundamentals of the technique apliedone on one with a physiotherapist. These include 1) repetitive, task oriented training of the more impaired Upper Extremity for three hours a day for 10 consecutive weekdays; 2) applying a transfer package of adherence-enhancing behavioral methods designed to transfer gains made in clinical setting to the patient´s real-world environment ; and 3) constraining the patient to use the more impaired Upper Extremity during walking hours over de course of treatment, sometimes by restraining the less impaired UE
'They were assessed using the Motor Activity Log (MAL) and Wolf Motor Funtion Test (WMFT). The evaluator administered standardized assessments before the participant constraint-induced training (pretest), after constraint-induced training (posttest), and 1, 3 and 6 months posttraining (follow-ups).
Intervention code [1] 257712 0
Rehabilitation
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259785 0
The Motor Activity Log is a semistructured interview of patients to assess the amount of use and quality of movement of the affected UL outside the therapeutic environment in 30 daily activities.
Timepoint [1] 259785 0
The evaluator administered standardized assessments to the participant 7 days before constraint-induced training (pretest), 3 days after constraint-induced training (posttest), and 1, 3 and 6 months posttraining (follow-ups).
Secondary outcome [1] 268562 0
The WMFT, which aims to assess the motor ability of the upper limbs of patients with hemiparesis, contains 15 timed tasks
Timepoint [1] 268562 0
The evaluator administered standardized assessments to the participant 7 days before constraint-induced training (pretest), 3 days after constraint-induced training (posttest), and 1, 3 and 6 months posttraining (follow-ups).

Eligibility
Key inclusion criteria
Chronic stroke (more than six months); an amount of use score less than 2.5 on the Motor Activity Log; minimal score on the Mini-Mental State Examination according to Bertolucci, et al.; shoulder, elbow, wrist, or fingers; Modified Ashworth Scale score greater than 2 in any joint; no balance problems sufficient to compromise safety when wearing the mitt.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
participant without active motion of at least 45 degrees of flexion and shoulder abduction, 20 degrees of elbow extension, 10 degrees of wrist extension, 10 degrees of abduction / extension of the thumb and at least 10 degrees of extension in more than two fingers of the thumb

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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] 3077 0
Brazil
State/province [1] 3077 0

Funding & Sponsors
Funding source category [1] 258177 0
Charities/Societies/Foundations
Name [1] 258177 0
Associacao de Assistencia a Crianca Deficiente
Address [1] 258177 0
Av. Professor Ascendino Reis,
724 Ibirapuera Sao Paulo SP
CEP: 04027-000
Country [1] 258177 0
Brazil
Primary sponsor type
Individual
Name
Natalia Duarte Pereira
Address
Centro de Ciencias da Saude e do Esporte - CEFID
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country
Brazil
Secondary sponsor category [1] 257352 0
Individual
Name [1] 257352 0
Isabella de Souza Menezes
Address [1] 257352 0
Av. Professor Ascendino Reis,
724 Ibirapuera Sao Paulo SP
CEP: 04027-000
Country [1] 257352 0
Brazil
Other collaborator category [1] 251719 0
Individual
Name [1] 251719 0
Sarah Monteiro dos Anjos
Address [1] 251719 0
Av. Professor Ascendino Reis,
724 Ibirapuera Sao Paulo SP
CEP: 04027-000
Country [1] 251719 0
Brazil

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Constraint induced movement therapy is a family of techniques that have been implemented to increase function in stroke patients. In Brazil there are already some published studies with the technique and although all studies showing positive results of TCI, the variability of these results is large. The aims of the study is to compare the results of the intervention protocol complete with the effects obtained in studies conducted in Brazil. The patients with chronic stroke underwent two weeks of treatment with three components of the technique for three hours a day. They were assessed using the Motor Activity Log (MAL) and Wolf Motor Funtion Test (WMFT). The evaluator administered standardized assessments before the participant constraint-induced training (pretest), after constraint-induced training (posttest), and 1, 3 and 6 months posttraining (follow-ups).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31993 0
Address 31993 0
Country 31993 0
Phone 31993 0
Fax 31993 0
Email 31993 0
Contact person for public queries
Name 15240 0
Natalia Duarte Pereira
Address 15240 0
Centro de Ciencias da Saude e do Esporte - CEFID
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country 15240 0
Brazil
Phone 15240 0
55 11 8114 8153
Fax 15240 0
Email 15240 0
nat_duarte@yahoo.com.br
Contact person for scientific queries
Name 6168 0
Natalia Duarte Pereira
Address 6168 0
Centro de Ciencias da Saude e do Esporte - CEFID
Rua Pascoal Simone, 358 - Coqueiros, Florianopolis - SC, CEP 88080-350
Country 6168 0
Brazil
Phone 6168 0
55 11 8114 8153
Fax 6168 0
Email 6168 0
nat_duarte@yahoo.com.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary