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

NCT02373436 | Unknown DMC

• 1 other identifier: UFSaoCarlos
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Upper Extremity; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  one day

Secondary Outcomes (2)

• Wolf Motor Function Test

  one day

• Quantity and quality of the UL use

  one day

Study Arms (2)

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.

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

Other: Control

Interventions

Constraint Induced Therapy 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.

Constraint Induced Therapy

Control 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

Control

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Natalia Duarte Pereira

Salto, São Paulo, 13323-675, Brazil

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Natalia D Pereira, Phd Student

  UFScarlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia D Pereira, Phd Student

CONTACT

55 11 981148153; nat_duarte@yahoo.com.br

Paula R Camargo, Phd

CONTACT

paularesendecamargo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: February 7, 2015
• First Posted: February 27, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

BR (1)