- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373436
Effects of Constraint-induced Therapy for the Scapular Kinematics in Patients With Severe Chronic Hemiparesis
Effects of Constraint-induced Therapy for the Scapular Kinematics and Related to the Quality of Movement in Patients With Severe Chronic Hemiparesis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natalia D Pereira, Phd Student
- Phone Number: 55 11 981148153
- Email: nat_duarte@yahoo.com.br
Study Contact Backup
- Name: Paula R Camargo, Phd
- Email: paularesendecamargo@gmail.com
Study Locations
-
-
SP
-
Salto, SP, Brazil, 13323-675
- Recruiting
- Natalia Duarte Pereira
-
Contact:
- Carlos H Furtado
- Phone Number: 1140983246
- Email: carloshenrique_furtado@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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. |
Other: Control
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one day
|
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.
|
one day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Natalia D Pereira, Phd Student, UFScarlos
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFSaoCarlos
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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