StrokeNCT02373436
Effects of Constraint-induced Therapy for the Scapular Kinematics in Patients With Severe Chronic Hemiparesis
A study testing Constraint Induced Therapy in people with Stroke, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The hemiparesis is one of the most important sequelae of stroke, and generally have greater impairment in the upper limb (UL) contralateral to the brain injury. To obtain greater amount of use and most affected UL movement quality, studies have described as a rehabilitation technique constraint Induced Therapy (CIT). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Constraint Induced Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having suffered a stroke at least six months (chronic hemiparesis);
- Present score ≤ 2.5 in the range of amount of MAL movement featuring asymmetrical use of members superiores37;
- Be able to sit without support in the trunk for 10 minutes or more;
- They should have a designated caregiver available for assistance 24 hours a day for 2 weeks CIT protocol;
- They should be able to, using any method hold, grab a towel a table, lift it a few inches, and release;
- Understand all instructions given by the researchers (have to score ≥ cutoff point according to education in the Mini Mental State Examination - where the cutoff points are: 20 for illiterates, 25 one to four years of schooling, 26 , 5 for five to eight years, 28 to nine to 11, and 29 over 11 years of schooling 56).
Who cannot join
- Since this protocol is designed for people with severe paralysis UL participants who have active upper handle extension at 10 ° extension of two or more fingers greater than 10 ° and abducting the thumb over 10 ° or higher score 30 that the UL session of the Fugl Meyer scale, will be deleted.
- Individuals who possess double hemiplegia; other musculoskeletal or neurological conditions disabling; submit aphasia understanding, ie, not being able to meet verbal commands;
- Patients undergoing botulinum toxin in less than three months; Present BMI greater than 28 kg / m2.
Trial locations and contacts
1 site in 1 country.
Paula R Camargo, Phd contact
Brazil1 site, 1 recruiting
- Recruiting
Natalia Duarte Pereira
Salto, São Paulo, 13323-675
Carlos H Furtado, 1140983246, carloshenrique_furtado@hotmail.com
About this study
Official title: Effects of Constraint-induced Therapy for the Scapular Kinematics and Related to the Quality of Movement in Patients With Severe Chronic Hemiparesis
The hemiparesis is one of the most important sequelae of stroke, and generally have greater impairment in the upper limb (UL) contralateral to the brain injury. To obtain greater amount of use and most affected UL movement quality, studies have described as a rehabilitation technique constraint Induced Therapy (CIT). The objectives of this study will evaluate the effect of CIT in severe hemiparetics patients in the quantity and quality of movement UL and grip strength, and the relation between the scapular kinematics and trunk with the quality of movement measured clinically. Randomized crossover study with systematic reviews in AB mode, where A is the baseline to the evaluation of the period of 2 weeks without any intervention and B, the two-week period with intervention. One group will start with the intervention period (BA) and the other group with the period without intervention (AB). The intervention will be for 3 hours / day, 5x / week for two weeks and use of wrist and fingers restriction UL unaffected. To evaluate the quality and quantity of UL use in real environment will be used to Motor Activity Log (MAL), to quantify the motor skill the Wolf Motor Function Test (WMFT), the 3D movement of the scapula and trunk during arm elevation and functional activities of the UL will be measured by the electromagnetic tracking system and grip strength by hand dynamometer.
Read the detailed description
Randomized crossover study with systematic reviews in AB mode, where A is the baseline to the evaluation of the period of 2 weeks without any intervention and B, the two-week period with intervention, developed in the Evaluation Laboratory and complex intervention of shoulder at the Federal University of São Carlos (UFSCar).
Patients will be divided into two groups through the online tool www.randomization.com. One group will start with the intervention period (BA) and the other group with the period without intervention (AB). As the evaluator will not know the distribution of patients in groups, will be blinded as to the pre and post intervention.
The quantity variables, quality of movement, time to perform tasks and grip strength UL measures the MAL and WMFT, will be evaluated in five moments: at baseline, at the end of phase A, at the end of phase B, and monitoring of 1 and 3 months after the crossover period. The evaluation of scapular kinematics and trunk occur only at the beginning and the four-week period ends.
Measures shall be performed by the principal investigator who is a physiotherapist who trained for Group Research Therapy Induced by restraining the University of Alabama at Birmingham in 2008, headed by Edward Taub (creator of the technique) and David Morris. The intervention will be carried out by three other physical therapists with the same training. Thus, the protocol will be based on the principles recommended by the Extremity Constraint-Induced Therapy Evaluation (EXCITE), a project that involved seven centers of North American research.
