Effects of Constraint-induced Therapy for the Scapular Kinematics in Patients With Severe Chronic Hemiparesis

NCT ID: NCT02373436

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-07-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Constraint Induced Therapy

Intervention Type: OTHER

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.

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

Group Type: OTHER

Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

NATALIA DUARTE PEREIRA

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natalia D Pereira, Phd Student

Role: PRINCIPAL_INVESTIGATOR

UFScarlos

Locations

Natalia Duarte Pereira

Salto, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Natalia D Pereira, Phd Student

Role: CONTACT

nat_duarte@yahoo.com.br

55 11 981148153

Paula R Camargo, Phd

Role: CONTACT

paularesendecamargo@gmail.com

Facility Contacts

Carlos H Furtado

Role: primary

carloshenrique_furtado@hotmail.com

1140983246

Other Identifiers

UFSaoCarlos

Identifier Type: -

Identifier Source: org_study_id