Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000698077
Ethics application status
Approved
Date submitted
16/07/2010
Date registered
24/08/2010
Date last updated
12/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Addition of Trunk Restraint to Home-Based Modified Constraint- Induced Movement Therapy after Stroke
Scientific title
Addition of Trunk Restraint to Home-Based Modified Constraint- Induced Movement Therapy after Stroke: A randomized controlled trial
Secondary ID [1] 252238 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke survivors 257756 0
Condition category
Condition code
Neurological 257934 257934 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group will undertake modified Constraint-induced movement therapy (CIMT) and trunk restraint during two weeks of intensive training, five times a week, three hours daily. They will be required to use a glove which will restrict their less affected wrist and fingers by 90% of the time they are awake during the 14 days. The trunk restraint will be performed by an eight-shape clavicle immobilizer, with a seat belt strap with a buckle that fits to the size of the trunk of each individual. This restraint will not permit upper trunk movements. Training will be performed by 30 minutes of the transfer package exposure and application of the items of the Motor Activity Logo (MAL) (30 or 15 items daily alternately ). This will be followed by two hours and 30 minutes of four shaping tasks, which may vary, depending upon the needs of each individual. The task practice of making a snack, will be the same for all individuals. Between each exercise, individuals will be allowed to rest for at least 30 seconds. Individual adjustments will be made for better adaptation and the training will be supervised by a trained physiotherapist. Blood pressure measurements will be obtained before and after the intervention and their heart rate will be continuously monitored by a Polar heart rate monitor.
Intervention code [1] 256821 0
Rehabilitation
Comparator / control treatment
The control group will receive the same intervention, but without trunk restraints.
Control group
Active

Outcomes
Primary outcome [1] 258798 0
Amount and quality of the upper limb function, assessed by the Motor Activity Log
Timepoint [1] 258798 0
At baseline, post-intervention, and follow-up of one and three months
Secondary outcome [1] 264861 0
Reaching kinematics, upper limb and grip strength, and quality of life
Timepoint [1] 264861 0
At baseline, post-intervention, and follow-up of one and three months

Eligibility
Key inclusion criteria
Stroke survivors will be included if they are over 21 years of age; are within more than six months of their stroke; show inability to use the upper limb (assessed by 2.5 to zero (0) on the Motor Activity Log-Brazil); have a range of motion of at least 45 degrees of shoulder flexion and abduction, 20 degrees of elbow extension, 10 degrees of wrist extension and greater than zero degree in the metacarpophalangeal joints, as confirmed by goniometric active measures; are able to stand for two minutes (with support of their upper limbs, if necessary), can move safely and independently (e.g., in the use of the toilet); can understand and follow the instructions, as determined by Mini-mental state examination (Brucki et al., 2003); have shoulder pain less than three (mild pain) on the Shoulder Q scores (Turner-Stokes and Jackson, 2006), and report enough visual acuity with or without corrections.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with bilateral hemiplegia or other disabling neurological or musculoskeletal condition and who were submitted to the application of botulin toxin in less than three months (Blanton et al., 2006) will be excluded.

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)
The sequence of randomisation will be computer generated in random, computed blocks of four to six participants and maintained in sequentially numbered, sealed opaque envelopes. The envelopes will be prepared prior to the study by a trained physiotherapy student who is not involved in the study. Eligible participants will be randomly allocated to either, an experimental or a control group, after the contents of the sealed opaque envelopes are revealed by the treating therapist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of randomisation will be computer generated in random, computed blocks of four to six participants and maintained in sequentially numbered, sealed opaque envelopes. The envelopes will be prepared prior to the study by a trained physiotherapy student who is not involved in the study. Eligible participants will be randomly allocated to either, an experimental or a control group, after the contents of the sealed opaque envelopes are revealed by the treating therapist.
Masking / blinding
Blinded (masking 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
1/03/2010
Actual
27/02/2010
Date of last participant enrolment
Anticipated
Actual
20/11/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 2770 0
Brazil
State/province [1] 2770 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 257295 0
Other
Name [1] 257295 0
Brazilian Government Funding Agencies (CNPq and FAPEMIG)
Country [1] 257295 0
Brazil
Primary sponsor type
University
Name
Universidade Federal de Minas Gerais
Address
Avenida Antonio Carlos, 6627
31270-901 Belo Horizonte, Minas Gerais
Country
Brazil
Secondary sponsor category [1] 256540 0
None
Name [1] 256540 0
Address [1] 256540 0
Country [1] 256540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259322 0
Comite de Etica em Pesquisa da Universidade Federal de Minas Gerais
Ethics committee address [1] 259322 0
Avenida Antonio Carlos, 6627 - Unidade Administrativa II
31270-901 Belo Horizonte - Minas Gerais
Ethics committee country [1] 259322 0
Brazil
Date submitted for ethics approval [1] 259322 0
01/09/2009
Approval date [1] 259322 0
07/10/2009
Ethics approval number [1] 259322 0
0408.0.203.000-09