The sample size is calculated for the main variables, quality movement measured by LAM. The effect size considered to be clinically relevant to the MAL is 1.0 on a scale from 0 to 5. The standard deviation of this variable in the population of severe hemiparesis found in other studies was. With a power of 80% and an α-probability error of 5% would require 16 patients in total.
- Conditions
- Stroke
- Being tested
- Constraint Induced Therapy, Control
- Keywords
- Upper Extremity, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint Induced TherapyOther
They will be instructed to remain with the mitt in UL less affected by 90% of the hours in which to stay awake beyond the training period.
The training will consist of 30 minutes for the transfer package, interview by items of MAL, and 2 hours and 30 minutes with four tasks of Shaping, and Task Practice.
The Transfer Package consists of a compromise agreement, held at the end of the first day of practice, in which the individual undertakes to complete:
The Shaping is a training method that makes it difficult gradually according to the motor capacity of each individual. It will be taken care of including tasks using all joints (shoulder, elbow, wrist and fingers), giving priority to the individual in need.
The individual will be instructed not to remove the trunk of the chair, and each task is repeated 10 times in no more than 45s.
The Task Practice promotes increased motor function during functional activities. For all individuals will be held the same function: meal.
ControlOther
This group has no intervention. They will wear a mitt that don't limit the use of the fingers and wrist. This is only to ensure blinding of the measurer
| Study group | Role | What they receive |
|---|---|---|
| Constraint Induced Therapy | Experimental | All participants will receive a glove that limits the use of the fingers and wrist, and can be placed by the participant. They will be instructed to remain with the mitt in UL less affected by 90% of the hours in which to stay awake beyond the training period.
The intervention training will consist of 30 minutes of exposure of the transfer package, the interview with the items in the MAL, and 2 hours and 30 minutes with about four task Shaping, which may vary according to the needs of each individual, and Task Practice, standardized to be the same for all individuals. Receives: Other: Constraint Induced Therapy |
| Control | Other | They will wear a mitt that don't limit the use of the fingers and wrist. This is only to ensure blinding of the measurer Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement of the scapula and trunk through kinematic
The movements of the scapula, humerus and trunk will be measured during functional tasks and elevation of the arm.
Measured: one day
Secondary outcomes (2)
Wolf Motor Function Test
The WMFT be used for the evaluation of the UL function and dexterity. It is a test with 15 functional tasks that are timed and filmed following the instructions of a manual, the maximum time allowed for completion of the 120s task. The movement of the quality score will be performed by shooting according to functional ability scale.
Measured: one day
Quantity and quality of the UL use
The amount of the UL use and the quality of movement will be reported by the participant for this structured interview called motor activity log.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, NATALIA DUARTE PEREIRA, Universidade Federal de Sao Carlos
- Investigators
- Natalia D Pereira, Phd Student, Principal investigator, UFScarlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373436
- Sponsor's protocol ID
- UFSaoCarlos
- Status last verified
- May 2015
- First submitted
- 7 Feb 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Constraint-induced Therapy for the Scapular Kinematics and Related to the Quality of Movement in Patients With Severe Chronic Hemiparesis
- ClinicalTrials.gov ID
- NCT02373436
- Acronym / sponsor ID
- UFSaoCarlos
- Conditions
- Stroke
- Keywords
- Upper Extremity, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hemiparesis is one of the most important sequelae of stroke, and generally have greater impairment in the upper limb (UL) contralateral to the brain injury. To obtain greater amount of use and most affected UL movement quality, studies have described as a rehabilitation technique constraint Induced Therapy (CIT). The objectives of this study will evaluate the effect of CIT in severe hemiparetics patients in the quantity and quality of movement UL and grip strength, and the relation between the scapular kinematics and trunk with the quality of movement measured clinically. Randomized crossover study with systematic reviews in AB mode, where A is the baseline to the evaluation of the period of 2 weeks without any intervention and B, the two-week period with intervention. One group will start with the intervention period (BA) and the other group with the period without intervention (AB). The intervention will be for 3 hours / day, 5x / week for two weeks and use of wrist and fingers restriction UL unaffected. To evaluate the quality and quantity of UL use in real environment will be used to Motor Activity Log (MAL), to quantify the motor skill the Wolf Motor Function Test (WMFT), the 3D movement of the scapula and trunk during arm elevation and functional activities of the UL will be measured by the electromagnetic tracking system and grip strength by hand dynamometer.
Detailed description
Randomized crossover study with systematic reviews in AB mode, where A is the baseline to the evaluation of the period of 2 weeks without any intervention and B, the two-week period with intervention, developed in the Evaluation Laboratory and complex intervention of shoulder at the Federal University of São Carlos (UFSCar).
