Effects of Constraint-induced Therapy for the Scapular Kinematics in Patients With Severe Chronic Hemiparesis
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|ClinicalTrials.gov Identifier: NCT02373436|
Recruitment Status : Unknown
Verified May 2015 by NATALIA DUARTE PEREIRA, Universidade Federal de Sao Carlos.
Recruitment status was: Recruiting
First Posted : February 27, 2015
Last Update Posted : May 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Constraint Induced Therapy Other: Control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effects of Constraint-induced Therapy for the Scapular Kinematics and Related to the Quality of Movement in Patients With Severe Chronic Hemiparesis|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||July 2016|
Experimental: Constraint Induced Therapy
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.
Other: Constraint Induced Therapy
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.
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
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
- 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.
- Wolf Motor Function Test [ Time Frame: one day ]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.
- Quantity and quality of the UL use [ Time Frame: one day ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373436
|Contact: Natalia D Pereira, Phd Student||55 11 firstname.lastname@example.org|
|Contact: Paula R Camargo, Phdemail@example.com|
|Natalia Duarte Pereira||Recruiting|
|Salto, SP, Brazil, 13323-675|
|Contact: Carlos H Furtado 1140983246 firstname.lastname@example.org|
|Principal Investigator:||Natalia D Pereira, Phd Student||UFScarlos|