Summary
Brief summary
Studies which evaluated the effects of trunk restraint demonstrated that the hemiplegics who were trained with trunk restraint, demonstrated better performance in the tasks of reaching and grasping, with smaller displacements of the trunk, greater extension of the elbow, and better coordination between the joints than those who were trained without trunk restraint. Therefore, the aim of this study was to combine trunk restraint with modified CIMT (three hours of intensive training with a transfer package, shaping and task practice with restrictions of the less affected upper extremity of about 90% of the awake hours, during 14 days). The training protocol will be home-based to improve the transfer package. Therefore the specific research questions were:
1.Are two weeks of trunk restraint, plus modified home-based CIMT more effective than home-based modified CIMT alone in improving the amount and quality of the upper limb use and range of movement, smoothness, jerkiness, movement unity and velocity in the kinematics of reaching in chronic hemiplegics?
2.Are these gains maintained one and three months after the intervention has ceased?
Trial website
Trial related presentations / publications
1) Pereira ND, Ovando AC, Michaelsen SM, Anjos SM, Lima RCM, nascimento LR, Teixeira-Salmela LF. Motor Activity Log-Brazil: reliability and relationships with motor impairments in individuals with chronic stroke. Arquivos de Neuro-Psiquiatria. 2012,70:196-201.
2) Pereira ND, Michaelsen SM, Menezes IS, Ovando AC, Lima RCM, Teixeira-Salmela LF. Confiabilidade da versao brasileira do Wof Motor Function Test em adultos com hemiparesia. Revista Brasileira de Fisioterapia. 2011, 15:257-65.
3) Lima RCM, Teixiera-Salmela LF, Michaelsen SM. Effects of trunk restraint in addition to home-based modified constraint-induced movement therapy after stroke: a randomized controlled trial. International Journal of Stroke. 2012, 7: 258-64.
Public notes

Contacts
Principal investigator
Name 31404 0
Dr Renata Cristina Magalhaes Lima
Address 31404 0
Department of Physical Therapy Universidade Federal de Minas Gerais Avenida Antonio Carlos, 6627 - Campus Pampulha 31270-901 Belo Horizonte - MG
Country 31404 0
Brazil
Phone 31404 0
55-31-3409-7403
Fax 31404 0
55-31-34094783
Email 31404 0
renatalima.prof@newtonpaiva.br
Contact person for public queries
Name 14651 0
Dr Luci Fuscaldi Teixeira-Salmela
Address 14651 0
Department of Physical Therapy
Universidade Federal de Minas Gerais
Avenida Antonio Carlos, 6627 - Campus Pampulha
31270-901 Belo Horizonte - MG
Country 14651 0
Brazil
Phone 14651 0
55-31-3409-7403
Fax 14651 0
55-31-3409-4783
Email 14651 0
lfts@ufmg.br
Contact person for scientific queries
Name 5579 0
Dr Luci Fuscaldi Teixeira-Salmela
Address 5579 0
Department of Physical Therapy
Universidade Federal de Minas Gerais
Avenida Antonio Carlos, 6627 - Campus Pampulha
31270-901 Belo Horizonte - MG
Country 5579 0
Brazil
Phone 5579 0
55-31-3409-7403
Fax 5579 0
55-31-3409-4783
Email 5579 0
lfts@ufmg.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInfluences of hand dominance on the maintenance of benefits after home-based modified constraint-induced movement therapy in individuals with stroke.2014
N.B. These documents automatically identified may not have been verified by the study sponsor.