Clinical trial NCT02373436: Effects of Constraint-induced Therapy for the Scapular Kinematics in Patients With Severe Chronic Hemiparesis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Upper Extremity
Rehabilitation
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2015-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Movement of the scapula and trunk through kinematic
timeFrame: one day
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: one day
measure: Quantity and quality of the UL use
timeFrame: one day
Other outcomes:
Locations:
city: Salto
country: Brazil
facility: Natalia Duarte Pereira
state: SP
Study officials:
affiliation: UFScarlos
name: Natalia D Pereira, Phd Student
role: PRINCIPAL_INVESTIGATOR
References: