Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Addition of Trunk Restraint to Home-Based Modified Constraint- Induced Movement Therapy after Stroke: A randomized controlled trial
Query!
Secondary ID [1]
252238
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Stroke survivors
257756
0
Query!
Condition category
Condition code
Neurological
257934
257934
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
256821
0
Rehabilitation
Query!
Comparator / control treatment
The control group will receive the same intervention, but without trunk restraints.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
258798
0
Amount and quality of the upper limb function, assessed by the Motor Activity Log
Query!
Assessment method [1]
258798
0
Query!
Timepoint [1]
258798
0
At baseline, post-intervention, and follow-up of one and three months
Query!
Secondary outcome [1]
264861
0
Reaching kinematics, upper limb and grip strength, and quality of life
Query!
Assessment method [1]
264861
0
Query!
Timepoint [1]
264861
0
At baseline, post-intervention, and follow-up of one and three months
Query!
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.
Query!
Minimum age
21
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/03/2010
Query!
Actual
27/02/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
20/11/2010
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
22
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
2770
0
Brazil
Query!
State/province [1]
2770
0
Minas Gerais
Query!
Funding & Sponsors
Funding source category [1]
257295
0
Other
Query!
Name [1]
257295
0
Brazilian Government Funding Agencies (CNPq and FAPEMIG)
Query!
Address [1]
257295
0
Avenida Antonio Carlos, 6627
31270-901 Belo Horizonte, Minas Gerais
Query!
Country [1]
257295
0
Brazil
Query!
Primary sponsor type
University
Query!
Name
Universidade Federal de Minas Gerais
Query!
Address
Avenida Antonio Carlos, 6627
31270-901 Belo Horizonte, Minas Gerais
Query!
Country
Brazil
Query!
Secondary sponsor category [1]
256540
0
None
Query!
Name [1]
256540
0
Query!
Address [1]
256540
0
Query!
Country [1]
256540
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
259322
0
Comite de Etica em Pesquisa da Universidade Federal de Minas Gerais
Query!
Ethics committee address [1]
259322
0
Avenida Antonio Carlos, 6627 - Unidade Administrativa II
31270-901 Belo Horizonte - Minas Gerais
Query!
Ethics committee country [1]
259322
0
Brazil
Query!
Date submitted for ethics approval [1]
259322
0
01/09/2009
Query!
Approval date [1]
259322
0
07/10/2009
Query!
Ethics approval number [1]
259322
0
0408.0.203.000-09
Query!
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?
Query!
Trial website
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
31404
0
Dr Renata Cristina Magalhaes Lima
Query!
Address
31404
0
Department of Physical Therapy Universidade Federal de Minas Gerais Avenida Antonio Carlos, 6627 - Campus Pampulha 31270-901 Belo Horizonte - MG
Query!
Country
31404
0
Brazil
Query!
Phone
31404
0
55-31-3409-7403
Query!
Fax
31404
0
55-31-34094783
Query!
Email
31404
0
[email protected]
Query!
Contact person for public queries
Name
14651
0
Dr Luci Fuscaldi Teixeira-Salmela
Query!
Address
14651
0
Department of Physical Therapy
Universidade Federal de Minas Gerais
Avenida Antonio Carlos, 6627 - Campus Pampulha
31270-901 Belo Horizonte - MG
Query!
Country
14651
0
Brazil
Query!
Phone
14651
0
55-31-3409-7403
Query!
Fax
14651
0
55-31-3409-4783
Query!
Email
14651
0
[email protected]
Query!
Contact person for scientific queries
Name
5579
0
Dr Luci Fuscaldi Teixeira-Salmela
Query!
Address
5579
0
Department of Physical Therapy
Universidade Federal de Minas Gerais
Avenida Antonio Carlos, 6627 - Campus Pampulha
31270-901 Belo Horizonte - MG
Query!
Country
5579
0
Brazil
Query!
Phone
5579
0
55-31-3409-7403
Query!
Fax
5579
0
55-31-3409-4783
Query!
Email
5579
0
[email protected]
Query!
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
Source
Title
Year of Publication
DOI
Embase
Influences 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.
Download to PDF