Patients will be divided into two groups through the online tool www.randomization.com. One group will start with the intervention period (BA) and the other group with the period without intervention (AB). As the evaluator will not know the distribution of patients in groups, will be blinded as to the pre and post intervention.
The quantity variables, quality of movement, time to perform tasks and grip strength UL measures the MAL and WMFT, will be evaluated in five moments: at baseline, at the end of phase A, at the end of phase B, and monitoring of 1 and 3 months after the crossover period. The evaluation of scapular kinematics and trunk occur only at the beginning and the four-week period ends.
Measures shall be performed by the principal investigator who is a physiotherapist who trained for Group Research Therapy Induced by restraining the University of Alabama at Birmingham in 2008, headed by Edward Taub (creator of the technique) and David Morris. The intervention will be carried out by three other physical therapists with the same training. Thus, the protocol will be based on the principles recommended by the Extremity Constraint-Induced Therapy Evaluation (EXCITE), a project that involved seven centers of North American research.
The sample size is calculated for the main variables, quality movement measured by LAM. The effect size considered to be clinically relevant to the MAL is 1.0 on a scale from 0 to 5. The standard deviation of this variable in the population of severe hemiparesis found in other studies was. With a power of 80% and an α-probability error of 5% would require 16 patients in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constraint Induced Therapy | Experimental | Other: Constraint Induced TherapyAll participants will receive a glove that limits the use of the fingers and wrist, and can be placed by the participant. They will be instructed to remain with the mitt in UL less affected by 90% of the hours in which to stay awake beyond the training period. The intervention training will consist of 30 minutes of exposure of the transfer package, the interview with the items in the MAL, and 2 hours and 30 minutes with about four task Shaping, which may vary according to the needs of each individual, and Task Practice, standardized to be the same for all individuals. |
| Control | Other | Other: ControlThey will wear a mitt that don't limit the use of the fingers and wrist. This is only to ensure blinding of the measurer |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having suffered a stroke at least six months (chronic hemiparesis);
- Present score ≤ 2.5 in the range of amount of MAL movement featuring asymmetrical use of members superiores37;
- Be able to sit without support in the trunk for 10 minutes or more;
- They should have a designated caregiver available for assistance 24 hours a day for 2 weeks CIT protocol;
- They should be able to, using any method hold, grab a towel a table, lift it a few inches, and release;
Key exclusion criteria (3 listed)
- Since this protocol is designed for people with severe paralysis UL participants who have active upper handle extension at 10 ° extension of two or more fingers greater than 10 ° and abducting the thumb over 10 ° or higher score 30 that the UL session of the Fugl Meyer scale, will be deleted.
- Individuals who possess double hemiplegia; other musculoskeletal or neurological conditions disabling; submit aphasia understanding, ie, not being able to meet verbal commands;
- Patients undergoing botulinum toxin in less than three months; Present BMI greater than 28 kg / m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constraint Induced TherapyThey will be instructed to remain with the mitt in UL less affected by 90% of the hours in which to stay awake beyond the training period. The training will consist of 30 minutes for the transfer package, interview by items of MAL, and 2 hours and 30 minutes with four tasks of Shaping, and Task Practice. The Transfer Package consists of a compromise agreement, held at the end of the first day of practice, in which the individual undertakes to complete: The Shaping is a training method that makes it difficult gradually according to the motor capacity of each individual. It will be taken care of including tasks using all joints (shoulder, elbow, wrist and fingers), giving priority to the individual in need. The individual will be instructed not to remove the trunk of the chair, and each task is repeated 10 times in no more than 45s. The Task Practice promotes increased motor function during functional activities. For all individuals will be held the same function: meal. | Other | Constraint Induced Therapy |
| ControlThis group has no intervention. They will wear a mitt that don't limit the use of the fingers and wrist. This is only to ensure blinding of the measurer | Other | Control |
Primary outcome
Movement of the scapula and trunk through kinematic
Time frame: one day
The movements of the scapula, humerus and trunk will be measured during functional tasks and elevation of the arm.
2 secondary outcomes
Wolf Motor Function Test
Time frame: one day
Quantity and quality of the UL use
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula R Camargo, Phd contact
Natalia D Pereira, Phd Student principal investigator
UFScarlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint Induced Therapy in people with Stroke, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalia D Pereira, Phd Student (55 11 981148153, nat_duarte@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement of the scapula and trunk through kinematic (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015; AzTrials last refreshed its copy on 7 Nov 2026.